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 个研究点目标入组 234 人开始时间: 2010年1月20日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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

发起方

ibbs Pharmaceutical Ltd (Brazil)