A clinical trial to study the effects of Revamilast in patients with Chronic Persistent Asthma

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2011
INTERVENTION: Intervention1: Revamilast: Oral; Once a day; Low dose revamilast for 12 weeks Intervention2: Revamilast: Oral; Once a day; Mediun dose revamilast for 12 weeks Intervention3: Revamilast: Oral; Once a day; High dose revamilast for 12 weeks Control Intervention1: Placebo: Matching placebo in triple dummy format CONDITION: Chronic Persistent Asthma PRIMARY OUTCOME: Change in FEV1 from baseline to end of therapy‐‐‐‐‐‐Timepoint: 84 days SECONDARY OUTCOME: Area under the curve of change from baseline FEV1 measured at each visit‐‐‐‐‐‐Timepoint: 84 days Change in asthma day time symptom score‐‐‐‐‐‐Timepoint: 84 days Change in morning pre‐dose FVC, PEF,FEF25‐75%‐‐‐‐‐‐Timepoint: 84 days Frequency and severity of asthma exacerbations‐‐‐‐‐‐Timepoint: 84 days Investigator global impression‐‐‐‐‐‐Timepoint: 84 days Patient global impression‐‐‐‐‐‐Timepoint: 84 days INCLUSION CRITERIA: 1. The patient provides written informed consent to participate in the study 2. Male or female patient aged 18 to 65 years 3. Documented diagnosis of asthma 4. FEV1 between 50% and 80% of the predicted value 5. Patient judged by the investigator to be in otherwise good stable health based on medical history, physical examination, and routine laboratory data 6. Female participants must have a negative pregnancy test at screening visit 7. Males must agree to use barrier contraception while on study medication and for 90 days after taking the last dose of study medication
Epistemonikos ID: b6e2af6e73344ec985d848e8ddb64efceabb4005
First added on: Aug 22, 2024