Health Condition 1: null- Chronic Persistent Asthma
Conditions
Interventions
Low dose revamilast for 12 weeks
Intervention2: Revamilast: Oral
Mediun dose revamilast for 12 weeks
Intervention3: Revamilast: Oral
High dose revamilast for 12 weeks
Control Intervention1: Placebo: Matching placebo in triple dummy format
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Female subjects on hormone replacement therapy or hormonal contraceptives 3. Suffering from relevant lung diseases (other than asthma) causing impairment in lung function 4. Past smoker with a history of ¡Ý10 pack per year or current smoker 5. Recent change in the patient¡¯s usual asthma treatment 6. Patients with risk factors for asthma exacerbation during the study, including (any of the following): a. Current requirement for 8 puffs per day of reliever medication. b. Hospitalization for asthma c. Treatment with systemic corticosteroid therapy within 3 months 7. Evidence of current or recent neoplastic disease 8. Clinically significant cardiovascular, haematological, endocrine, neurological, gastrointestinal, psychiatric, metabolic, immunologic, infectious, hepatic, renal, gynaecological disease or other condition that the investigator considers detrimental to the patient¡¯s participation in the study or that may prevent the successful completion of the study 9. Positive serology for an infectious disease (including hepatitis B or C) at screening and known case of human immunodeficiency virus [HIV] 10. Patients who have been hospitalized for any psychiatric illness in the past year, or are diagnosed with major depression 11. Clinically significant ECG Abnormality at baseline 12. Patients with documented or suspected or current history of alcohol and drug abuse 13. Patients who have undergone lung surgery in the previous year 14. Participation in an investigational drug trial during 30 days preceding screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FEV1 from baseline to end of therapyTimepoint: 84 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve of change from baseline FEV1 measured at each visitTimepoint: 84 days;Change in asthma day time symptom scoreTimepoint: 84 days;Change in morning pre-dose FVC, PEF,FEF25-75%Timepoint: 84 days;Frequency and severity of asthma exacerbationsTimepoint: 84 days;Investigator global impressionTimepoint: 84 days;Patient global impressionTimepoint: 84 days | — |
Countries
Czech Republic, India, Poland, Russian Federation, United Kingdom
Contacts
Public ContactDr Shailendra Sachan
Glenmark Pharmaceuticals Ltd
Outcome results
None listed