A one-year double-blind placebo-controlled study of the efficacy and safety of almitrine bismesylate in hypoxic COLD patients. Monitoring progress status on 490 patients entered into the VIMS study before January 1st, 1984

Abstract

The aim of the VIMS group is to verify the efficacy and acceptability of almitrine bismesylate (ABM) taken orally in the treatment of chronic obstructive bronchitis, by an international long-term study, one year controlled against placebo. This study includes more than 800 out-patients in 70 centres in 12 countries. 490 patients entered the study before 1/1/84, after the first 9 months of the inclusion period. 60% of patients are treated in France, 20% in the U.K. and Ireland and 20% in Belgium, Denmark, Italy, Switzerland. Their mean FEV1 is 0.87 liters, their mean PaO2 is 57 mmHg. The study protocol foresees two control visits separated by a 3 week interval before entry into the study in order to verify the stability of the patients on the basis of clinical, spirometric and gazometric data; the variation in PaO2 is less than or equal to 6 mmHg in more than 90% of the patients. The severity of the disease is assessed by the existence of an hospitalisation during the year preceeding the study in 55% of the patients, the necessity of oxygenotherapy at home for at least 12hr/day in 1/3 of them. The treatment of the latter was attributed separately at random to seek in a prospective manner the interest of associating O2 and ABM. During the study, the mortality of the patients included is 6% and about 70% of the patients completed the study period. The survey of adverse reactions and reasons for treatment interruption is progressively established by close collaboration between the investigators and monitors, to comply with the directives of pharmacosurveillance for severe and polymedicated patients. The analysis of the results to be carried out at the end of the study after verification and correction by the investigators, should enable us to enhance our knowledge of the clinical and gazometric parameters in patients with chronic obstructive disease followed for one year and treated by conventional means (control group) and the activity of ABM in order to confirm its therapeutic value in the treatment of chronic obstructive bronchitis.