Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)
Status and phase
Completed
Phase 4
Conditions
Asthma
Treatments
Drug: Ciclesonide
Drug: Usual Care Inhaled Glucocorticosteroids
Details and patient eligibility
About
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.
Enrollment
1,121 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
1,121 participants in 2 patient groups
Alvesco
Active Comparator group
Description:
Alvesco 320mcg / Alvesco 640mcg
Treatment:
Drug: Ciclesonide
Usual Care
Active Comparator group
Treatment:
Drug: Usual Care Inhaled Glucocorticosteroids
Trial contacts and locations
186
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Data sourced from clinicaltrials.gov
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