A clinical trial to study the effects of Fixed Dose Combinations of Fluticasone Plus Formoterol in patients with Asthma.
- Conditions
- Health Condition 1: null- Asthma
- Registration Number
- CTRI/2012/02/002405
- 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 and/or legally accepted representative (LAR) provides written informed consent to participate in the study.
2. Male or female patient aged between 16 to 70 years with known history of moderate-severe persistent, reversible asthma for >= 6 months.
3. FEV1 between >=40% to < 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. Females of child bearing age must have a negative pregnancy test at screening visit, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study.
1. Inability to carry out pulmonary function testing
2. Significant, non-reversible, active pulmonary disease
3. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
4. History of near fatal asthma within the past one year
5. Evidence of severe asthma exacerbation or upper or lower respiratory tract infections within the past 4 weeks
6. Active smoker
7. Subjects who are using any medication or have 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. History of uncontrolled Diabetes mellitus
10. Clinically significant ECG Abnormality at baseline
11. Use of prohibited medication
12. Patients who received any investigational new drug within the last 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean difference between groups in FEV1 value at the End of Treatment VisitTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Average need for use of short acting β 2 agonistsTimepoint: 12 weeks;Change in asthma symptom scoreTimepoint: 12 weeks;Change in Diurnal variability of PEFTimepoint: 12 weeks;Change in evening PEFTimepoint: 12 weeks;Change in morning PEFTimepoint: 12 weeks;Change in nocturnal asthma symptomTimepoint: 12 weeks;Number of asthma exacerbationsTimepoint: 12 weeks