The effect of fluticasone and formoterol in combination administered through Dry Powder Inhaler (DPI) versus budesonide and formoterol in combination (Symbicort Turbuhaler) in the maintenance treatment of asthma in adults.
- Conditions
- AsthmaRespiratory
- Registration Number
- ISRCTN60408425
- Lead Sponsor
- ibbs Pharmaceutical Ltd (Brazil)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 234
1. Male or female from 18 to 65 years old with known history of asthma according to Global Initiative for Asthma (GINA) update 2008 criteria for at least three months.
2. Patients with partially controlled or non-controlled asthma using therapeutic doses of inhaled corticosteroid combined with long-acting bronchodilator (daily doses equal or more than 400 mcg of budesonide or similar drugs) for at least four weeks
3. Forced Expiratory Volume in 1 second (FEV1) > 60 % of predicted normal value
4. Willing and able to keep diary and attend all visits
5. Written informed consent obtained
1. Pregnant or nursing womem
2. Females of childbearing potential withoud an effective method of birth control
3. Use of systemic corticosteroid within 30 days before randomization
4. Three or more treatments with oral corticosteroid or history of asthma hospitalization in the previous six months
5. Use of the following drugs within two weeks before randomization:
5.1. meltixantines
5.2. monoaminoxidases
5.3. beta-blockers
5.4. acetilscisteine
5.5. carbocisteine
5.6. triciclic antidepressive
5.7. sodium channel blockers
5.8. leukotriene
5.9. anticolinergic
5.10. phenotiazidics
5.11. immunotherapy
5.12. levodopa
5.13. ritonavir
5.14. oral ketoconozal
6. Current evidence of history of hypersensitivity to the study drug
7. Evidence of non-adhesion to the treatment during run-in phase
8. A smoking history equivalent to 10 pack years (i.e., at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc)
9. Clinically significant laboratory test results during the screening phase
10. Morning serum level of cortisol < 5 mcg/dL
11. Inability to perform the lung function test
12. Current evidence of other pulmonary disease
13. Patients with asthma exacerbation during the run-in period
14. Evidence of clinically significant oral candidiasis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the effect of the combined fluticasone and formoterol DPI BID for 12 weeks compared to the combined budesonide and formoterol Turbuhaler BID for 12 week using morning peak expiratory flow rate (PEFR)
- Secondary Outcome Measures
Name Time Method 1. FEV1<br>2. Evening peak expiratory flow rate (PEFR) <br>3. Clinical endpoints <br>3.1. frequency of asthma exacerbations & symptoms<br>3.2. rescue medication and others patient data captured in diary)