Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Asthma

Intervention / Treatment
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* Drug: Ciclesonide
* Drug: Fluticasone


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: History of bronchial asthma FEV1 > 1.20 L Positive Skin Prick Test Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit Main Exclusion Criteria: Clinically relevant abnormal laboratory values Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids Chronic obstructive pulmonary disease (COPD) and /or other relevant lung diseases One asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit Current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit Positive response to saline challenge at baseline visits Positive bronchial hyperresponsiveness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Ciclesonide 160 µg | Drug: Ciclesonide<br>* inhaled Ciclesonide 160 µg, once daily in the morning<br>|
| Active Comparator: 2<br>Fluticasone 100 µg | Drug: Fluticasone<br>* inhaled Fluticasone 100 µg, twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PC20 AMP (Post-treatment Compared to Baseline) | 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 | Baseline and 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Δ (FVC/SVC) at PC20 (AMP) | 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. | Baseline and 5 weeks | 
| Safety and Tolerability |  | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, AMP, Ciclesonide, Fluticasone propionate