A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma

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.

Conditions

• Asthma

Interventions

DRUG

Revamilast

Tablet. Low dose, Once daily for 12 weeks

DRUG

Revamilast

Medium dose, Once daily for 12 weeks

DRUG

Revamilast

High dose, Once daily for 12 weeks

DRUG

Placebo

Placebo tablet in triple dummy format, Once daily for 12 weeks

Sponsors & Collaborators

• Glenmark Pharmaceuticals S.A.

  collaborator INDUSTRY

• Glenmark Pharmaceuticals Ltd. India

  lead INDUSTRY

Principal Investigators

• Dr Ballari Brahmachari · Glenmark Pharmaceuticals Ltd

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2013-04-30

Completion

2013-04-30

Countries

• Czechia
• India
• Poland
• Russia
• United Kingdom

Study Locations