Phase 4
Completed N=1,121
Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)
Source: ClinicalTrials.gov NCT00404547 ↗Enrolled (actual)
1,121
Serious AEs
0.6%
Results posted
Mar 2010
Primary outcomePrimary: Change in Mean of Total Score of Asthma Control Questionnaire (ACQ) — -0.76; -0.37 points on a scale — p=<0.0001
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean of Total Score of Asthma Control Questionnaire (ACQ) |
-0.76; -0.37 | <0.0001 sig |
| SECONDARY Change in Patient Assessment of Asthma Control |
422; 132; 284; 209; 6; 4 | — |
| SECONDARY Assessment of Patient Compliance During the Study |
— | — |
| SECONDARY Assessment of Patient Treatment Satisfaction |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00404547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.