A clinical trial to study the effects of Salmeterol/Fluticasone in patients with Persistent Asthma.
- Conditions
- Health Condition 1: null- Persistent Asthma
- Registration Number
- CTRI/2011/11/002161
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 372
1. The patient provides written informed consent to participate in the study
2. Male or female patient aged >=12 years
3. Documented diagnosis of asthma
4. FEV1 between 50% and 80% of the predicted value
5. Patient willing to perform all study related procedures including the use of study inhalers, spirometer and peak flow meter.
6. Female participants must have a negative pregnancy test at screening visit and willing to use acceptable contraceptive measures during the study. Males must agree to use barrier contraception while on study medication and for 90 days after taking the last dose of study medication.
1. Patient with Chronic Obstructive Pulmonary Disease (COPD)
2. Pregnant or lactating women
3. Patients with a history of hypersensitivity to Salmeterol/Fluticasone and/or any other ingredients
4. History of Asthma exacerbation and hospitalization needed due to asthma within the last 3 months prior to the study
5. Patients diagnosed with Intermittent, seasonal or exercise Induced Asthma
6. Patients with active smoking
7. 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
8. 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 patientâ??s participation in the study or that may prevent the successful completion of the study
9. Clinically significant ECG Abnormality at baseline
10. Patients with documented or suspected or current history of alcohol and drug abuse
11. Patients who have undergone major surgery in the previous 4 weeks
12. 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 The mean difference between groups in Forced Expiratory Volume in 1 second (FEV1) value at the End of Treatment VisitTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Change in asthma symptom scoreTimepoint: 12 weeks;Change in nocturnal asthma symptom scoreTimepoint: 12 weeks;Change over the weeks in evening PEFTimepoint: 12 weeks;Change over the weeks in morning PEFTimepoint: 12 weeks;Investigator global impressionTimepoint: 12 weeks;Patient global impressionTimepoint: 12 weeks