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

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ClinicalTrials.gov Identifier: NCT00404547
Recruitment Status : Completed
First Posted : November 28, 2006
Results First Posted : March 26, 2010
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Drug: Usual Care Inhaled Glucocorticosteroids Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2006
Primary Completion Date : April 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Ciclesonide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change in Mean of Total Score of Asthma Control Questionnaire (ACQ) [ Time Frame: 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 :
  1. Change in Patient Assessment of Asthma Control [ Time Frame: At 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".

  2. Assessment of Patient Compliance During the Study [ Time Frame: 12 weeks ]
  3. Assessment of Patient Treatment Satisfaction [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404547


  Show 186 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00404547     History of Changes
Other Study ID Numbers: BY9010/CA-102
First Posted: November 28, 2006    Key Record Dates
Results First Posted: March 26, 2010
Last Update Posted: February 1, 2017
Last Verified: September 2016

Keywords provided by AstraZeneca:
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
Anti-Allergic Agents