AsthmaPhase 2NCT01436890
A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma
A Phase 2 study testing Revamilast in people with Asthma, run by Glenmark Pharmaceuticals Ltd. India at 42 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Revamilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 42 sitesin 5 countries
- Study dates
- Oct 2011to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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):
Show all 17Show fewer
- 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
Trial locations and contacts
42 sites in 5 countries.
42 sites in 5 countries
India26 sites
Gujarat Pulmonary & Critical Care Clinic
Ahmedabad, Gujarat
Chest and Maternity Centre
Bangalore, Karnataka
M S Ramaiah Medical College & Teaching Hospital
Bangalore, Karnataka
Narayanan Hrudayalaya Hospital
Bangalore, Karnataka
Chennai Thoracic Research Institute
Chennai, Tamil Nadu
Vasavi Hospital and Research Centre
Hyderabad, Andhra Pradesh, 500009
Saboo hospital and research centre
Hyderabad, Andhra Pradesh, 500012
Kunal Institute of Medical Specialities Pvt. Ltd
Hyderabad, Andhra Pradesh
Indore Chest Centre
Indore, Madhya Pradesh, 452001
Shwaas Center, Navkar Hospital
Jaipur, Rajasthan, 302023
Asthma Bhawan
Jaipur, Rajasthan
Dr Khippal's Clinic
Jaipur, Rajasthan
National Allergy Asthma Bronchitis Institute
Kolkata, West Bengal
Kasturba Medical College Hospital
Mangalore, Karnataka
T B and Chest Disease Hospital
Mormugao, Goa
Prince Aly Khan Hospital
Mumbai, Maharashtra, 400010
The Bhatia Hospital
Mumbai, Maharashtra
KRIMS Hospitals
Nagpur, Maharashtra, 440010
Getwell Hospital & Research Institute
Nagpur, Maharashtra, 440015
Narayana Medical College & Hospital
Nellore, Andhra Pradesh
MAMC & Associated Lok Nayak Hospitals
New Delhi, New Delhi, 110002
Rutuja Allergy , Chest and General Clinic
Ponda, Goa
Chest Research Foundation
Pune, Maharashtra
Yashoda Hospital
Secunderabad, Andhra Pradesh
Westfort Hi-tech Hospital Ltd
Thrissur, Kerala
Christian Medical College
Vellore, Tamil Nadu
Poland8 sites
NZOZ 'Promedica'
Bialystok
Nzoz Clinica Vitae
Gdansk
Landa Specjalistyczne Gabinety Lekarskie
Krakow
Prywatna Praktyka Lekarska
Krakow
Prywatny Gabinet Specjalistyczny
Lodz
Cdt Medicus
Lubin
Centrum Alergologii Teresa Hofman
Poznan
Centrum Medyczne Lucyna Andrzej Dymek
Strzelce Opolskie
Russia4 sites
State Healthcare Institution
Elektrostal
Central Clinical Hospital of Russian Academy of Science
Moscow
State Healthcare Institution of Moscow
Moscow
State Educational Healthcare Institution
Saratov
Czechia3 sites
HORNMED s.r.o.
Brno
Sdružená pneumologická a anesteziologická ambulance
Jindřichův Hradec
Private pulmonatory ambulance
Neratovice
United Kingdom1 site
London Chest Hospital Department of Respiratory Medicine
London, UK
About this study
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
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.
Read more
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
- Being tested
- Revamilast, Placebo
- Keywords
- Chronic Persistent Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevamilastDrug
Tablet. Low dose, Once daily for 12 weeks
RevamilastDrug
Medium dose, Once daily for 12 weeks
RevamilastDrug
High dose, Once daily for 12 weeks
PlaceboDrug
Placebo tablet in triple dummy format, Once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Low dose revamilast Receives: Drug: Revamilast |
| Medium dose | Experimental | Medium dose Revamilast Receives: Drug: Revamilast |
| High dose | Experimental | High dose Revamilast Receives: Drug: Revamilast |
| Placebo | Placebo comparator | Matching placebo in triple dummy format Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in One Second (FEV1) from baseline to week 12
Measured: Baseline to 12 weeks
Secondary outcomes (8)
Change in morning pre-dose Forced Vital Capacity (FVC) from baseline to week 12
Measured: baseline to 12 weeks
Area under the curve of Forced Expiratory Volume in One Second (FEV1)
Measured: 12 weeks
Change in asthma day time symptom score from baseline to week 12
Measured: Baseline to 12 weeks
Frequency and severity of asthma exacerbations during treatment period
Measured: 12 weeks
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.
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
Change in morning pre-dose Peak Expiratory Flow (PEF) from baseline to week 12
Measured: Baseline to 12 weeks
Change in morning pre-dose PEF25-75% (Forced expiratory flow 25-75%) from baseline to week 12
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Responsible party
- Sponsor
- Investigators
- Dr Ballari Brahmachari, Study director, Glenmark Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436890
- Sponsor's protocol ID
- GRC 4039-204
- Other IDs
- 2011-000270-57
- Status last verified
- Jun 2013
- First submitted
- 14 Sep 2011
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01436890
- Acronym / sponsor ID
- GRC 4039-204
- Conditions
- Asthma
- Keywords
- Chronic Persistent Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: RevamilastLow dose revamilast |
| Medium dose | Experimental | Drug: RevamilastMedium dose Revamilast |
| High dose | Experimental | Drug: RevamilastHigh dose Revamilast |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo in triple dummy format |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RevamilastTablet. Low dose, Once daily for 12 weeks | Drug | Low dose |
| RevamilastMedium dose, Once daily for 12 weeks | Drug | Medium dose |
| RevamilastHigh dose, Once daily for 12 weeks | Drug | High dose |
| PlaceboPlacebo tablet in triple dummy format, Once daily for 12 weeks | Drug | Placebo |
Primary outcome
Change in Forced Expiratory Volume in One Second (FEV1) from baseline to week 12
Time frame: Baseline to 12 weeks
8 secondary outcomes
Change in morning pre-dose Forced Vital Capacity (FVC) from baseline to week 12
Time frame: baseline to 12 weeks
Area under the curve of Forced Expiratory Volume in One Second (FEV1)
Time frame: 12 weeks
Change in asthma day time symptom score from baseline to week 12
Time frame: Baseline to 12 weeks
Frequency and severity of asthma exacerbations during treatment period
Time frame: 12 weeks
Change in investigator global impression from baseline to week 12
Time frame: Baseline to 12 weeks
Change in patient global impression from baseline to week 12
Time frame: Baseline to 12 weeks
Change in morning pre-dose Peak Expiratory Flow (PEF) from baseline to week 12
Time frame: Baseline to 12 weeks
Change in morning pre-dose PEF25-75% (Forced expiratory flow 25-75%) from baseline to week 12
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Ballari Brahmachari study director
Glenmark Pharmaceuticals Ltd
42 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Revamilast in people with Asthma, run by Glenmark Pharmaceuticals Ltd. India at 42 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in India, Poland, Russia, Czechia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Expiratory Volume in One Second (FEV1) from baseline to week 12 (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.