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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00404547
First received: November 27, 2006
Last updated: May 4, 2012
Last verified: March 2010

November 27, 2006
May 4, 2012
November 2006
April 2008   (final data collection date for primary outcome measure)
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).
Change in mean score of total score of Asthma Control Questionnaire (ACQ)
Complete list of historical versions of study NCT00404547 on ClinicalTrials.gov Archive Site
  • 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 ]
Change in mean score of patient assessment of asthma control, Comparison between change in patient assessment of asthma control and change in ACQ, Assessment of patient compliance during the study, Assessment of patient treatment satisfaction
Not Provided
Not Provided
 
Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Drug: Ciclesonide
    Asthma Care with Alvesco
  • Drug: Usual Care Inhaled Glucocorticosteroids
    Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment
  • Active Comparator: Alvesco
    Alvesco 320mcg / Alvesco 640mcg
    Intervention: Drug: Ciclesonide
  • Active Comparator: Usual Care
    Intervention: Drug: Usual Care Inhaled Glucocorticosteroids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1121
December 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00404547
BY9010/CA-102
No
Nycomed GmbH (Ex ALTANA Pharma)
Takeda
Not Provided
Principal Investigator: Charles KN Chan, MD Joint Division of Respirology University Health Network & Mt. Sinai Hospital Medical Director, Endoscopy Services & Thoracic Business Unit
Takeda
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP