Skip to main content
OpenTrials
Completed

NCT Number: NCT00404547

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

"Altana Pharma/Nycomed", Abbotsford British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciclesonide

Drug

Asthma Care with Alvesco

Usual Care Inhaled Glucocorticosteroids

Drug

Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 28, 2006
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.