COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01436890
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : June 21, 2013
Glenmark Pharmaceuticals S.A.
Information provided by (Responsible Party):
Glenmark Pharmaceuticals Ltd. India

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Revamilast Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : October 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Low dose
Low dose revamilast
Drug: Revamilast
Tablet. Low dose, Once daily for 12 weeks

Experimental: Medium dose
Medium dose Revamilast
Drug: Revamilast
Medium dose, Once daily for 12 weeks

Experimental: High dose
High dose Revamilast
Drug: Revamilast
High dose, Once daily for 12 weeks

Placebo Comparator: Placebo
Matching placebo in triple dummy format
Drug: Placebo
Placebo tablet in triple dummy format, Once daily for 12 weeks

Primary Outcome Measures :
  1. Change in Forced Expiratory Volume in One Second (FEV1) from baseline to week 12 [ Time Frame: Baseline to 12 weeks ]

Secondary Outcome Measures :
  1. Change in morning pre-dose Forced Vital Capacity (FVC) from baseline to week 12 [ Time Frame: baseline to 12 weeks ]
  2. Area under the curve of Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 12 weeks ]
  3. Change in asthma day time symptom score from baseline to week 12 [ Time Frame: Baseline to 12 weeks ]
  4. Frequency and severity of asthma exacerbations during treatment period [ Time Frame: 12 weeks ]
  5. 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.

  6. 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.

  7. Change in morning pre-dose Peak Expiratory Flow (PEF) from baseline to week 12 [ Time Frame: Baseline to 12 weeks ]
  8. Change in morning pre-dose PEF25-75% (Forced expiratory flow 25-75%) from baseline to week 12 [ Time Frame: Baseline to 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. Forced Expiratory Volume in One Second (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:

  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 ≥10 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):

    • Current requirement for > 8 puffs per day of reliever medication.
    • Hospitalization for asthma
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01436890

Show Show 42 study locations
Sponsors and Collaborators
Glenmark Pharmaceuticals Ltd. India
Glenmark Pharmaceuticals S.A.
Layout table for investigator information
Study Director: Dr Ballari Brahmachari Glenmark Pharmaceuticals Ltd

Layout table for additonal information
Responsible Party: Glenmark Pharmaceuticals Ltd. India Identifier: NCT01436890    
Other Study ID Numbers: GRC 4039-204
2011-000270-57 ( EudraCT Number )
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by Glenmark Pharmaceuticals Ltd. India:
Chronic Persistent Asthma
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases