Efficacy and safety of Salmeterol/Fluticasone DPI HEXAL versus Seretide™ Accuhaler™ 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 sites472 target enrollmentApril 9, 2009

Overview

No summary available.

Registry

who.int

Start Date

April 9, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Inclusion criteria 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 according to local requirements by one or both of the patient’s parent(s) or legal representative and by the patient, if applicable, 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 preceding Visit \-1
•5\.Regular treatment with high\-dose ICS alone or low\- to high\-dose ICS plus LABA within the 4 weeks preceding 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 Visit \-1: At least 12% and 200 ml increase of FEV1 compared to baseline after the stepwise reversibility test
•8\.Ability to read and write and to fill in the patient diary and the patient’s device preference questionnaire
•9\.Ability to handle correctly the asthma monitor

•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) and middle ear infection 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
•10\.Smoking habits: current smokers or smokers who stopped smoking less than 6 months before Visit \-1 or former smokers with a history of \= 10 pack\-years.