Ciclesonide for the Treatment of Airway Hyperresponsiveness

Study Overview
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Brief Summary
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The study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. The study duration consists of a treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.

Official Title
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Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-blind, Randomized, Parallel Group Study.

Conditions
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Asthma

Intervention / Treatment
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* Drug: Ciclesonide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness. Asthma symptoms partly controlled according to GINA (October 2006) 1 week prior to randomization FEV1 ≥ 70% predicted 18 - 70 years old Exclusion Criteria: Smoker and ex-smoker with >10 pack years COPD Upper respiratory tract infection within the past 4 weeks. ICS or oral steroids during the previous month before inclusion b-blockers within the past 4 weeks Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers) Pregnancy Known malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Ciclesonide 320µg | Drug: Ciclesonide<br>* 320µg Ciclesonide versus Placebo<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given) |  | 4 weeks | 
| Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment |  | 4 weeks | 
| Level of exhaled nitric oxide after 4 weeks of treatment |  | 4 weeks | 
| mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper) |  | 4 weeks | 
| Mean change of ACQ after 4 weeks of treatment |  | 4 weeks | 
| Mean change of AQLQ after 4 weeks of treatment |  | 4 weeks | 
| Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment |  | 4 weeks | 
| Exacerbation rates during the 4 weeks of treatment |  | 4 weeks | 

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