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

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Ciclesonide Drug: Usual Care Inhaled Glucocorticosteroids	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Ciclesonide

U.S. FDA Resources

Further study details as provided by Takeda:

Primary Outcome Measures:

Change in Mean of Total Score of Asthma Control Questionnaire (ACQ) [ Time Frame: At the middle and end of the 12 week treatment period ] [ Designated as safety issue: No ]
The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome).

Secondary Outcome Measures:

Change in Patient Assessment of Asthma Control [ Time Frame: At baseline and at week 12 ] [ Designated as safety issue: No ]
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 Study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Assessment of Patient Treatment Satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	1121
Study Start Date:	November 2006
Study Completion Date:	December 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Alvesco Alvesco 320mcg / Alvesco 640mcg	Drug: Ciclesonide Asthma Care with Alvesco
Active Comparator: Usual Care	Drug: Usual Care Inhaled Glucocorticosteroids Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404547

Show 186 Study Locations

Sponsors and Collaborators

Takeda

Investigators

Principal Investigator:

Charles KN Chan, MD

Joint Division of Respirology University Health Network & Mt. Sinai Hospital Medical Director, Endoscopy Services & Thoracic Business Unit

More Information

No publications provided

Responsible Party:	Nycomed GmbH (Ex ALTANA Pharma)
ClinicalTrials.gov Identifier:	NCT00404547 History of Changes
Other Study ID Numbers:	BY9010/CA-102
Study First Received:	November 27, 2006
Results First Received:	March 8, 2010
Last Updated:	May 4, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Takeda:

Asthma
Alvesco®
Ciclesonide

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Ciclesonide
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013