Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)
The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Nebulizer Trial: Evaluation of the Influence of Particle Size of Aerosolized AMP on Bronchial Responsiveness in Patients With Asthma and the Effects of Treatment With Ciclesonide Versus Fluticasone.|
- PC20 AMP (Post-treatment Compared to Baseline) [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes.
- Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron
- Large particles = MMAD of approximately 9.9-10.6 micron
- Δ (FVC/SVC) at PC20 (AMP) [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]Change between baseline and post-treatment of the ratio of Forced Vital Capacity (FVC) and Slow Vital Capacity at PC20. Measured with either small or large partical size AMP.
- Safety and Tolerability [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2006|
|Study Completion Date:||September 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Ciclesonide 160 µg
inhaled Ciclesonide 160 µg, once daily in the morning
Active Comparator: 2
Fluticasone 100 µg
inhaled Fluticasone 100 µg, twice daily