A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma
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
2 other identifiers
interventional
273
5 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Oct 2011
Typical duration for phase_2 asthma
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2011
CompletedFirst Posted
Study publicly available on registry
September 20, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJune 21, 2013
June 1, 2013
1.5 years
September 14, 2011
June 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Forced Expiratory Volume in One Second (FEV1) from baseline to week 12
Baseline to 12 weeks
Secondary Outcomes (8)
Change in morning pre-dose Forced Vital Capacity (FVC) from baseline to week 12
baseline to 12 weeks
Area under the curve of Forced Expiratory Volume in One Second (FEV1)
12 weeks
Change in asthma day time symptom score from baseline to week 12
Baseline to 12 weeks
Frequency and severity of asthma exacerbations during treatment period
12 weeks
Change in investigator global impression from baseline to week 12
Baseline to 12 weeks
- +3 more secondary outcomes
Study Arms (4)
Low dose
EXPERIMENTALLow dose revamilast
Medium dose
EXPERIMENTALMedium dose Revamilast
High dose
EXPERIMENTALHigh dose Revamilast
Placebo
PLACEBO COMPARATORMatching placebo in triple dummy format
Interventions
Eligibility Criteria
You may qualify if:
- The patient provides written informed consent to participate in the study
- Male or female patient aged 18 to 65 years
- Documented diagnosis of asthma
- Forced Expiratory Volume in One Second (FEV1) between 50% and 80% of the predicted value
- Patient judged by the investigator to be in otherwise good stable health based on medical history, physical examination, and routine laboratory data
- Female participants must have a negative pregnancy test at screening visit
- Males must agree to use barrier contraception while on study medication and for 90 days after taking the last dose of study medication
You may not qualify if:
- Pregnant or lactating women
- Female subjects on hormone replacement therapy or hormonal contraceptives
- Suffering from relevant lung diseases (other than asthma) causing impairment in lung function
- Past smoker with a history of ≥10 pack per year or current smoker
- Recent change in the patient's usual asthma treatment
- 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
- Evidence of current or recent neoplastic disease
- 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
- Positive serology for an infectious disease (including hepatitis B or C) at screening and known case of human immunodeficiency virus \[HIV\]
- Patients who have been hospitalized for any psychiatric illness in the past year, or are diagnosed with major depression
- Clinically significant ECG Abnormality at baseline
- Patients with documented or suspected or current history of alcohol and drug abuse
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glenmark Pharmaceuticals Ltd. Indialead
- Glenmark Pharmaceuticals S.A.collaborator
Study Sites (42)
HORNMED s.r.o.
Brno, Czechia
SdruženĂ¡ pneumologickĂ¡ a anesteziologickĂ¡ ambulance
Jindřichův Hradec, Czechia
Private pulmonatory ambulance
Neratovice, Czechia
Vasavi Hospital and Research Centre
Hyderabad, Andhra Pradesh, 500009, India
Saboo hospital and research centre
Hyderabad, Andhra Pradesh, 500012, 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, 452001, India
Prince Aly Khan Hospital
Mumbai, Maharashtra, 400010, India
The Bhatia Hospital
Mumbai, Maharashtra, India
KRIMS Hospitals
Nagpur, Maharashtra, 440010, India
Getwell Hospital & Research Institute
Nagpur, Maharashtra, 440015, India
Chest Research Foundation
Pune, Maharashtra, India
MAMC & Associated Lok Nayak Hospitals
New Delhi, New Delhi, 110002, India
Shwaas Center, Navkar Hospital
Jaipur, Rajasthan, 302023, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr Ballari Brahmachari
Glenmark Pharmaceuticals Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2011
First Posted
September 20, 2011
Study Start
October 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
June 21, 2013
Record last verified: 2013-06