A Randomized, Open Labeled Comparative Study to Assess the Efficacy and Safety of Controller Medications as Add on to Inhaled Steroid and Long Acting β2 Agonist in Treatment of Moderate to Severe Persistent Bronchial Asthma
Overview
- Phase
- Not Applicable
- Intervention
- inhaled budesonide and formeterol plus oral montelukast
- Conditions
- Moderate to Severe Persistent Bronchial Asthma
- Sponsor
- Government Medical College, Bhavnagar
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The primary outcome was percentage of improvement in FEV1
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of this study is to know the effect of another controller medication add on to the inhaled corticosteroid and long acting β2 agonist on clinical symptom, lung function and compliance in patients of moderate to severe persistent bronchial asthma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •aged between 15 to 65 years of either sex
- •had clinically diagnosed Bronchial asthma
- •had poor asthma control defined by ACQ score (asthma control questionnaire) of 1.5 or greater
- •FEV1 (Forced Expiratory Volume at 1 second) value of 50% or more of predicted
- •improvement in FEV1 was greater than 15% after bronchodilator inhalation
Exclusion Criteria
- •major illness of system other than respiratory major respiratory illness other than asthma taken long acting anti histaminic within a preceding week of enrollment Smokers Pregnant and lactating woman history of hypersensitivity to any of above drugs
Arms & Interventions
inhaled budesonide and formeterol plus oral montelukast
1st two weeks -run in period .All three participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet montelukast (10 mg/day)orally in the evening
Intervention: inhaled budesonide and formeterol plus oral montelukast
inhaled budesonide and formeterol plus oral doxophylline
1st two weeks -run in period, all three participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks
Intervention: inhaled budesonide and formeterol plus oral doxophylline
Doubling the dose of inhaled budesonide and formeterol
1st two weeks -run in period all the participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg /puff + formeterol 6 mcg/puff) two times a day plus metered dose inhaler of budesonide (200 mcg/puff) two times a day
Intervention: Doubling the dose of inhaled budesonide and formeterol
Outcomes
Primary Outcomes
The primary outcome was percentage of improvement in FEV1
Time Frame: 10 weeks
Secondary Outcomes
- Improvement in PEFR (Peak expiratory flow rate), ACQ scores(asthma control questionnaire score), rates of adverse drug reaction and EPACs (episodes of poor asthma control)(10 weeks)