ISRCTN60408425
Completed
Not Applicable
Prospective, open, multicentre study on the effect of fluticasone and formoterol in combination administered through Dry Powder Inhaler (DPI) compared to budesonide and formoterol in combination (Symbicort Turbuhaler) in the maintenance treatment of asthma in adults.
ibbs Pharmaceutical Ltd (Brazil)0 sites234 target enrollmentJanuary 20, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- ibbs Pharmaceutical Ltd (Brazil)
- Enrollment
- 234
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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