A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
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.