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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01055041 |
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Date of registration:
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22/01/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Controller Medications in the Management of Bronchial Asthma
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Scientific 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 ß2 Agonist in Treatment of Moderate to Severe Persistent Bronchial Asthma |
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Date of first enrolment:
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December 2008 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01055041 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr. Yogesh A Patel, M.B.B.S |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India |
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Name:
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Dr. Chandrabhanu R Tripathi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India |
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Key inclusion & exclusion 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
Age minimum:
15 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Moderate to Severe Persistent Bronchial Asthma
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Intervention(s)
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Drug: inhaled budesonide and formeterol plus oral montelukast
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Drug: inhaled budesonide and formeterol plus oral doxophylline
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Drug: Doubling the dose of inhaled budesonide and formeterol
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Primary Outcome(s)
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The primary outcome was percentage of improvement in FEV1
[Time Frame: 10 weeks]
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Secondary Outcome(s)
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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)
[Time Frame: 10 weeks]
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Secondary ID(s)
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Pharmacol no.03 /2008 Research
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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