Back to resultsA Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Revamilast
Revamilast
Revamilast
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Chronic Persistent Asthma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Patients who have undergone lung surgery in the previous year
- Participation in an investigational drug trial during 30 days preceding screening
Sites / Locations
- HORNMED s.r.o.
- Sdružená pneumologická a anesteziologická ambulance
- Private pulmonatory ambulance
- Kunal Institute of Medical Specialities Pvt. Ltd
- Narayana Medical College & Hospital
- Yashoda Hospital
- Vasavi Hospital and Research Centre
- Saboo hospital and research centre
- Rutuja Allergy , Chest and General Clinic
- Gujarat Pulmonary & Critical Care Clinic
- Chest and Maternity Centre
- M S Ramaiah Medical College & Teaching Hospital
- Narayanan Hrudayalaya Hospital
- Kasturba Medical College Hospital
- Westfort Hi-tech Hospital Ltd
- Indore Chest Centre
- Prince Aly Khan Hospital
- The Bhatia Hospital
- KRIMS Hospitals
- Getwell Hospital & Research Institute
- Chest Research Foundation
- Shwaas Center, Navkar Hospital
- Asthma Bhawan
- Dr Khippal's Clinic
- Chennai Thoracic Research Institute
- Christian Medical College
- National Allergy Asthma Bronchitis Institute
- T B and Chest Disease Hospital
- MAMC & Associated Lok Nayak Hospitals
- NZOZ 'Promedica'
- Nzoz Clinica Vitae
- Landa Specjalistyczne Gabinety Lekarskie
- Prywatna Praktyka Lekarska
- Prywatny Gabinet Specjalistyczny
- Cdt Medicus
- Centrum Alergologii Teresa Hofman
- Centrum Medyczne Lucyna Andrzej Dymek
- State Healthcare Institution
- Central Clinical Hospital of Russian Academy of Science
- State Healthcare Institution of Moscow
- State Educational Healthcare Institution
- London Chest Hospital Department of Respiratory Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Low dose
Medium dose
High dose
Placebo
Arm Description
Low dose revamilast
Medium dose Revamilast
High dose Revamilast
Matching placebo in triple dummy format
Outcomes
Primary Outcome Measures
Change in Forced Expiratory Volume in One Second (FEV1) from baseline to week 12
Secondary Outcome Measures
Change in morning pre-dose Forced Vital Capacity (FVC) from baseline to week 12
Area under the curve of Forced Expiratory Volume in One Second (FEV1)
Change in asthma day time symptom score from baseline to week 12
Frequency and severity of asthma exacerbations during treatment period
Change in investigator global impression from baseline to week 12
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.
Change in patient global impression from baseline to week 12
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.
Change in morning pre-dose Peak Expiratory Flow (PEF) from baseline to week 12
Change in morning pre-dose PEF25-75% (Forced expiratory flow 25-75%) from baseline to week 12
Full Information
NCT ID
NCT01436890
First Posted
September 14, 2011
Last Updated
June 20, 2013
Sponsor
Glenmark Pharmaceuticals Ltd. India
Collaborators
Glenmark Pharmaceuticals S.A.
1. Study Identification
Unique Protocol Identification Number
NCT01436890
Brief Title
A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma
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 Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glenmark Pharmaceuticals Ltd. India
Collaborators
Glenmark Pharmaceuticals S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Chronic Persistent Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose
Arm Type
Experimental
Arm Description
Low dose revamilast
Arm Title
Medium dose
Arm Type
Experimental
Arm Description
Medium dose Revamilast
Arm Title
High dose
Arm Type
Experimental
Arm Description
High dose Revamilast
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo in triple dummy format
Intervention Type
Drug
Intervention Name(s)
Revamilast
Intervention Description
Tablet. Low dose, Once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Revamilast
Intervention Description
Medium dose, Once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Revamilast
Intervention Description
High dose, Once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet in triple dummy format, Once daily for 12 weeks
Primary Outcome Measure Information:
Title
Change in Forced Expiratory Volume in One Second (FEV1) from baseline to week 12
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in morning pre-dose Forced Vital Capacity (FVC) from baseline to week 12
Time Frame
baseline to 12 weeks
Title
Area under the curve of Forced Expiratory Volume in One Second (FEV1)
Time Frame
12 weeks
Title
Change in asthma day time symptom score from baseline to week 12
Time Frame
Baseline to 12 weeks
Title
Frequency and severity of asthma exacerbations during treatment period
Time Frame
12 weeks
Title
Change in investigator global impression from baseline to week 12
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change in patient global impression from baseline to week 12
Description
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.
Time Frame
Baseline to 12 weeks
Title
Change in morning pre-dose Peak Expiratory Flow (PEF) from baseline to week 12
Time Frame
Baseline to 12 weeks
Title
Change in morning pre-dose PEF25-75% (Forced expiratory flow 25-75%) from baseline to week 12
Time Frame
Baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Patients who have undergone lung surgery in the previous year
Participation in an investigational drug trial during 30 days preceding screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Ballari Brahmachari
Organizational Affiliation
Glenmark Pharmaceuticals Ltd
Official's Role
Study Director
Facility Information:
Facility Name
HORNMED s.r.o.
City
Brno
Country
Czech Republic
Facility Name
Sdružená pneumologická a anesteziologická ambulance
City
Jindřichův Hradec
Country
Czech Republic
Facility Name
Private pulmonatory ambulance
City
Neratovice
Country
Czech Republic
Facility Name
Kunal Institute of Medical Specialities Pvt. Ltd
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Narayana Medical College & Hospital
City
Nellore
State/Province
Andhra Pradesh
Country
India
Facility Name
Yashoda Hospital
City
Secunderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Vasavi Hospital and Research Centre
City
Hyderabad
State/Province
Andra Pradesh
ZIP/Postal Code
500009
Country
India
Facility Name
Saboo hospital and research centre
City
Hyderabad
State/Province
Andra Pradesh
ZIP/Postal Code
500012
Country
India
Facility Name
Rutuja Allergy , Chest and General Clinic
City
Ponda
State/Province
Goa
Country
India
Facility Name
Gujarat Pulmonary & Critical Care Clinic
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Chest and Maternity Centre
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
M S Ramaiah Medical College & Teaching Hospital
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Narayanan Hrudayalaya Hospital
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Kasturba Medical College Hospital
City
Mangalore
State/Province
Karnataka
Country
India
Facility Name
Westfort Hi-tech Hospital Ltd
City
Thrissur
State/Province
Kerala
Country
India
Facility Name
Indore Chest Centre
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452001
Country
India
Facility Name
Prince Aly Khan Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400010
Country
India
Facility Name
The Bhatia Hospital
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
KRIMS Hospitals
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Getwell Hospital & Research Institute
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440015
Country
India
Facility Name
Chest Research Foundation
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Shwaas Center, Navkar Hospital
City
Jaipur
State/Province
Rajastan
ZIP/Postal Code
302023
Country
India
Facility Name
Asthma Bhawan
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
Dr Khippal's Clinic
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
Chennai Thoracic Research Institute
City
Chennai
State/Province
Tamil Nadu
Country
India
Facility Name
Christian Medical College
City
Vellore
State/Province
Tamil Nadu
Country
India
Facility Name
National Allergy Asthma Bronchitis Institute
City
Kolkata
State/Province
West Bengal
Country
India
Facility Name
T B and Chest Disease Hospital
City
Goa
Country
India
Facility Name
MAMC & Associated Lok Nayak Hospitals
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
NZOZ 'Promedica'
City
Bialystok
Country
Poland
Facility Name
Nzoz Clinica Vitae
City
Gdansk
Country
Poland
Facility Name
Landa Specjalistyczne Gabinety Lekarskie
City
Krakow
Country
Poland
Facility Name
Prywatna Praktyka Lekarska
City
Krakow
Country
Poland
Facility Name
Prywatny Gabinet Specjalistyczny
City
Lodz
Country
Poland
Facility Name
Cdt Medicus
City
Lubin
Country
Poland
Facility Name
Centrum Alergologii Teresa Hofman
City
Poznan
Country
Poland
Facility Name
Centrum Medyczne Lucyna Andrzej Dymek
City
Strzelce Opolskie
Country
Poland
Facility Name
State Healthcare Institution
City
Elektrostal
Country
Russian Federation
Facility Name
Central Clinical Hospital of Russian Academy of Science
City
Moscow
Country
Russian Federation
Facility Name
State Healthcare Institution of Moscow
City
Moscow
Country
Russian Federation
Facility Name
State Educational Healthcare Institution
City
Saratov
Country
Russian Federation
Facility Name
London Chest Hospital Department of Respiratory Medicine
City
London
State/Province
UK
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma
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