H1-antihistamines for chronic spontaneous urticaria
- PMID: 25397904
- PMCID: PMC6481497
- DOI: 10.1002/14651858.CD006137.pub2
H1-antihistamines for chronic spontaneous urticaria
Abstract
Background Chronic spontaneous urticaria (CSU) is characterised by the development of crops of red, itchy, raised weals or hives with no identifiable external cause.Objectives To assess the effects of H1-antihistamines for CSU.Search methods We searched the following databases up to June 2014: Cochrane Skin Group Specialised Register, CENTRAL (2014, Issue 5), MEDLINE(from 1946), EMBASE (from 1974) and PsycINFO (from 1806). We searched five trials registers and checked articles for references to relevant randomised controlled trials.Selection criteria We included randomised controlled trials of H1-antihistamines for CSU. Interventions included single therapy or a combination of H1-antihistamines compared with no treatment (placebo) or another active pharmacological compound at any dose.Data collection and analysis We used standard methodological procedures as expected by The Cochrane Collaboration.Our primary outcome measures were proportion of participants with complete suppression of urticaria: 'good or excellent' response,50% or greater improvement in quality of life measures, and adverse events.We present risk ratios (RR) with 95% confidence intervals(CIs). Main results We identified 73 studies (9759 participants); 34 studies provided data for 23 comparisons. The duration of the intervention was up to two weeks (short-term) or longer than two weeks and up to three months (intermediate-term).Cetirizine 10mg once daily in the short term and in the intermediate term led to complete suppression of urticaria by more participants than was seen with placebo (RR 2.72, 95% CI 1.51 to 4.91). For this same outcome, comparison of desloratadine versus placebo in the intermediate term (5 mg) (RR 37.00, 95% CI 2.31 to 593.70) and in the short term (20 mg) (RR 15.97, 95% CI 1.04 to 245.04)favoured desloratadine, but no differences were seen between 5 mg and 10 mg for short-term treatment.Levocetirizine 20 mg per day (short-term) was more effective for complete suppression of urticaria compared with placebo (RR 20.87,95% CI 1.37 to 317.60), and at 5 mg was effective in the intermediate term (RR 52.88, 95% CI 3.31 to 843.81) but not in the shortterm, nor was 10 mg effective in the short term.Rupatadine at 10 mg and 20 mg in the intermediate term achieved a 'good or excellent response' compared with placebo (RR 1.35,95% CI 1.03 to 1.77).Loratadine (10 mg) versus placebo (RR 1.86, 95% CI 0.91 to 3.79) and loratadine (10 mg) versus cetirizine (10 mg) (RR 1.05, 95%CI 0.76 to 1.43) over short-term and intermediate-term treatment showed no significant difference for 'good or excellent response' or for complete suppression of urticaria, respectively.Loratadine (10 mg) versus desloratadine (5 mg) (intermediate-term) showed no statistically significant difference for complete suppression of urticaria (RR 0.91, 95% CI 0.78 to 1.06) or for 'good or excellent response' (RR 1.04, 95% CI 0.64 to 1.71). For loratadine(10 mg) versus mizolastine (10 mg) (intermediate-term), no statistically significant difference was seen for complete suppression of urticaria (RR 0.86, 95% CI 0.64 to 1.16) or for 'good or excellent response' (RR 0.88, 95% CI 0.55 to 1.42).Loratadine (10mg) versus emedastine (2mg) (intermediate-term) showed no statistically significant difference for complete suppression(RR 1.04, 95% CI 0.78 to 1.39) or for 'good or excellent response' (RR 1.09, 95% CI 0.96 to 1.24); the quality of the evidence was moderate for this comparison.No difference in short-term treatment was noted between loratadine (10mg) and hydroxyzine (25mg) in terms of complete suppression(RR 1.00, 95% CI 0.32 to 3.10).When desloratadine (5 to 20 mg) was compared with levocetirizine (5 to 20 mg), levocetirizine appeared to be the more effective (P value < 0.02).In a comparison of fexofenadine versus cetirizine, more participants in the cetirizine group showed complete suppression of urticaria(P value < 0.001).Adverse events leading to withdrawals were not significantly different in the following comparisons: cetirizine versus placebo at 10 mg and 20 mg (RR 3.00, 95% CI 0.68 to 13.22); desloratadine 5 mg versus placebo (RR 1.46, 95% CI 0.42 to 5.10); loratadine 10 mg versus mizolastine 10 mg (RR 0.38, 95% CI 0.04 to 3.60); loratadine 10mg versus emedastine 2mg (RR 1.09, 95%CI 0.07 to 17.14);cetirizine 10 mg versus hydroxyzine 25 mg (RR 0.78, 95% CI 0.25 to 2.45); and hydroxyzine 25 mg versus placebo (RR 3.64, 95%CI 0.77 to 17.23), all intermediate term.No difference was seen between loratadine 10 mg versus mizolastine 10 mg in the proportion of participants with at least 50%improvement in quality of life (RR 3.21, 95% CI 0.32 to 32.33).Authors' conclusions Although the results of our review indicate that at standard doses of treatment, several antihistamines are effective when compared with placebo, all results were gathered from a few studies or, in some cases, from single-study estimates. The quality of the evidence was affected by the small number of studies in each comparison and the small sample size for many of the outcomes, prompting us to downgrade the quality of evidence for imprecision (unless stated for each comparison, the quality of the evidence was low).No single H1-antihistamine stands out as most effective. Cetirizine at 10 mg once daily in the short term and in the intermediate term was found to be effective in completely suppressing urticaria. Evidence is limited for desloratadine given at 5 mg once daily in the intermediate term and at 20 mg in the short term. Levocetirizine at 5 mg in the intermediate but not short term was effective for complete suppression. Levocetirizine 20 mg was effective in the short term, but 10 mg was not. No difference in rates of withdrawal due to adverse events was noted between active and placebo groups. Evidence for improvement in quality of life was insufficient.
Conflict of interest statement
Maulina Sharma: "I have represented the Cochrane Skin Group as a stakeholder for a NICE (National Institute for Health and Care Excellence) scoping workshop for chronic spontaneous urticaria: omalizumab 2014. I have received an honorarium as a speaker for a general practitioner (GP) educational event, which was donated to the charitable funds of the department. I have attended training and continuing medical education (CME) events that may have been sponsored in part by pharmaceutical industry. I have been a subinvestigator for clinical trials conducted in the Department of Dermatology, George Eliot Hospitals NHS Trust, Nuneaton, UK (2005 to 2006), in particular, the CUTE study (NCT00264303). I was not involved in writing of the results and received no payments for my involvement with the clinical trials." Cathy Bennett: "I am the proprietor of Systematic Research Ltd, a company providing research services; I am an employee of this company and received a consultancy fee for the production of this review. I have also received consultancy fees for other Cochrane reviews and work in evidence‐based medicine." Stuart N Cohen: Nothing to declare. Ben Carter: Nothing to declare.
Dr Karsten Weller was a clinical referee: "I received lecture fees or advisory board fees from Novartis, Uriach, FAES, MSD (Essex Pharma), UCB or was involved in clinical studies with drugs from these companies."
Figures
Update of
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- Staevska, M, Gugutkova M, Lazarova C, Kralimarkova T Dimitrov V, Zuberbier T, et al. Night‐time sedating H1‐antihistamine increases daytime somnolence but not treatment efficacy in chronic spontaneous urticaria: a randomized controlled trial. British Journal of Dermatology 2014;171(1):148‐54. [MEDLINE: ] - PMC - PubMed
Thompson 2000 Study 1 {published data only}
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- Thompson A, Finn A, Schoenwetter W. Effect of 60 mg BID fexofenadine HCL on quality of life, work productivity, and regular activity in patients with chronic idiopathic urticaria. Annals of Allergy, Asthma & Immunology 1999;82:122. [CENTRAL: CN‐00285038] - PubMed
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- Thompson AK, Finn AF, Schoenwetter WF. Effect of 60 mg twice‐daily fexofenadine HCl on quality of life, work and classroom productivity, and regular activity in patients with chronic idiopathic urticaria. Journal of the American Academy of Dermatology 2000;43(1 Pt 1):24‐30. [MEDLINE: ] - PubMed
Thompson 2000 Study 2 {published data only}
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- Thompson A, Finn A, Schoenwetter W. Effect of 60 mg BID fexofenadine HCL on quality of life, work productivity, and regular activity in patients with chronic idiopathic urticaria. Annals of Allergy, Asthma & Immunology 1999; Vol. 82:122. [CENTRAL: CN‐00285038]
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- Thompson AK, Finn AF, Schoenwetter WF. Effect of 60 mg twice‐daily fexofenadine HCl on quality of life, work and classroom productivity, and regular activity in patients with chronic idiopathic urticaria. Journal of the American Academy of Dermatology 2000;43(1 Pt 1):24‐30. [MEDLINE: ] - PubMed
Wan 2009 {published data only}
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- Wan KS. Efficacy of leukotriene receptor antagonist with an anti‐H1 receptor antagonist for treatment of chronic idiopathic urticaria. Journal of Dermatological Treatment 2009; Vol. 20, issue 4:194‐7. [MEDLINE: ] - PubMed
Wang 2012 {published data only}
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- Wang HJ, Zhang JA, Yu JB. Clinical observation of long‐term decrement mizolastine therapy in the treatment of chronic urticaria. Journal of Clinical Dermatology 2012; Vol. 41, issue 7:440‐2. [EMBASE: 2012596086]
Weller 2013 {published data only}
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- Weller K, Ardelean E, Scholz E, Martus P, Zuberbier T, Maurer M. Can on‐demand non‐sedating antihistamines improve urticaria symptoms? A double‐blind, randomized, single‐dose study. Acta Dermato‐Venereologica 2013; Vol. 93, issue 2:168‐74. [MEDLINE: ] - PubMed
Wu 2008 {published data only}
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- Wu S‐X, Guo N‐R, Chen J, Sun J‐F. Different dosages of azelastine and in combination of cimetidine in the treatment of chronic urticaria. Journal of Clinical Dermatology 2008;37(3):194‐6. [EMBASE: 2008197256]
Yin 2003a {published data only}
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- Yin R, Hao F, Xiang MM, Shun RS, Deng J. A clinical trial of levocetirizine in the treatment of chronic idiopathic urticaria. Journal of Clinical Dermatology 2003;32(8):477‐8.
Yin 2003b {published data only}
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- Yin R, Diao QC, Ye QY. Clinical research of three antihistamines in the treatment of chronic idiopathic urticaria. Journal of Clinical Dermatology 2003b;32(11):675‐77.
Zou 2002 {published data only}
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- Zou Y, Chen XP. Curative effect of desloratadine in the treatment of chronic idiopathic urticaria. Central China Medical Journal 2002;27(2):75‐6.
Zuberbier 2010 {published data only}
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- Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, et al. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi‐centre, double‐blind, randomized, placebo‐controlled study. Allergy 2010; Vol. 65, issue 4:516‐28. [MEDLINE: ] - PubMed
References to studies excluded from this review
Aberer 2001 {published data only}
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- Aberer W, Kränke B. One‐year treatment of chronic urticaria with mizolastine: efficacy and safety. Journal of the European Academy of Dermatology & Venereology 2001; Vol. 15, issue 1:77‐9. [MEDLINE: ] - PubMed
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Alomar 1990b {published data only}
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Anonymous 1989 {published data only}
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Anonymous 1992 {published data only}
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Arendt 1989 {published data only}
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Bakos 1985 {published data only}
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Baraf 1976 {published data only}
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Bernd 1989 {published data only}
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Bernstein 1986 {published data only}
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Bernstein 2002 {published data only}
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Bian 1996 {published data only}
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- Bian ZP, Qian ML, Mao NE, Luo BG. A randomised controlled trial of loratadine versus astemizole in the treatment of chronic urticaria (Chinese). Journal of Clinical Dermatology 1996;25(3):165‐6.
Bleehen 1987 {published data only}
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- Bleehen SS, Thomas SE, Greaves MW, Newton J, Kennedy CT, Hindley F, et al. Cimetidine and chlorpheniramine in the treatment of chronic idiopathic urticaria: a multi‐centre randomized double‐blind study. British Journal of Dermatology 1987;117(1):81‐8. [MEDLINE: ] - PubMed
Bloom 2004 {published data only}
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- Bloom M, Staudinger H, Herron J. Safety of desloratadine syrup in children. Current Medical Research & Opinion 2004;20(12):1959‐65. [MEDLINE: ] - PubMed
Brunet 1990 {published data only}
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- Brunet C, Bedard PM, Hebert J. Effects of H1‐antihistamine drug regimen on histamine release by non‐lesional skin mast cells of patients with chronic urticaria. Journal of Allergy & Clinical Immunology 1990;86(5):787‐93. [MEDLINE: ] - PubMed
Cainelli 1986 {published data only}
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Camarasa 2001 {published data only}
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- Camarasa JM, Aliaga A, Fernandez‐Vozmediano JM, Fonseca E, Iglesias L, Tagarro I. Azelastine tablets in the treatment of chronic idiopathic urticaria. Phase III, randomised, double‐blind, placebo and active controlled multicentric clinical trial. Skin Pharmacology & Applied Skin Physiology 2001;14(2):77‐86. [MEDLINE: ] - PubMed
Cassano 2007 {published data only}
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- Cassano N, Cesare G, Tsapoga V, Vena GA. Cyclosporin in chronic urticaria: state of the art [Ciclosporina nell'orticaria cronica: stato dell'arte]. Annali Italiani di Dermatologia Allergologica Clinica e Sperimentale 2007;61(1):6‐11. [EMBASE: 2007300249]
Cerio 1984 {published data only}
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- Cerio R, Lessof MH. Treatment of chronic idiopathic urticaria with terfenadine. Clinical Allergy 1984; Vol. 14, issue 2:139‐41. [MEDLINE: ] - PubMed
Chatterjee 1996 {published data only}
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- Chatterjee G, Banerjee PK. A comparison of the efficacy of cetirizine and terfenadine in chronic idiopathic urticaria. Indian Journal of Dermatology 1996;41(3):82‐6. [CENTRAL: CN‐00663322]
Chen 2005 {published data only}
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- Chen LY, Guo YQ. Observation on short‐term therapeutic effect of Bo's abdominal acupuncture on chronic urticaria [Chinese]. Zhongguo Zhenjiu 2005;25(11):768‐70. [MEDLINE: ] - PubMed
Church 2009 {published data only}
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Cook 1983 {published data only}
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- Cook LJ, Shuster S. Lack of effect of cimetidine in chronic‐idiopathic urticaria. Acta Dermato‐Venereologica 1983;63(3):265‐7. [MEDLINE: ] - PubMed
Demaubeuge 1982 {published data only}
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- Demaubeuge J, Tennstedt D, Broux R. Does mast cell protection plus mediator antagonism surpass the effect of a classic antihistaminic in the treatment of chronic urticaria? A double‐blind comparison of oxatomide and mequitazine. Dermatologica 1982; Vol. 164, issue 6:386‐94. [MEDLINE: ] - PubMed
Devillier 2007 {published data only}
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Devillier 2008 {published data only}
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Dhurandhar 1987 {published data only}
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- Dhurandhar MW, Sharma SD. Azatadine versus pheniramine in chronic urticaria. Medicine and Surgery 1987;27(9):15‐7. [EMBASE: 1988189679]
Diller 1983 {published data only}
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- Diller G, Orfanos CE. Management of idiopathic urticaria with H1 + H2 antagonists. A crossover double blind long‐term study [Behandlung der idiopathischen urticaria mit H1+H2 antagonisten. Ergebnisse einer crossover‐doppelblind‐langzeitstudie]. H+G Zeitschrift für Hautkrankheiten 1983;58(11):785‐93. [EMBASE: 1983171814] - PubMed
Dockx 1981 {published data only}
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- Dockx P, Vertommen J, Daele R. Oxatomide effective in chronic urticaria: a double‐blind comparison with a placebo. Current Therapeutic Research Clinical and Experimental 1981;29(3 II):510‐6. [EMBASE: 1981227927]
Farshchain 2002 {published data only}
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- Farshchain M. Comparison of ketotifen effectiveness with hydroxyzine in the treatment of pruritus and chronic idiopathic urticaria [Abstract]. 20th World Congress of Dermatology Paris, 1st to 5th July 2002. Annales de Dermatologie et de Venereologie 2002;129:P1667.
Ferguson 1985 {published data only}
Fox 1986 {published data only}
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- Fox RW, Lockey RF, Bukantz SC, Serbousek D. The treatment of mild to severe chronic idiopathic urticaria with astemizole: double‐blind and open trials. Journal of Allergy & Clinical Immunology 1986;78(6):1159‐66. [MEDLINE: ] - PubMed
Fredriksson 1986 {published data only}
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- Fredriksson T, Hersle K, Hjorth N, Mobacken H, Persson T, Salde L, et al. Terfenadine in chronic urticaria: a comparison with clemastine and placebo. Cutis 1986; Vol. 38, issue 2:128‐30. [MEDLINE: ] - PubMed
Gao 2009 {published data only}
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- Gao H, Li XZ, Ye WW, Zhou BY, Jin YJ, Qiu Y, et al. [Influence of penetrative needling of Shendao (GV 11) on the symptom score and serum IgE content in chronic urticaria patients]. Zhen Ci Yan Jiu = Acupuncture Research/[Zhongguo Yi Xue Ke Xue Yuan Yi Xue Qing Bao Yan Jiu Suo Bian Ji] 2009; Vol. 34, issue 4:272‐5. [MEDLINE: ] - PubMed
Ge 1987 {published data only}
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- Ge ZP, Luo CH. The efficacy contrast between doxepin and cyproheptadine for chronic urticaria (Chinese). Journal of Clinical Dermatology 1987;16(5):242‐3.
Giannetti 1991 {published data only}
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- Giannetti A, Motolese A. Controlled clinical study of cetirizine versus astemizole in patients with idiopathic chronic urticaria [Studio clinico controllato ceririzina verso astemizolo in pazienti con orticaria cronica idiopatica]. Chronica Dermatologica 1991;1(3):321‐35. [EMBASE: 1991245329]
Gibson 1984 {published data only}
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- Gibson JR, Harvey SG, Barth JH, Moss MY, Burke CA. An assessment of the novel antihistamine BW 825C in the treatment of chronic idiopathic urticaria. A placebo‐controlled study. Dermatologica 1984; Vol. 169, issue 4:179‐83. [MEDLINE: ] - PubMed
Godse 2006 {published data only}
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- Godse KV. Oral montelukast monotherapy is ineffective in chronic idiopathic urticaria: a comparison with oral cetirizine. Indian Journal of Dermatology, Venereology & Leprology 2006;72(4):312‐4. [MEDLINE: ] - PubMed
Gong 1995 {published data only}
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- Gong J, Gao GB, Zhang W. Combined treatment with cetirizine, cimetidine and dipyridamole in 57 patients with chronic urticaria (Chinese). Journal of Clinical Dermatology 1995;24(3):163‐4.
Gonzalez‐Morales 1985 {published data only}
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- Gonzalez‐Morales JE, Leal De Hernandez L, Welsh O. Tolerance and efficacy of terfenadine compared with placebo in idiopathic chronic urticaria [Tolerancia y eficacia de la tefernadina contra placebo en el tratamiento de la urticaria cronica idiopatica. Estudio comparativo doble ciego.]. Dermatologia Revista Mexicana 1985;29(3):100‐4. [EMBASE: 1987098302]
Greaves 1981 {published data only}
Greene 1985 {published data only}
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- Greene SL, Reed CE, Schroeter AL. Double‐blind crossover study comparing doxepin with diphenhydramine for the treatment of chronic urticaria. Journal of the American Academy of Dermatology 1985;12(4):669‐75. [MEDLINE: ] - PubMed
Grob 2009 {published data only}
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- Grob JJ, Auquier P, Dreyfus I, Ortonne JP. How to prescribe antihistamines for chronic idiopathic urticaria: desloratadine daily vs PRN and quality of life. Allergy 2009;64(4):605‐12. [PUBMED: 19133920] - PubMed
Guaglianone 1988 {published data only}
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- Guaglianone MH, Vergallo G, Iudice A, Henauer S. Once a day dosage of terfenadine in chronic urticaria: a double‐blind comparison with the standard dosage. Arerugi [Allergy] 1988;43(Suppl 7):94.
Guerra 1994 {published data only}
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- Guerra L, Vincenzi C, Marchesi E, Tosti A, Pretto E, Bassi R, et al. Loratadine and cetirizine in the treatment of chronic urticaria. Journal of the European Academy of Dermatology & Venereology 1994;3(2):148‐52. [EMBASE: 1994126862]
Hair 2006 {published data only}
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- Hair PI, Scott LJ. Levocetirizine: a review of its use in the management of allergic rhinitis and skin allergies. Drugs 2006;66(7):973‐96. [MEDLINE: ] - PubMed
Hamerlinck 1994 {published data only}
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- Hamerlinck FFV, Boyden B, Oei HD, Niordson AM, Avrach W, Ottevanger V, et al. A double‐blind comparative study of loratadine and astemizole in chronic idiopathic urticaria. Journal of Dermatological Treatment 1994;5(4):199‐202. [EMBASE: 1995029316]
Hampel 2010 {published data only}
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- Hampel F, Nayak A, Texter M. The safety and tolerability of levocetirizine dihydrochloride in children 1‐5 years with allergic rhinitis or chronic idiopathic urticaria. Conference: Southwest Allergy Forum Puerto Vallarta Mexico. Conference Start: 20090114 Conference End: 20090118. Allergy & Asthma Proceedings 2009;30(2):209. [EMBASE: 70148899]
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- Hampel F, Ratner P, Haeusler JMC. Safety and tolerability of levocetirizine dihydrochloride in infants and children with allergic rhinitis or chronic urticaria. Allergy & Asthma Proceedings 2010;31(4):290‐5. [EMBASE: 2010482204] - PubMed
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- NCT00619801. A multi‐center, randomized, double blind, placebo controlled parallel group study of the safety of levocetirizine dihydrochloride oral liquid formulation b.i.d dosing in children aged 1 to < 6 years suffering from allergic rhinitis or chronic urticaria of unknown origin [completed]. clinicaltrials.gov/show/NCT00619801 (accessed 31 Jul 2008).
Han 1992 {published data only}
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- Han G, Ran LH. The curative effect observation of terfenadine for 116 cases hives (Chinese). Journal of Clinical Dermatology 1992;21(3):159.
Hong 2010 {published data only}
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- Hong JB, Lee HC, Hu FC, Chu CY. A randomized, double‐blind, active‐controlled, parallel‐group pilot study to compare the efficacy and sedative effects of desloratadine 5 mg with levocetirizine 5 mg in the treatment of chronic idiopathic urticaria. Journal of the American Academy of Dermatology 2010; Vol. 63, issue 5:e100‐2. [MEDLINE: ] - PubMed
Honsinger 1990 {published data only}
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- Honsinger RW Jr, Thomsen RJ. Prolonged benefit in the treatment of chronic idiopathic urticaria with astemizole. Annals of Allergy 1990;65(3):194‐200. [MEDLINE: ] - PubMed
Huo 2014 {published data only}
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- Huo HM. Efficacy observation on acupuncture combined with bloodletting for chronic urticaria. Zhongguo Zhenjiu = Chinese Acupuncture & Moxibustion 2014; Vol. 34, issue 1:41‐3. [MEDLINE: ] - PubMed
Ishibashi 1989 {published data only}
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- Ishibashi Y, Yoshida H, Kukita A, Harada S, Nishikawa T, Okawara A, et al. Dose finding study of astemizole (MJD‐30) on chronic urticaria [Astemizole (MJD‐30) no Mansei Jimmashin ni Okeru Shiteki Yoryo no Kento]. Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1989;5(12):2531‐43. [CENTRAL: CN‐00547587]
Ishibashi 1990 {published data only}
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- Ishibashi Y, Harada S, Niimura M, Ueda H, Imamura S, Yamamoto S, et al. Clinical evaluation of KG‐2413 (emedastine difumarate) on chronic urticaria by multicenter double‐blind study: comparative study between 2mg/day, 4mg/day, and ketotifen fumarate [Tashisetsu Niju Mokenho ni Yoru Mansei Jimmashin ni Taisuru Ko Arerugi Zai KG‐2413 (Fumarusan Emedasuchin) no Rinsho Hyoka: 2mg/Nichi, 4mg/Nichi Oyobi Fumarusan Ketoshifen ni Yoru 3 Gunkan Hikaku Seiseki]. Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1990;6(1):141‐59. [CENTRAL: CN‐00547345]
Ishibashi 1990a {published data only}
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- Ishibashi Y, Harada S, Kukita A, Nishikawa T, Yoshida H, Okawara A, et al. A clinical study of astemizole (MJD‐30) in treating chronic urticaria: a double blind, comparative study using ketotifen fumarate as a control drug [Astemizole (MJD‐30) no Mansei Jimmashin ni Taisuru Rinsho Shiken: Ketotifen Fumarate o Taishoyaku to Shita Niju Moken Hikaku Shiken]. Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1990;6(8):1623‐38. [CENTRAL: CN‐00547150]
Ishibashi 1990b {published data only}
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- Ishibashi Y, Harada S, Kukita A, Nishikawa T, Yoshida H, Okawara A, et al. A clinical study of astemizole (MJD‐30) in treating chronic urticaria: a double blind, comparative study using ketotifen fumarate as a control drug [Astemizole (MJD‐30) no Mansei Jimmashin ni Taisuru Rinsho Shiken: Ketotifen Fumarate o Taishoyaku to Shita Niju Moken Hikaku Shiken]. Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1990;6(8):1623‐38. [CENTRAL: CN‐00547150]
Ishibashi 1997 {published data only}
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- Ishibashi Y, Harada S, Niimura M, Kawashima M, Yamamoto S, Yoshida H, et al. A multicenter double‐blind comparative study: clinical evaluation of TAU‐284 (betotastine besilate) on chronic urticaria using terfenadine as a control drug [TAU‐284 (Beshirusan Betotasuchin) no Mansei Jimmashin ni Taisuru Rinsho Hyoka: Terufenajin o Taishoyaku to Shita Tashisetsu Niju Moken Hikaku Shiken]. Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1997;13(5):1287‐306. [CENTRAL: CN‐00547332]
Ishibashi 1997a {published data only}
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- Ishibashi, Y, Harada, S, Niimura, M. Early phase II study of TAU‐284 (betotastine besilate) on chronic urticaria [in Japanese]. Rinsho Iyaku 1997;13(5):1199‐215.
Ishibashi 1997b {published data only}
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- Ishibashi, Y, Harada, S, Niimura, M. Late phase II study of TAU‐284 (betotastine besilate) on chronic urticaria: optimal dose finding study by double‐blind technique [in Japanese]. Rinsho Iyaku 1997; Vol. 13, issue 5:1237‐57.
Isola 1985 {published data only}
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- Isola E, Rosengarten S, Torre F. Comparative multicenter study of the tolerance and efficacy of terfenadine vs placebo in chronic urticaria [Estudio multicentrico comparativo sobre tolerancia y eficacia de terfenadina vs. placebo en urticaria cronica]. Investigación Médica Internacional 1985;12(1):40‐8. [EMBASE: 1985205432]
Jauregui 2006 {published data only}
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- Jauregui I, Mullol J, Bartra J, Cuvillo A, Davila I, Montoro J, et al. H1antihistamines: psychomotor performance and driving. Journal of Investigational Allergology & Clinical Immunology 2006;16(Suppl 1):37‐44. [MEDLINE: ] - PubMed
Jia 1998 {published data only}
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- Jia H, Liu XQ, Li HZ, Lin L, Cao YH, Cui PG, et al. Clinical observation on the efficacy of domestic cetirizine in the treatment of urticaria (Chinese). Chinese Journal of Dermatology 1998;31(5):339.
Jolliffe 1985 {published data only}
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- Jolliffe DS, Sim‐Davis D, Templeton JS. A placebo‐controlled comparative study of sustained‐release brompheniramine maleate against clemastine fumarate in the treatment of chronic urticaria. Current Medical Research & Opinion 1985;9(6):394‐9. [MEDLINE: ] - PubMed
Juhlin 1988 {published data only}
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- Juhlin L, Arendt C. Treatment of chronic urticaria with cetirizine dihydrochloride, a non‐sedating antihistamine. British Journal of Dermatology 1988;119(1):67‐71. [MEDLINE: ] - PubMed
Jyothi 2011 {published data only}
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- Jyothi CH, Kiran LJ, Shashikala GH, Ravindra K, Santhosh R. Comparative study on safety and efficacy of loratadine, prednisolone & their combination in the treatment of chronic urticaria. Pharmacologyonline 2011;3:988‐96. [EMBASE: 2012087113]
Kailasam 1987 {published data only}
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- Kailasam V, Mathews KP. Controlled clinical assessment of astemizole in the treatment of chronic idiopathic urticaria and angioedema. Journal of the American Academy of Dermatology 1987; Vol. 16, issue 4:797‐804. [MEDLINE: ] - PubMed
Kalimo 1980 {published data only}
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- Kalimo K, Jansen CT. Treatment of chronic urticaria with an inhibitor of complement activation (cinnarizine). Annals of Allergy 1980;44(1):34‐7. [MEDLINE: ] - PubMed
Kalis 1985 {published data only}
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- Kalis B, Morel P, Prigent F. Chronic and cholinergic urticarias. Double blind comparison of mequitazine and hydroxyzine [Urticaires chroniques et cholinergiques. Etude comparative en double aveugle de la mequitazine et de l'hydroxyzine]. Medecine et Hygiene 1985;43(1604):1133‐6. [EMBASE: 1985098611]
Kalis 1996 {published data only}
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- Kalis B. Double‐blind multicentre comparative study of ebastine, terfenadine and placebo in the treatment of chronic idiopathic urticaria in adults. Drugs 1996;52(Suppl 1):30‐4. [MEDLINE: ] - PubMed
Kameyoshi 2007 {published data only}
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- Kameyoshi Y, Tanaka T, Mihara S, Takahagi S, Niimi N, Hide M. Increasing the dose of cetirizine may lead to better control of chronic idiopathic urticaria: an open study of 21 patients. British Journal of Dermatology 2007;157(4):803‐4. [MEDLINE: ] - PubMed
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Kawashima 2002 {published data only}
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Khalaf 2008 {published data only}
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- Khalaf AT, Liu XM, Sheng WX, Tan JQ, Abdalla AN. Efficacy and safety of desloratadine combined with dipyridamole in the treatment of chronic urticaria. Journal of the European Academy of Dermatology & Venereology 2008;22(4):487‐92. [MEDLINE: ] - PubMed
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Kukita 1990 {published data only}
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Kukita 1991 {published data only}
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Kukita 1994 {published data only}
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Kukita 1994a {published data only}
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Lambert 1993 {published data only}
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Neumann 1984 {published data only}
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Ormerod 1986 {published data only}
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Paul 1984 {published data only}
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- Yamada M, Ogino S, Horio T, Ikeda T. Effect of a new antihistamine 8599RP on chronic urticaria, with special reference to its comparison with d‐chlorpheniramine maleate. Acta Dermatologica‐Kyoto English Edition 1968;63(1):107‐11. [MEDLINE: ] - PubMed
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Zhang 1990 {published data only}
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Zhang 1991 {published data only}
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- Zhang HY, Zhang R, Ye ST. Multicenter, double‐blind trial of terfenadine in treatment of urticaria and allergic rhinitis in 384 patients. Chinese Journal of New Drugs & Clinical Remedies 1991;10(3):023. [CENTRAL: CN‐00715298]
Zhang 2001 {published data only}
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- Zhang HY, Li H, Yue FM, Wang LL. A multicenter, randomized, comparative study on the safety and efficacy of mizolastine versus loratadine for the treatment of chronic idiopathic urticaria. Chinese Journal of Microbiology & Immunology 2001;21(S:S):56‐9. [CENTRAL: CN‐00366969]
Zhao 1994 {published data only}
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- Zhao G, Zhang ZC. Clinical observation of the short‐term efficacy of loratadine in the treatment of chronic urticaria (Chinese). Chinese Journal of Dermatology 1994;27(1):65.
Zhi 2004 {published data only}
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- Zhi Y, Zhang H, Bi Z. A multicenter, double‐blind, randomized, parallel‐controlled study on the safety and efficacy of ebastine for the treatment of chronic idiopathic urticaria and allergic rhinitis. Jiangsu Medical Journal 2004;30(3):166‐8. [CENTRAL: CN‐00497534]
Zhou 2003 {published data only}
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Audi'cana 2007 {published data only}
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- Audı´cana MTLM, Marquina A, Bressieux, JMLF, Valiente R. A double‐blind, randomized, dose‐ranging trial in four parallel groups of 10, 20 and 30 mg bilastine once daily vs placebo in the symptomatic treatment of chronic idiopathic urticaria (CIU). Journal of Investigational Allergology & Clinical Immunology 2007;17(Suppl 3):77.
Blanca Gomez 1984 {published data only}
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Feng 2001 {published data only}
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- Feng J, Wang J, Yu B, Jia Q, Jin Z, Zhu W, et al. Observation of the efficacy of cetirizine in treatment of chronic and acute urticaria. Chinese Journal of New Drugs 2001;10(8):613‐4. [CENTRAL: CN‐00382803]
Guo 2013 {published data only}
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Guo 2014 {published data only}
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Hatano 1981 {published data only}
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- Hatano H, Harada T, Naka W, Hada S, Ishikawa K, Nagashima M, et al. A Double‐blind Controlled Study of Azatadine Maleate Tablet (Idulamine) on Urticaria and Pruritus Cutaneus. Rinsho Hyoka (Clinical Evaluation) 1981;9(2):461‐99. [CENTRAL: CN‐00268275]
Monroe 1992a {published data only}
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Okubo 2013 {published data only}
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- Okubo Y, Shigoka Y, Yamazaki M, Tsuboi R. Double dose of cetirizine hydrochloride is effective for patients with urticaria resistant: a prospective, randomized, non‐blinded, comparative clinical study and assessment of quality of life. Journal of Dermatological Treatment 2013; Vol. 24, issue 2:153‐60. [MEDLINE: ] - PubMed
Sil 2013 {published data only}
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Tanizaki 2013 {published data only}
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- Tanizaki H, Nakahigashi K, Miyachi Y, Kabashima K. Comparison of the efficacy of fexofenadine 120 and 240 mg/day on chronic idiopathic urticaria and histamine‐induced skin responses in Japanese populations. Journal of Dermatological Treatment 2013;24(6):477‐80. [EMBASE: 2013726806] - PubMed
Wang 2002 {published data only}
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Zhang 2012 {published data only}
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Zhang 2013 {published data only}
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- Zhang W, Xu XY, Wang N, Wu SY, Shi Y. Montelukast combined with cetirizine in the treatment of refractory urticaria: a clinical observation [Chinese]. Journal of Clinical Dermatology 2013;42(5):317‐8. [EMBASE: 2013442383]
Zhu 2012 {published data only}
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References to ongoing studies
CTRI/2014/04/004545 {unpublished data only}
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- CTRI/2014/04/004545. Comparison of efficacy, safety and cost effectiveness of rupatadine and olopatadine, anti‐histaminics, in patient of urticaria. www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8753 (accessed 2 June 2014).
EudraCT: 2004‐000771‐34 {unpublished data only}
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- EudraCT: 2004‐000771‐34. A 6‐week multicentre, double‐blind, randomised, placebo‐controlled, parallel‐group study to assess the efficacy and safety of rupatadine 10 and 20 mg in the treatment of chronic idiopathic urticaria (CIU): a phase III clinical trial. clinicaltrialsregister.eu/ctr‐search/search?query=eudract_number:2004‐00... (accessed 3 July 2013).
EudraCT: 2005‐002749‐38 {unpublished data only}
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- EudraCT: 2005‐002749‐38. A randomized, double‐blind, placebo‐controlled exploratory trial to evaluate a one‐week oral treatment with R129160 (60 mg o.d.) in patients with chronic idiopathic urticaria. clinicaltrialsregister.eu/ctr‐search/search?query=eudract_number:2005‐00... (accessed 3 July 2013).
JPRN‐UMIN000001163 {unpublished data only}
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JPRN‐UMIN000003290 {unpublished data only}
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- JPRN‐UMIN000003290. Study of the antipruritic effect and onset of sleepiness with oral antihistamines. //www.umin.ac.jp/ctr/index.htm (accessed 24 June 2014).
JPRN‐UMIN000008062 {unpublished data only}
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- JPRN‐UMIN000008062. A study evaluating efficacy of non‐sedative antihistamine up‐titration in patients with chronic urticaria who did not respond to standard therapy. www.umin.ac.jp/ctr/index.htm (accessed 24 June 2014).
JPRN‐UMIN000008461 {published data only}
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- JPRN‐UMIN000008461. A study on the optimal treatment for chronic idiopathic urticaria insufficient for the second‐generation antihistamines. www.umin.ac.jp/ctr/index.htm (accessed 24 June 2014).
JPRN‐UMIN000010265 {unpublished data only}
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- JPRN‐UMIN000010265. Preliminary trial of the increase of antihistamines in dose and a combination of different antihistamine on refractory spontaneous urticaria. www.umin.ac.jp/ctr/index.htm (accessed 24 June 2014).
NCT00199238 {unpublished data only}
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- NCT00199238. A 4‐week dose‐finding, multicentre, double‐blind, randomised, placebo‐controlled, parallel‐group trial to assess the efficacy and safety of different doses of rupatadine compared to placebo in the treatment of chronic idiopathic urticaria [Efficacy of rupatadine 5, 10 and 20 mg in chronic idiopathic urticaria]. ClinicalTrials.gov/show/NCT00199238 (accessed 3 July 2013).
NCT00199251 {unpublished data only}
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NCT00421109 {unpublished data only}
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- EudraCT: 2006‐001245‐33. Double‐blind, randomised, placebo‐controlled, phase III study comparing the efficacy and safety of bilastine 20 mg once daily and levocetirizine 5 mg for the treatment of chronic idiopathic urticaria [Estudio en fase III, doble ciego, randomizado, controlado con placebo, comparativo de la eficacia y seguridad de bilastina 20 mg una vez al día y levocetirizina 5 mg para el tratamiento de la urticaria crónica idiopática”]. clinicaltrialsregister.eu/ctr‐search/search?query=eudract_number:2006‐00... (accessed 3 July 2013).
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- NCT00421109. Efficacy study for the symptomatic treatment of chronic idiopathic urticaria. ClinicalTrials.gov/show/NCT00421109 (accessed 3 July 2013).
NCT00751166 {unpublished data only}
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- NCT00751166. A comparative double‐blind, double‐dummy study of desloratadine (dl) 5 mg once daily, cetirizine 10 mg once daily, and placebo once daily in patients with chronic idiopathic urticaria (study p03736) (terminated). ClinicalTrials.gov/show/NCT00751166 (accessed 3 July 2013).
NCT00751218 {unpublished data only}
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- NCT00751218. A comparative double‐blind, double‐ dummy study of desloratadine (dl) 5 mg once daily, cetirizine 10 mg once daily, and placebo once daily in patients with chronic idiopathic urticaria (study p03735) (completed). ClinicalTrials.gov/show/NCT00751218 (accessed 3 July 2013).
NCT00783354 {unpublished data only}
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- NCT00783354. A comparison of Aerius continuous treatment versus Aerius prn for chronic idiopathic urticaria (study p03147)(completed). ClinicalTrials.gov/show/NCT00783354 (accessed 3 July 2013).
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