A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma
Asthma is a common, chronic inflammatory disease of the bronchial airways, with a reported prevalence in most industrialized countries of between 5 to 10 % of the adult population. Asthma is clinically characterized by repeated episodes of wheezing, breathlessness, chest tightness, and coughing; usually in the presence of variable airflow obstruction that is often reversible either spontaneously or with treatment (The Global Initiative for Asthma (GINA), 2009).
Drug treatment of asthma has focused on anti-inflammatory therapy in all but the mildest, intermittent cases. Inhaled corticosteroids have been shown to be anti-inflammatory in asthma, but chronic use of these agents may be associated with a range of side effects, especially at high doses. In asthma, there remains a need for the development of novel anti-inflammatory therapies that are at least equally effective and possess a superior safety profile in comparison to corticosteroids.
This is a randomized, double-blind, triple dummy, placebo controlled, parallel group, dose ranging study. The study will be conducted in adult patients with a diagnosis of chronic persistent asthma with an Forced Expiratory Volume in one second(FEV1) of 50% to 80% of the predicted value. Study will enroll 448 patients globally (278 from India) across different centers.
Patients will be recruited after providing written informed consent. After screening and run in period, patient will be randomized (patient meeting randomization criteria) in 1:1:1:1 ratio to receive either one of the three dose regimens of revamilast or placebo.
The primary objective of the study is to evaluate the effect of revamilast on lung function as assessed by Forced Expiratory Volume in one second (FEV1) after the therapy (12 weeks). Secondary objective includes area under curve for FEV1, Change in asthma symptoms, patient / investigator's global assessments and safety. Patients will be followed for safety and efficacy assessment at week 1, 4, 8 12 and 14 after start of therapy.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase II, 12-week Randomized, Double-blind, Triple Dummy, Parallel Group, Placebo-controlled, Dose Range Finding Study to Evaluate Safety, Tolerability and Efficacy of Revamilast in Patients With Chronic Persistent Asthma|
- Change in Forced Expiratory Volume in One Second (FEV1) from baseline to week 12 [ Time Frame: Baseline to 12 weeks ]
- Change in morning pre-dose Forced Vital Capacity (FVC) from baseline to week 12 [ Time Frame: baseline to 12 weeks ]
- Area under the curve of Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 12 weeks ]
- Change in asthma day time symptom score from baseline to week 12 [ Time Frame: Baseline to 12 weeks ]
- Frequency and severity of asthma exacerbations during treatment period [ Time Frame: 12 weeks ]
- Change in investigator global impression from baseline to week 12 [ Time Frame: Baseline to 12 weeks ]An investigator-rated test measured on a 7-point scale, used to rate change in a patient's condition over the course of the study.
- Change in patient global impression from baseline to week 12 [ Time Frame: Baseline to 12 weeks ]A patient-rated test measured on a 7-point scale, used to rate change in a patient's condition over the course of the study.
- Change in morning pre-dose Peak Expiratory Flow (PEF) from baseline to week 12 [ Time Frame: Baseline to 12 weeks ]
- Change in morning pre-dose PEF25-75% (Forced expiratory flow 25-75%) from baseline to week 12 [ Time Frame: Baseline to 12 weeks ]
|Study Start Date:||October 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Low dose
Low dose revamilast
Tablet. Low dose, Once daily for 12 weeks
Experimental: Medium dose
Medium dose Revamilast
Medium dose, Once daily for 12 weeks
Experimental: High dose
High dose Revamilast
High dose, Once daily for 12 weeks
Placebo Comparator: Placebo
Matching placebo in triple dummy format
Placebo tablet in triple dummy format, Once daily for 12 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436890
Show 42 Study Locations
|Study Director:||Dr Ballari Brahmachari||Glenmark Pharmaceuticals Ltd|