Controller Medications in the Management of Bronchial Asthma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Moderate to Severe Persistent Bronchial Asthma

Intervention / Treatment
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* Drug: inhaled budesonide and formeterol plus oral montelukast
* Drug: inhaled budesonide and formeterol plus oral doxophylline
* Drug: Doubling the dose of inhaled budesonide and formeterol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhaled budesonide and formeterol plus oral montelukast<br>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 | Drug: inhaled budesonide and formeterol plus oral montelukast<br>* 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 tablet montelukast (10 mg/day)orally in the evening<br>|
| Experimental: inhaled budesonide and formeterol plus oral doxophylline<br>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 | Drug: inhaled budesonide and formeterol plus oral doxophylline<br>* 1st two weeks -run in period, all 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 doxophylline sustained release(400 mg/day)orally in the morning<br>|
| Experimental: Doubling the dose of inhaled budesonide and formeterol<br>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 | Drug: Doubling the dose of inhaled budesonide and formeterol<br>* 1st two weeks -run in period, all groups 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was percentage of improvement in FEV1 |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |