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)
Status and phase
Completed
Phase 3
Conditions
Asthma
Treatments
Drug: Ciclesonide
Details and patient eligibility
About
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.
Sex
All
Ages
12 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
111
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2025 Veeva Systems