Efficacy and safety of Salmeterol/Fluticasone MDI HEXAL versus SeretideTM EvohalerTM in adolescent and adult patients with moderate-to-severe persistent asthma: A 12-week, multicenter, randomized, double-blind, double-dummy, parallel-group study

HEXAL AG0 sites480 target enrollmentMay 28, 2008

Overview

No summary available.

Registry

who.int

Start Date

May 28, 2008

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•At Visit \-1:
•1\. Male or female patients aged 12 to 65 years
•2\. Written informed consent signed by the patient or for patients younger than 18 years (adolescents) signed also by the parent(s) or by the legal guardian prior to any protocol specific procedures
•3\. Medical history of moderate\-to\-severe persistent asthma (according to GINA) of at least 6 months duration
•4\. Regular use of ICS or ICS plus LABA over the 6 months immediately prior to Visit \-1
•5\. Regular treatment with high\-dose ICS alone or low\- to high\-dose ICS plus LABA within the 4 weeks immediately prior to Visit \-1 (see Appendix V for daily dosages of ICS according to GINA)
•6\. FEV1 \=50% of the predicted value by the European Community for Coal and Steel (ECCS) after a washout period of at least 6 hours for rapid\-acting beta\-2\-agonists (RABA) and at least 12 hours for LABA
•7\. Reversible and variable airflow limitation: at least 15% increase of FEV1 15\-20 min after RABA inhalation (200 µg salbutamol). Reversibility has to be demonstrated at Visit \-1 or needs to be documented by valid spirometric results, obtained with 200\-400µg of salbutamol, within 6 months prior to Visit \-1
•8\. Ability to read and write and to fill in the patient diary
•9\. Ability to handle correctly the metered\-dose inhalers and the peak flow meter

•At Visit \-1:
•1\. Intermittent or persistent mild asthma as defined by GINA
•2\. Evidence of any active concomitant pulmonary disease other than asthma, i.e. chronic bronchitis, COPD
•3\. Respiratory tract infection (including sinusitis) within 4 weeks prior to Visit \-1
•4\. Acute asthma exacerbation within 4 weeks preceding Visit \-1
•5\. Acute asthma exacerbation requiring hospitalization or emergency room visit within 12 weeks preceding Visit \-1
•6\. History of life\-threatening acute attacks or intubation for asthma
•7\. History of seasonal asthma exacerbation
•8\. History of paradoxical bronchospasm after inhaled asthma therapy
•9\. Active or inactive lung tuberculosis