A clinical trial to study the effects of Beclomethasone in patients with Asthma
- Conditions
- Health Condition 1: null- Asthma
- Registration Number
- CTRI/2011/11/002176
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 280
1. Male or female patient aged between 18 to 70 years with clinical diagnosis of mild to moderate asthma
2. The patient provides written informed consent to participate in the study
3. FEV1 between 60% and 80% of the predicted value
4. Patient willing to perform all study related procedures including the use of study inhalers, spirometer and peak flow meter.
5. Positive response to the reversibility test
6. Negative urine pregnancy test at screening visit, in women of child bearing age group and willing to use acceptable contraceptive measures during the study period or women who have been permanently sterilized or attained menopause. Male patients should use double barrier contraceptive measures
1. Inability to carry out pulmonary function testing
2. Chronic Obstructive Pulmonary Disease (COPD)
3. Pregnant or lactating women
4. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
5. History of near fatal asthma exacerbation
6. Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks
7. Active smoker
8. Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study
9. Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, endocrinal, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma
10. History of Diabetes mellitus
11. Clinically significant ECG Abnormality at baseline
12. History of alcohol or drug abuse
13. Known history of HPA axis disease or malfunctioning
14. Patients who have undergone major surgery in the previous 4 weeks
15. Participation in an investigational drug trial within 3 months of screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method