Controller Medications in the Management of Bronchial Asthma

Not Applicable

Completed

• Conditions: Moderate to Severe Persistent Bronchial Asthma
• Interventions: Drug: inhaled budesonide and formeterol plus oral doxophylline; Drug: Doubling the dose of inhaled budesonide and formeterol; Drug: inhaled budesonide and formeterol plus oral montelukast

• Registration Number: NCT01055041
• Lead Sponsor: Government Medical College, Bhavnagar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Status Verified: 2010-01
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Last Update Submitted: 2010-01-22
• Study First Posted: 2010-01-25
• Last Update Posted: 2010-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inhaled budesonide and formeterol plus oral doxophylline	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
Doubling the dose of inhaled budesonide and formeterol	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
inhaled budesonide and formeterol plus oral montelukast	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

Primary Outcome Measures

Name	Time	Method
The primary outcome was percentage of improvement in FEV1	10 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sir Takthasinhji General Hospital Bhavnagar, Gujarat, India; 🇮🇳 Bhavnagar, Gujarat, India