Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Ciclesonide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: ALTANA Pharma Official(s) and/or principal investigator(s):
Paul O’Byrne, Prof., Study Chair, Affiliation: McMaster University in Hamilton, Ontario, Canada
Søren Pedersen, Prof., Study Chair, Affiliation: University of Odense, Kolding, Denmark
D.S. Postma, Prof., Study Chair, Affiliation: University Hospital of Groningen, The Netherlands
Summary
The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of
fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients
with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a
treatment period (12 months). The study will provide further data on safety and tolerability
of ciclesonide.
Clinical Details
Official title: Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-Term Asthma Control
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: time until the first severe asthma exacerbation occursnumber of poorly controlled asthma days.
Secondary outcome: percentage of days with asthma controlpercentage of days with asthma symptoms percentage of nocturnal awakenings due to asthma asthma symptom score number of inhalations of rescue medication proportion of patients with severe asthma exacerbations differences in morning PEF from diary differences in FEV1 and FVC from spirometry blood eosinophils AQLQ(S) health economic data vital signs laboratory work-up adverse events.
Eligibility
Minimum age: 12 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Main Inclusion Criteria:
- Clinical diagnosis of mild persistent asthma
- Pre-treatment with SABAs only
- FEV1 ≥80% predicted
- Good health with the exception of asthma
Main Exclusion Criteria:
- Concomitant severe diseases or diseases which are contraindications for the use of
inhaled steroids
- COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing
alternating impairment in pulmonary function
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
- Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
Locations and Contacts
ALTANA Pharma, Cities in Australia, Australia
ALTANA Pharma, Cities in Canada, Canada
ALTANA Pharma, Cities in the Czech Republic, Czech Republic
ALTANA Pharma, Cities in Hungary, Hungary
ALTANA Pharma, Cities in Poland, Poland
ALTANA Pharma, Cities in South Africa, South Africa
ALTANA Pharma, Cities in Spain, Spain
Additional Information
Starting date: September 2003
Last updated: December 15, 2006
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