Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)

Study Overview
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Brief Summary
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The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary function and time to first exacerbation in patients with moderate persistent asthma. Ciclesonide will be administered once daily in the evening at two dose levels. The study duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).

Official Title
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A Pilot Study on the Impact of Two Different Doses of Ciclesonide (160 mcg/Day and 320 mcg/Day) Administered in the Evening on Quality of Life in Patients With Moderate Persistent Asthma.

Conditions
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Asthma

Intervention / Treatment
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* Drug: Ciclesonide


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Written informed consent Good health with the exception of asthma Clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit B0 Pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg BDP / day at stable dosing during the last 4 weeks prior to visit B0, concomitant or not to short-acting beta2-agonists treatment as rescue medication FEV1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit B0 Reversibility ≥ 12% and ≥ 200 mL in B0, B0 or T0, after inhalation of 400 mcg of salbutamol Patients compliant to recommended pre-treatment Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids Chronic obstructive pulmonary disease (COPD) Hospitalization within previous four weeks from baseline Hospitalization due to asthma within the last twelve months Asthma exacerbation within two months previous to baseline History of almost fatal asthma at any moment Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women Exacerbation of asthma within 2 months prior to entry into the baseline period Use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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 160µg | Drug: Ciclesonide<br>* Effect of Ciclesonide on Quality of Life<br>|
| Active Comparator: 2<br>Ciclesonide 320µg | Drug: Ciclesonide<br>* Effect of Ciclesonide on Quality of Life<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in Quality of Life from AQLQ(S) (T end versus T0) |  | 8 weeks | 
| time to first exacerbation |  | 8 weeks | 
| differences in FEV1 and FVC from spirometry (T end vs T0). |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of days on which patients perceived asthma control |  | 8 weeks | 
| percentage of asthma symptoms free days |  | 8 weeks | 
| percentage of rescue medication-free days |  | 8 weeks | 
| percentage of nocturnal awakening-free days |  | 8 weeks | 
| asthma symptom score (daytime score, nighttime score, total score) |  | 8 weeks | 
| use of rescue medication |  | 8 weeks | 
| PEF from spirometry |  | 8 weeks | 
| morning and evening PEF from diary |  | 8 weeks | 
| diurnal PEF fluctuation. |  | 8 weeks | 

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