A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma
NCT ID: NCT01436890
Last Updated: 2013-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
273 participants
INTERVENTIONAL
2011-10-31
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Study of Oglemilast in Patients With Mild to Moderate Persistent Asthma
NCT00859404
A Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics
NCT00150397
Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma
NCT00425061
Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
NCT00670930
A Study of MK0359 in Patients With Chronic Asthma (0359-013)
NCT00482898
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low dose
Low dose revamilast
Revamilast
Tablet. Low dose, Once daily for 12 weeks
Medium dose
Medium dose Revamilast
Revamilast
Medium dose, Once daily for 12 weeks
High dose
High dose Revamilast
Revamilast
High dose, Once daily for 12 weeks
Placebo
Matching placebo in triple dummy format
Placebo
Placebo tablet in triple dummy format, Once daily for 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Revamilast
Tablet. Low dose, Once daily for 12 weeks
Revamilast
Medium dose, Once daily for 12 weeks
Revamilast
High dose, Once daily for 12 weeks
Placebo
Placebo tablet in triple dummy format, Once daily for 12 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Glenmark Pharmaceuticals S.A.
INDUSTRY
Glenmark Pharmaceuticals Ltd. India
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr Ballari Brahmachari
Role: STUDY_DIRECTOR
Glenmark Pharmaceuticals Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HORNMED s.r.o.
Brno, , Czechia
Sdružená pneumologická a anesteziologická ambulance
Jindřichův Hradec, , Czechia
Private pulmonatory ambulance
Neratovice, , Czechia
Vasavi Hospital and Research Centre
Hyderabad, Andhra Pradesh, India
Saboo hospital and research centre
Hyderabad, Andhra Pradesh, India
Kunal Institute of Medical Specialities Pvt. Ltd
Hyderabad, Andhra Pradesh, India
Narayana Medical College & Hospital
Nellore, Andhra Pradesh, India
Yashoda Hospital
Secunderabad, Andhra Pradesh, India
T B and Chest Disease Hospital
Mormugao, Goa, India
Rutuja Allergy , Chest and General Clinic
Ponda, Goa, India
Gujarat Pulmonary & Critical Care Clinic
Ahmedabad, Gujarat, India
Chest and Maternity Centre
Bangalore, Karnataka, India
M S Ramaiah Medical College & Teaching Hospital
Bangalore, Karnataka, India
Narayanan Hrudayalaya Hospital
Bangalore, Karnataka, India
Kasturba Medical College Hospital
Mangalore, Karnataka, India
Westfort Hi-tech Hospital Ltd
Thrissur, Kerala, India
Indore Chest Centre
Indore, Madhya Pradesh, India
Prince Aly Khan Hospital
Mumbai, Maharashtra, India
The Bhatia Hospital
Mumbai, Maharashtra, India
KRIMS Hospitals
Nagpur, Maharashtra, India
Getwell Hospital & Research Institute
Nagpur, Maharashtra, India
Chest Research Foundation
Pune, Maharashtra, India
MAMC & Associated Lok Nayak Hospitals
New Delhi, New Delhi, India
Shwaas Center, Navkar Hospital
Jaipur, Rajasthan, India
Asthma Bhawan
Jaipur, Rajasthan, India
Dr Khippal's Clinic
Jaipur, Rajasthan, India
Chennai Thoracic Research Institute
Chennai, Tamil Nadu, India
Christian Medical College
Vellore, Tamil Nadu, India
National Allergy Asthma Bronchitis Institute
Kolkata, West Bengal, India
NZOZ 'Promedica'
Bialystok, , Poland
Nzoz Clinica Vitae
Gdansk, , Poland
Landa Specjalistyczne Gabinety Lekarskie
Krakow, , Poland
Prywatna Praktyka Lekarska
Krakow, , Poland
Prywatny Gabinet Specjalistyczny
Lodz, , Poland
Cdt Medicus
Lubin, , Poland
Centrum Alergologii Teresa Hofman
Poznan, , Poland
Centrum Medyczne Lucyna Andrzej Dymek
Strzelce Opolskie, , Poland
State Healthcare Institution
Elektrostal, , Russia
Central Clinical Hospital of Russian Academy of Science
Moscow, , Russia
State Healthcare Institution of Moscow
Moscow, , Russia
State Educational Healthcare Institution
Saratov, , Russia
London Chest Hospital Department of Respiratory Medicine
London, UK, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-000270-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GRC 4039-204
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.