Controller Medications in the Management of Bronchial Asthma
NCT ID: NCT01055041
Last Updated: 2010-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2008-12-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
inhaled budesonide and formeterol plus oral montelukast
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
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
inhaled budesonide and formeterol plus oral doxophylline
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
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
Doubling the dose of inhaled budesonide and formeterol
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
Interventions
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inhaled budesonide and formeterol plus oral montelukast
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
inhaled budesonide and formeterol plus oral doxophylline
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
Doubling the dose of inhaled budesonide and formeterol
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
Eligibility Criteria
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Inclusion Criteria
* 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
15 Years
65 Years
ALL
No
Sponsors
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Government Medical College, Bhavnagar
OTHER
Responsible Party
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Government Medical College, Bhavnagar-364001, Gujarat, India
Principal Investigators
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Dr. Yogesh A Patel, M.B.B.S
Role: PRINCIPAL_INVESTIGATOR
Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India
Dr. Chandrabhanu R Tripathi, MD
Role: STUDY_CHAIR
Professor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
Locations
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Sir Takthasinhji General Hospital Bhavnagar, Gujarat, India
Bhavnagar, Gujarat, India
Countries
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Other Identifiers
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Pharmacol no.03 /2008 Research
Identifier Type: -
Identifier Source: org_study_id
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