MedPath

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

Phase 4
Completed
Conditions
Asthma
Interventions
Drug: Usual Care Inhaled Glucocorticosteroids
Registration Number
NCT00404547
Lead Sponsor
AstraZeneca
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 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1121
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
AlvescoCiclesonideAlvesco 320mcg / Alvesco 640mcg
Usual CareUsual Care Inhaled Glucocorticosteroids-
Primary Outcome Measures
NameTimeMethod
Change in Mean of Total Score of Asthma Control Questionnaire (ACQ)At the middle and end of the 12 week treatment period

The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome).

Secondary Outcome Measures
NameTimeMethod
Change in Patient Assessment of Asthma ControlAt baseline and at week 12

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".

Assessment of Patient Compliance During the Study12 weeks
Assessment of Patient Treatment Satisfaction12 weeks

Trial Locations

Locations (1)

"Altana Pharma/Nycomed"

🇨🇦

York, Canada

© Copyright 2025. All Rights Reserved by MedPath