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Clinical Trial
. 2001 Nov;87(5):379-85.
doi: 10.1016/S1081-1206(10)62918-3.

Suppression of hypothalamic-pituitary-adrenal axis activity with inhaled flunisolide and fluticasone propionate in adult asthma patients

T B Casale  1 , H S Nelson, W E Stricker, H Raff, K B Newman
Affiliations
Clinical Trial

Suppression of hypothalamic-pituitary-adrenal axis activity with inhaled flunisolide and fluticasone propionate in adult asthma patients

T B Casale et al. Ann Allergy Asthma Immunol. 2001 Nov.

Abstract

Background: Suppression of the hypothalamic-pituitary-adrenal (HPA) axis, a potential systemic effect of inhaled corticosteroid therapy, can be quantified by monitoring serum, urinary, and salivary cortisol levels.

Objectives: 1) Compare the effects on HPA axis of the inhaled corticosteroids flunisolide and fluticasone propionate versus placebo and oral prednisone. 2) Estimate dose-potency ratio for HPA-axis suppression.

Methods: Multicenter, randomized, placebo-controlled, open-label, 21-day trial. Active regimens were flunisolide 500 and 1,000 microg, twice daily; fluticasone propionate 110, 220, 330, and 440 microg, twice daily; and prednisone, 7.5 mg daily. Enrolled patients were nonsmokers, 18 to 50 years of age, with persistent mild-to-moderate asthma and had not used oral, nasal, or inhaled corticosteroids for 6 months before study. Main outcome measures were area under serum cortisol concentration curve for 22 hours (AUC(0-22h)); 24-hour urinary cortisol level; and 8 AM salivary cortisol level.

Results: One hundred fifty-three patients were randomly assigned to active treatment or placebo; 125 patients completed the study and were at least 80% compliant with their regimens. Both fluticasone propionate and flunisolide caused dose-dependent suppression of HPA axis, which was statistically greater for fluticasone propionate (P = 0.0003). Dose-potency ratio showed 4.4 times more serum-cortisol suppression/microgram increase in dose with fluticasone propionate than with flunisolide. Diurnal pattern of serum cortisol suppression was persistent with fluticasone propionate and "remitting" with flunisolide. Salivary and urinary cortisol data were qualitatively similar to serum cortisol results.

Conclusions: Fluticasone caused significantly more suppression of HPA axis than flunisolide. Flunisolide may provide a safe option for patients with asthma requiring long-term inhaled corticosteroid therapy.

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Comment in

  • Adrenal suppression with inhaled corticosteroids.
    Lipworth BJ. Lipworth BJ. Ann Allergy Asthma Immunol. 2001 Nov;87(5):359-61. doi: 10.1016/S1081-1206(10)62914-6. Ann Allergy Asthma Immunol. 2001. PMID: 11730176 No abstract available.
  • Inhaled fluticasone in asthmatic children.
    Pescollderungg L, Radetti G, Gottardi E, Gentili L, Pietrobelli A, Boner AL. Pescollderungg L, et al. Ann Allergy Asthma Immunol. 2002 Sep;89(3):328-9; author reply 329. doi: 10.1016/S1081-1206(10)61967-9. Ann Allergy Asthma Immunol. 2002. PMID: 12269658 No abstract available.
  • "Oversteroidization" of asthmatic patients.
    Garramone SM. Garramone SM. Ann Allergy Asthma Immunol. 2002 Sep;89(3):328; author reply 329. doi: 10.1016/S1081-1206(10)61966-7. Ann Allergy Asthma Immunol. 2002. PMID: 12269659 No abstract available.

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