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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inhaled budesonide and formeterol plus oral montelukast | Experimental | 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 doxophylline | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhaled budesonide and formeterol plus oral montelukast | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome was percentage of improvement in FEV1 | 10 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Yogesh A Patel, M.B.B.S | Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India | Principal Investigator |
| Dr. Chandrabhanu R Tripathi, MD | Professor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Takthasinhji General Hospital Bhavnagar, Gujarat, India | Bhavnagar | Gujarat | 364001 | India |
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| inhaled budesonide and formeterol plus oral doxophylline | Drug | 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 | Drug | 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 |
|
| ID | Term |
|---|---|
| C093875 | montelukast |
| C029797 | doxofylline |
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