Vectarion International Multicentre Study (VIMS): a long term double blind placebo controlled trial in COLD patients

In a previous six month study almitrine bismesylate ( Vectarion ) administration has been shown to be effective and safe in the treatment of hypoxaemic and hypercapnic chronic obstructive pulmonary disease (COLD). The protocol of the present VIMS study has been designed to complete the evaluation of the clinical benefit obtained after oral almitrine bismesylate administration on a larger scale and over at least a one year period in hypoxaemic COLD patients. Male and female outpatients will be included with an age 35-75, weight 50-95 kg, PaO2 45-65 mmHg, PaCO2 35-60 mmHg, FEV1/FVC 30-65%. Patients with primarily restrictive pulmonary disease, with cardiac, renal, central nervous system or hepatic impairment, and female patients of child bearing potential, will be excluded. After a three week stabilization period, patients will enter the study and receive on a random basis either almitrine bismesylate or placebo with a stratified allocation within each centre and whether patients receive or not long term continuous domiciliary oxygen therapy. Clinical examination, arterial blood gases, dyspnoea score, 6 mn walking distance, pulmonary function tests, haematological, biochemical profiles and plasma levels will be measured on a quarterly basis and electrocardiogram at six monthly intervals. Hospitalizations, new signs and symptoms, and changes in concomitant treatment will be recorded at each visit. Administration of the drug will be 50 mg b.d. during the first three months with a possible increase of 50 mg after the third and/or the sixth month visits if, and only if, PaO2 increase is less than 5 mmHg and if the drug is well tolerated.(ABSTRACT TRUNCATED AT 250 WORDS)