Status:
COMPLETED
Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 mo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
1121 Patients enrolled
Trial Details
Trial ID
NCT00404547
Start Date
November 1 2006
End Date
December 1 2008
Last Update
February 1 2017
Active Locations (186)
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1
"Altana Pharma/Nycomed"
Abbotsford, Canada, V2T 3S4
2
"Altana Pharma/Nycomed"
Ajax, Canada, L1S 2H6
3
"Altana Pharma/Nycomed"
Alma, Canada, G8E 2K2
4
"Altana Pharma/Nycomed"
Anjou, Canada, H1J 1G4