Status:
COMPLETED
A Clinical Trial to Study the Effects of Revamilast in Patients With Chronic Persistent Asthma
Lead Sponsor:
Glenmark Pharmaceuticals Ltd. India
Collaborating Sponsors:
Glenmark Pharmaceuticals S.A.
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 clinicall...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT01436890
Start Date
October 1 2011
End Date
April 1 2013
Last Update
June 21 2013
Active Locations (42)
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1
HORNMED s.r.o.
Brno, Czechia
2
Sdružená pneumologická a anesteziologická ambulance
Jindřichův Hradec, Czechia
3
Private pulmonatory ambulance
Neratovice, Czechia
4
Vasavi Hospital and Research Centre
Hyderabad, Andhra Pradesh, India, 500009