To know whether the newer drug combination i.e. Vilanterol-Fluticasone is better than the conventionally use combination Formoterol-Budesonide in terms of effectiveness in controlling asthma symptoms and improving lung function in stable asthma patients or not.
Not Applicable
- Conditions
- Health Condition 1: J453- Mild persistent asthmaHealth Condition 2: J454- Moderate persistent asthma
- Registration Number
- CTRI/2023/05/052174
- Lead Sponsor
- Department of Pulmonary, Critical Care and sleep Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Stable asthma patients on formoterol-budesonide combination with following eligibility criteria:
1. >18 years of age
2. On Formoterol- budesonide therapy for atleast >12 weeks prior to enrollment
Exclusion Criteria
¬Uncontrolled asthma patient (ACT score <15)
¬Severe refractory asthma
¬Patients with history of acute exacerbation of Asthma in the preceding 6 weeks
¬Patient with known or suspected allergy to VI-FF
¬Asthma patients with other respiratory co-morbidities like COPD, lung cancer and interstitial lung disease.
Patients who are not able to perform spirometry
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the change in FEV1 after 8 weeks of vilanterol-fluticasone furoate versus formoterol-budesonide combination therapy. <br/ ><br>Timepoint: All patients will be evaluated at Day 0 ( day of enrolment) and at 4th and 8th week to assess improvement in asthma symptoms.
- Secondary Outcome Measures
Name Time Method To compare the change in ACT (Asthma control test) after 8 weeks of vilanterol-fluticasone furoate versus formoterol-budesonide combination therapy. <br/ ><br>Timepoint: All patients will be evaluated at Day 0 ( day of enrolment) and at 4th and 8th week.