Controller Medications in the Management of Bronchial Asthma
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 25, 2010
CompletedJanuary 25, 2010
January 1, 2010
6 months
January 22, 2010
January 22, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome was percentage of improvement in FEV1
10 weeks
Secondary Outcomes (1)
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
Study Arms (3)
inhaled budesonide and formeterol plus oral montelukast
EXPERIMENTAL1st 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 doxophylline
EXPERIMENTAL1st 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
EXPERIMENTAL1st 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
Interventions
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
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
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sir Takthasinhji General Hospital Bhavnagar, Gujarat, India
Bhavnagar, Gujarat, 364001, India
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Yogesh A Patel, M.B.B.S
Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India
- STUDY CHAIR
Dr. Chandrabhanu R Tripathi, MD
Professor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 25, 2010
Study Start
December 1, 2008
Primary Completion
June 1, 2009
Study Completion
July 1, 2009
Last Updated
January 25, 2010
Record last verified: 2010-01