Clinical trial NCT00404547: Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Alvesco®
Ciclesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-11-28
Enrollment: 1121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Mean of Total Score of Asthma Control Questionnaire (ACQ)
timeFrame: At the middle and end of the 12 week treatment period
Secondary outcomes:
measure: Change in Patient Assessment of Asthma Control
timeFrame: At baseline and at week 12
measure: Assessment of Patient Compliance During the Study
timeFrame: 12 weeks
measure: Assessment of Patient Treatment Satisfaction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: "Altana Pharma/Nycomed"
city: Ajax
country: Canada
facility: "Altana Pharma/Nycomed"
city: Alma
country: Canada
facility: "Altana Pharma/Nycomed"
city: Anjou
country: Canada
facility: "Altana Pharma/Nycomed"
city: Anjou
country: Canada
facility: "Altana Pharma/Nycomed"
city: Barrie
country: Canada
facility: "Altana Pharma/Nycomed"
city: Brampton
country: Canada
facility: "Altana Pharma/Nycomed"
city: Brampton
country: Canada
facility: "Altana Pharma/Nycomed"
city: Brampton
country: Canada
facility: "Altana Pharma/Nycomed"
city: Brampton
country: Canada
facility: "Altana Pharma/Nycomed"
city: Brampton
country: Canada
facility: "Altana Pharma/Nycomed"
city: Brossard
country: Canada
facility: "Altana Pharma/Nycomed"
city: Burnaby
country: Canada
facility: "Altana Pharma/Nycomed"
city: Burnaby
country: Canada
facility: "Altana Pharma/Nycomed"
city: Cacouna
country: Canada
facility: "Altana Pharma/Nycomed"
city: Calgary
country: Canada
facility: "Altana Pharma/Nycomed"
city: Calgary
country: Canada
facility: "Altana Pharma/Nycomed"
city: Calgary
country: Canada
facility: "Altana Pharma/Nycomed"
city: Calgary
country: Canada
facility: "Altana Pharma/Nycomed"
city: Calgary
country: Canada
facility: "Altana Pharma/Nycomed"
city: Calgary
country: Canada
facility: "Altana Pharma/Nycomed"
city: Calgary
country: Canada
facility: "Altana Pharma/Nycomed"
city: Calgary
country: Canada
facility: "Altana Pharma/Nycomed"
city: Cambridge
country: Canada
facility: "Altana Pharma/Nycomed"
city: Collingwood
country: Canada
facility: "Altana Pharma/Nycomed"
city: Conception Bay S
country: Canada
facility: "Altana Pharma/Nycomed"
city: Cornwall
country: Canada
facility: "Altana Pharma/Nycomed"
city: Corunna
country: Canada
facility: "Altana Pharma/Nycomed"
city: Courcelette
country: Canada
facility: "Altana Pharma/Nycomed"
city: Delta
country: Canada
facility: "Altana Pharma/Nycomed"
city: Delta
country: Canada
facility: "Altana Pharma/Nycomed"
city: Dolbeau-Mistassini
country: Canada
facility: "Altana Pharma/Nycomed"
city: Edmonton
country: Canada
facility: "Altana Pharma/Nycomed"
city: Etobicoke
country: Canada
facility: "Altana Pharma/Nycomed"
city: Fort Erie
country: Canada
facility: "Altana Pharma/Nycomed"
city: Gatineau (Sector Hull)
country: Canada
facility: "Altana Pharma/Nycomed"
city: Gatineau
country: Canada
facility: "Altana Pharma/Nycomed"
city: Gatineau
country: Canada
facility: "Altana Pharma/Nycomed"
city: Gatineau
country: Canada
facility: "Altana Pharma/Nycomed"
city: Gatineau
country: Canada
facility: "Altana Pharma/Nycomed"
city: Gatineau
country: Canada
facility: "Altana Pharma/Nycomed"
city: Gatineau
country: Canada
facility: "Altana Pharma/Nycomed"
city: Grand Falls
country: Canada
facility: "Altana Pharma/Nycomed"
city: Halifax
country: Canada
facility: "Altana Pharma/Nycomed"
city: Harrow
country: Canada
facility: "Altana Pharma/Nycomed"
city: Hastings
country: Canada
facility: "Altana Pharma/Nycomed"
city: Hull
country: Canada
facility: "Altana Pharma/Nycomed"
city: Hull
country: Canada
facility: "Altana Pharma/Nycomed"
city: Joliette
country: Canada
facility: "Altana Pharma/Nycomed"
city: Joliette
country: Canada
facility: "Altana Pharma/Nycomed"
city: Jonquiere
country: Canada
facility: "Altana Pharma/Nycomed"
city: Kamloops
country: Canada
facility: "Altana Pharma/Nycomed"
city: Kentville
country: Canada
facility: "Altana Pharma/Nycomed"
city: Keswick
country: Canada
facility: "Altana Pharma/Nycomed"
city: Kingston
country: Canada
facility: "Altana Pharma/Nycomed"
city: Kirkland
country: Canada
facility: "Altana Pharma/Nycomed"
city: Lasalle
country: Canada
facility: "Altana Pharma/Nycomed"
city: Lasalle
country: Canada
facility: "Altana Pharma/Nycomed"
city: Laval
country: Canada
facility: "Altana Pharma/Nycomed"
city: London
country: Canada
facility: "Altana Pharma/Nycomed"
city: London
country: Canada
facility: "Altana Pharma/Nycomed"
city: London
country: Canada
facility: "Altana Pharma/Nycomed"
city: Milton
country: Canada
facility: "Altana Pharma/Nycomed"
city: Mississauga
country: Canada
facility: "Altana Pharma/Nycomed"
city: Mississauga
country: Canada
facility: "Altana Pharma/Nycomed"
city: Mississauga
country: Canada
facility: "Altana Pharma/Nycomed"
city: Mississauga
country: Canada
facility: "Altana Pharma/Nycomed"
city: Mississauga
country: Canada
facility: "Altana Pharma/Nycomed"
city: Mississauga
country: Canada
facility: "Altana Pharma/Nycomed"
city: Moncton
country: Canada
facility: "Altana Pharma/Nycomed"
city: Montreal
country: Canada
facility: "Altana Pharma/Nycomed"
city: Montreal
country: Canada
facility: "Altana Pharma/Nycomed"
city: Montreal
country: Canada
facility: "Altana Pharma/Nycomed"
city: Montreal
country: Canada
facility: "Altana Pharma/Nycomed"
city: Montreal
country: Canada
facility: "Altana Pharma/Nycomed"
city: Montreal
country: Canada
facility: "Altana Pharma/Nycomed"
city: Montreal
country: Canada
facility: "Altana Pharma/Nycomed"
city: Montreal
country: Canada
facility: "Altana Pharma/Nycomed"
city: Mount Pearl
country: Canada
facility: "Altana Pharma/Nycomed"
city: Mount Pearl
country: Canada
facility: "Altana Pharma/Nycomed"
city: Niagara Falls
country: Canada
facility: "Altana Pharma/Nycomed"
city: North Bay
country: Canada
facility: "Altana Pharma/Nycomed"
city: North Sydney
country: Canada
facility: "Altana Pharma/Nycomed"
city: North Vancouver
country: Canada
facility: "Altana Pharma/Nycomed"
city: North Vancouver
country: Canada
facility: "Altana Pharma/Nycomed"
city: North Vancouver
country: Canada
facility: "Altana Pharma/Nycomed"
city: North York
country: Canada
facility: "Altana Pharma/Nycomed"
city: Oakville
country: Canada
facility: "Altana Pharma/Nycomed"
city: Oshawa
country: Canada
facility: "Altana Pharma/Nycomed"
city: Oshawa
country: Canada
facility: "Altana Pharma/Nycomed"
city: Ottawa
country: Canada
facility: "Altana Pharma/Nycomed"
city: Ottawa
country: Canada
facility: "Altana Pharma/Nycomed"
city: Ottawa
country: Canada
facility: "Altana Pharma/Nycomed"
city: Penticton
country: Canada
facility: "Altana Pharma/Nycomed"
city: Penticton
country: Canada
facility: "Altana Pharma/Nycomed"
city: Perth Andover
country: Canada
facility: "Altana Pharma/Nycomed"
city: Point Edward
country: Canada
facility: "Altana Pharma/Nycomed"
city: Pointe-Claire
country: Canada
facility: "Altana Pharma/Nycomed"
city: Princeville
country: Canada
facility: "Altana Pharma/Nycomed"
city: Quebec
country: Canada
facility: "Altana Pharma/Nycomed"
city: Quebec
country: Canada
facility: "Altana Pharma/Nycomed"
city: Quebec
country: Canada
facility: "Altana Pharma/Nycomed"
city: Red Deer
country: Canada
facility: "Altana Pharma/Nycomed"
city: Regina
country: Canada
facility: "Altana Pharma/Nycomed"
city: Regina
country: Canada
facility: "Altana Pharma/Nycomed"
city: Repentigny
country: Canada
facility: "Altana Pharma/Nycomed"
city: Richmond Hill
country: Canada
facility: "Altana Pharma/Nycomed"
city: Richmond
country: Canada
facility: "Altana Pharma/Nycomed"
city: Rimouski
country: Canada
facility: "Altana Pharma/Nycomed"
city: Roxton Pond
country: Canada
facility: "Altana Pharma/Nycomed"
city: Saint John
country: Canada
facility: "Altana Pharma/Nycomed"
city: Sainte-Catherine
country: Canada
facility: "Altana Pharma/Nycomed"
city: Sarnia
country: Canada
facility: "Altana Pharma/Nycomed"
city: Saskatoon
country: Canada
facility: "Altana Pharma/Nycomed"
city: Saskatoon
country: Canada
facility: "Altana Pharma/Nycomed"
city: Scarborough
country: Canada
facility: "Altana Pharma/Nycomed"
city: Scarborough
country: Canada
facility: "Altana Pharma/Nycomed"
city: Sherbrooke
country: Canada
facility: "Altana Pharma/Nycomed"
city: Shubenacadie
country: Canada
facility: "Altana Pharma/Nycomed"
city: St Bruno
country: Canada
facility: "Altana Pharma/Nycomed"
city: St-Jean-sur-Richel
country: Canada
facility: "Altana Pharma/Nycomed"
city: St-Jerome
country: Canada
facility: "Altana Pharma/Nycomed"
city: St-Pie
country: Canada
facility: "Altana Pharma/Nycomed"
city: St. Catharines
country: Canada
facility: "Altana Pharma/Nycomed"
city: St. John's
country: Canada
facility: "Altana Pharma/Nycomed"
city: St. John's
country: Canada
facility: "Altana Pharma/Nycomed"
city: St. John's
country: Canada
facility: "Altana Pharma/Nycomed"
city: St. John's
country: Canada
facility: "Altana Pharma/Nycomed"
city: St. Leonard
country: Canada
facility: "Altana Pharma/Nycomed"
city: St. Romuald
country: Canada
facility: "Altana Pharma/Nycomed"
city: Ste Anne De Bellev
country: Canada
facility: "Altana Pharma/Nycomed"
city: Stirling
country: Canada
facility: "Altana Pharma/Nycomed"
city: Stouffville
country: Canada
facility: "Altana Pharma/Nycomed"
city: Sudbury
country: Canada
facility: "Altana Pharma/Nycomed"
city: Sudbury
country: Canada
facility: "Altana Pharma/Nycomed"
city: Surrey
country: Canada
facility: "Altana Pharma/Nycomed"
city: Surrey
country: Canada
facility: "Altana Pharma/Nycomed"
city: Surrey
country: Canada
facility: "Altana Pharma/Nycomed"
city: Surrey
country: Canada
facility: "Altana Pharma/Nycomed"
city: Surrey
country: Canada
facility: "Altana Pharma/Nycomed"
city: Sydney Mines
country: Canada
facility: "Altana Pharma/Nycomed"
city: Thetford Mines
country: Canada
facility: "Altana Pharma/Nycomed"
city: Thornhill
country: Canada
facility: "Altana Pharma/Nycomed"
city: Thunder Bay
country: Canada
facility: "Altana Pharma/Nycomed"
city: Thunder Bay
country: Canada
facility: "Altana Pharma/Nycomed"
city: Toronto
country: Canada
facility: "Altana Pharma/Nycomed"
city: Toronto
country: Canada
facility: "Altana Pharma/Nycomed"
city: Toronto
country: Canada
facility: "Altana Pharma/Nycomed"
city: Toronto
country: Canada
facility: "Altana Pharma/Nycomed"
city: Toronto
country: Canada
facility: "Altana Pharma/Nycomed"
city: Toronto
country: Canada
facility: "Altana Pharma/Nycomed"
city: Toronto
country: Canada
facility: "Altana Pharma/Nycomed"
city: Toronto
country: Canada
facility: "Altana Pharma/Nycomed"
city: Toronto
country: Canada
facility: "Altana Pharma/Nycomed"
city: Vancouver
country: Canada
facility: "Altana Pharma/Nycomed"
city: Vancouver
country: Canada
facility: "Altana Pharma/Nycomed"
city: Vancouver
country: Canada
facility: "Altana Pharma/Nycomed"
city: Vancouver
country: Canada
facility: "Altana Pharma/Nycomed"
city: Vancouver
country: Canada
facility: "Altana Pharma/Nycomed"
city: Verdun
country: Canada
facility: "Altana Pharma/Nycomed"
city: Verdun
country: Canada
facility: "Altana Pharma/Nycomed"
city: Victoria
country: Canada
facility: "Altana Pharma/Nycomed"
city: West Vancouver
country: Canada
facility: "Altana Pharma/Nycomed"
city: Westmount
country: Canada
facility: "Altana Pharma/Nycomed"
city: Whitby
country: Canada
facility: "Altana Pharma/Nycomed"
city: Windsor
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Winnipeg
country: Canada
facility: "Altana Pharma/Nycomed"
city: Woodstock
country: Canada
facility: "Altana Pharma/Nycomed"
city: Woodstock
country: Canada
facility: "Altana Pharma/Nycomed"
city: York
country: Canada
facility: "Altana Pharma/Nycomed"
city: York
country: Canada
facility: "Altana Pharma/Nycomed"
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: