Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either receive Alvesco® or usual care.

Official Title
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An Open-Label Randomized, Multicenter Study in Patients With Asthma to Evaluate the Effectiveness of Alvesco® (Ciclesonide) Compared to Asthma Usual Care in a Primary Practice Setting

Conditions
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Asthma

Intervention / Treatment
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* Drug: Ciclesonide
* Drug: Usual Care Inhaled Glucocorticosteroids


Participation Criteria
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Eligibility Criteria
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Main inclusion criteria: Written informed consent 18 years or older with diagnosis of asthma for at least 6 months Clinically stable asthma at the time of study enrollment Clinical requirements for treatment with ICS as outlined in the Canadian Asthma Consensus Guidelines If patients are currently on ICS, the dose must be stable for 3 months and they must be willing to switch Main exclusion criteria: On combination therapy (ICS + long acting beta-2-agonist) for asthma in the past 3 months or require combination therapy Severe asthma, one or more asthma exacerbations in the last 3 months requiring hospitalization or emergency room visit, or patients who have used systemic steroids more than 3 times in the past 6 months or who are currently using systemic steroids Mild asthma requiring short acting beta-2-agonists only Patients with a contraindication to ICS therapy Any other disease or medical condition requiring further clinical evaluation, which in the opinion of the Primary Care Practitioner may interfere with the clinical study or interfere with the diagnosis of asthma. Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alvesco<br>Alvesco 320mcg / Alvesco 640mcg | Drug: Ciclesonide<br>* Asthma Care with Alvesco<br>|
| Active Comparator: Usual Care<br> | Drug: Usual Care Inhaled Glucocorticosteroids<br>* Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean of Total Score of Asthma Control Questionnaire (ACQ) | The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome). | At the middle and end of the 12 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Assessment of Asthma Control | Patient assessment of asthma control was assessed at baseline and at week 12 using the question How would you rate the control of your asthma symptoms?. The change in this assessment was categorized in Improvement and Non-Improvement. | At baseline and at week 12 | 
| Assessment of Patient Compliance During the Study |  | 12 weeks | 
| Assessment of Patient Treatment Satisfaction |  | 12 weeks | 

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