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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014