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

NCT ID: NCT00404547

Last Updated: 2017-02-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alvesco

Alvesco 320mcg / Alvesco 640mcg

Group Type ACTIVE_COMPARATOR

Ciclesonide

Intervention Type DRUG

Asthma Care with Alvesco

Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care Inhaled Glucocorticosteroids

Intervention Type DRUG

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

Interventions

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Ciclesonide

Asthma Care with Alvesco

Intervention Type DRUG

Usual Care Inhaled Glucocorticosteroids

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

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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"Altana Pharma/Nycomed"

Abbotsford, , Canada

Site Status

"Altana Pharma/Nycomed"

Ajax, , Canada

Site Status

"Altana Pharma/Nycomed"

Alma, , Canada

Site Status

"Altana Pharma/Nycomed"

Anjou, , Canada

Site Status

"Altana Pharma/Nycomed"

Anjou, , Canada

Site Status

"Altana Pharma/Nycomed"

Barrie, , Canada

Site Status

"Altana Pharma/Nycomed"

Brampton, , Canada

Site Status

"Altana Pharma/Nycomed"

Brampton, , Canada

Site Status

"Altana Pharma/Nycomed"

Brampton, , Canada

Site Status

"Altana Pharma/Nycomed"

Brampton, , Canada

Site Status

"Altana Pharma/Nycomed"

Brampton, , Canada

Site Status

"Altana Pharma/Nycomed"

Brossard, , Canada

Site Status

"Altana Pharma/Nycomed"

Burnaby, , Canada

Site Status

"Altana Pharma/Nycomed"

Burnaby, , Canada

Site Status

"Altana Pharma/Nycomed"

Cacouna, , Canada

Site Status

"Altana Pharma/Nycomed"

Calgary, , Canada

Site Status

"Altana Pharma/Nycomed"

Calgary, , Canada

Site Status

"Altana Pharma/Nycomed"

Calgary, , Canada

Site Status

"Altana Pharma/Nycomed"

Calgary, , Canada

Site Status

"Altana Pharma/Nycomed"

Calgary, , Canada

Site Status

"Altana Pharma/Nycomed"

Calgary, , Canada

Site Status

"Altana Pharma/Nycomed"

Calgary, , Canada

Site Status

"Altana Pharma/Nycomed"

Calgary, , Canada

Site Status

"Altana Pharma/Nycomed"

Cambridge, , Canada

Site Status

"Altana Pharma/Nycomed"

Collingwood, , Canada

Site Status

"Altana Pharma/Nycomed"

Conception Bay S, , Canada

Site Status

"Altana Pharma/Nycomed"

Cornwall, , Canada

Site Status

"Altana Pharma/Nycomed"

Corunna, , Canada

Site Status

"Altana Pharma/Nycomed"

Courcelette, , Canada

Site Status

"Altana Pharma/Nycomed"

Delta, , Canada

Site Status

"Altana Pharma/Nycomed"

Delta, , Canada

Site Status

"Altana Pharma/Nycomed"

Dolbeau-Mistassini, , Canada

Site Status

"Altana Pharma/Nycomed"

Edmonton, , Canada

Site Status

"Altana Pharma/Nycomed"

Etobicoke, , Canada

Site Status

"Altana Pharma/Nycomed"

Fort Erie, , Canada

Site Status

"Altana Pharma/Nycomed"

Gatineau, , Canada

Site Status

"Altana Pharma/Nycomed"

Gatineau, , Canada

Site Status

"Altana Pharma/Nycomed"

Gatineau, , Canada

Site Status

"Altana Pharma/Nycomed"

Gatineau, , Canada

Site Status

"Altana Pharma/Nycomed"

Gatineau, , Canada

Site Status

"Altana Pharma/Nycomed"

Gatineau, , Canada

Site Status

"Altana Pharma/Nycomed"

Gatineau (Sector Hull), , Canada

Site Status

"Altana Pharma/Nycomed"

Grand Falls, , Canada

Site Status

"Altana Pharma/Nycomed"

Greater Sudbury, , Canada

Site Status

"Altana Pharma/Nycomed"

Greater Sudbury, , Canada

Site Status

"Altana Pharma/Nycomed"

Halifax, , Canada

Site Status

"Altana Pharma/Nycomed"

Harrow, , Canada

Site Status

"Altana Pharma/Nycomed"

Hastings, , Canada

Site Status

"Altana Pharma/Nycomed"

Hull, , Canada

Site Status

"Altana Pharma/Nycomed"

Hull, , Canada

Site Status

"Altana Pharma/Nycomed"

Joliette, , Canada

Site Status

"Altana Pharma/Nycomed"

Joliette, , Canada

Site Status

"Altana Pharma/Nycomed"

Jonquière, , Canada

Site Status

"Altana Pharma/Nycomed"

Kamloops, , Canada

Site Status

"Altana Pharma/Nycomed"

Kentville, , Canada

Site Status

"Altana Pharma/Nycomed"

Keswick, , Canada

Site Status

"Altana Pharma/Nycomed"

Kingston, , Canada

Site Status

"Altana Pharma/Nycomed"

Kirkland, , Canada

Site Status

"Altana Pharma/Nycomed"

LaSalle, , Canada

Site Status

"Altana Pharma/Nycomed"

LaSalle, , Canada

Site Status

"Altana Pharma/Nycomed"

Laval, , Canada

Site Status

"Altana Pharma/Nycomed"

London, , Canada

Site Status

"Altana Pharma/Nycomed"

London, , Canada

Site Status

"Altana Pharma/Nycomed"

London, , Canada

Site Status

"Altana Pharma/Nycomed"

Milton, , Canada

Site Status

"Altana Pharma/Nycomed"

Mississauga, , Canada

Site Status

"Altana Pharma/Nycomed"

Mississauga, , Canada

Site Status

"Altana Pharma/Nycomed"

Mississauga, , Canada

Site Status

"Altana Pharma/Nycomed"

Mississauga, , Canada

Site Status

"Altana Pharma/Nycomed"

Mississauga, , Canada

Site Status

"Altana Pharma/Nycomed"

Mississauga, , Canada

Site Status

"Altana Pharma/Nycomed"

Moncton, , Canada

Site Status

"Altana Pharma/Nycomed"

Montreal, , Canada

Site Status

"Altana Pharma/Nycomed"

Montreal, , Canada

Site Status

"Altana Pharma/Nycomed"

Montreal, , Canada

Site Status

"Altana Pharma/Nycomed"

Montreal, , Canada

Site Status

"Altana Pharma/Nycomed"

Montreal, , Canada

Site Status

"Altana Pharma/Nycomed"

Montreal, , Canada

Site Status

"Altana Pharma/Nycomed"

Montreal, , Canada

Site Status

"Altana Pharma/Nycomed"

Montreal, , Canada

Site Status

"Altana Pharma/Nycomed"

Mount Pearl, , Canada

Site Status

"Altana Pharma/Nycomed"

Mount Pearl, , Canada

Site Status

"Altana Pharma/Nycomed"

Niagara Falls, , Canada

Site Status

"Altana Pharma/Nycomed"

North Bay, , Canada

Site Status

"Altana Pharma/Nycomed"

North Sydney, , Canada

Site Status

"Altana Pharma/Nycomed"

North Vancouver, , Canada

Site Status

"Altana Pharma/Nycomed"

North Vancouver, , Canada

Site Status

"Altana Pharma/Nycomed"

North Vancouver, , Canada

Site Status

"Altana Pharma/Nycomed"

North York, , Canada

Site Status

"Altana Pharma/Nycomed"

Oakville, , Canada

Site Status

"Altana Pharma/Nycomed"

Oshawa, , Canada

Site Status

"Altana Pharma/Nycomed"

Oshawa, , Canada

Site Status

"Altana Pharma/Nycomed"

Ottawa, , Canada

Site Status

"Altana Pharma/Nycomed"

Ottawa, , Canada

Site Status

"Altana Pharma/Nycomed"

Ottawa, , Canada

Site Status

"Altana Pharma/Nycomed"

Penticton, , Canada

Site Status

"Altana Pharma/Nycomed"

Penticton, , Canada

Site Status

"Altana Pharma/Nycomed"

Perth-Andover, , Canada

Site Status

"Altana Pharma/Nycomed"

Point Edward, , Canada

Site Status

"Altana Pharma/Nycomed"

Pointe-Claire, , Canada

Site Status

"Altana Pharma/Nycomed"

Princeville, , Canada

Site Status

"Altana Pharma/Nycomed"

Québec, , Canada

Site Status

"Altana Pharma/Nycomed"

Québec, , Canada

Site Status

"Altana Pharma/Nycomed"

Québec, , Canada

Site Status

"Altana Pharma/Nycomed"

Red Deer, , Canada

Site Status

"Altana Pharma/Nycomed"

Regina, , Canada

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"Altana Pharma/Nycomed"

Regina, , Canada

Site Status

"Altana Pharma/Nycomed"

Repentigny, , Canada

Site Status

"Altana Pharma/Nycomed"

Richmond, , Canada

Site Status

"Altana Pharma/Nycomed"

Richmond Hill, , Canada

Site Status

"Altana Pharma/Nycomed"

Rimouski, , Canada

Site Status

"Altana Pharma/Nycomed"

Roxton Pond, , Canada

Site Status

"Altana Pharma/Nycomed"

Saint John, , Canada

Site Status

"Altana Pharma/Nycomed"

Saint Romuald, , Canada

Site Status

"Altana Pharma/Nycomed"

Saint-Jérôme, , Canada

Site Status

"Altana Pharma/Nycomed"

Saint-Léonard, , Canada

Site Status

"Altana Pharma/Nycomed"

Saint-Pie, , Canada

Site Status

"Altana Pharma/Nycomed"

Sainte-Catherine, , Canada

Site Status

"Altana Pharma/Nycomed"

Sarnia, , Canada

Site Status

"Altana Pharma/Nycomed"

Saskatoon, , Canada

Site Status

"Altana Pharma/Nycomed"

Saskatoon, , Canada

Site Status

"Altana Pharma/Nycomed"

Scarborough, , Canada

Site Status

"Altana Pharma/Nycomed"

Scarborough, , Canada

Site Status

"Altana Pharma/Nycomed"

Sherbrooke, , Canada

Site Status

"Altana Pharma/Nycomed"

Shubenacadie, , Canada

Site Status

"Altana Pharma/Nycomed"

St-Bruno, , Canada

Site Status

"Altana Pharma/Nycomed"

St-Jean-sur-Richel, , Canada

Site Status

"Altana Pharma/Nycomed"

St. Catharines, , Canada

Site Status

"Altana Pharma/Nycomed"

St. John's, , Canada

Site Status

"Altana Pharma/Nycomed"

St. John's, , Canada

Site Status

"Altana Pharma/Nycomed"

St. John's, , Canada

Site Status

"Altana Pharma/Nycomed"

St. John's, , Canada

Site Status

"Altana Pharma/Nycomed"

Ste Anne de Bellev, , Canada

Site Status

"Altana Pharma/Nycomed"

Stirling, , Canada

Site Status

"Altana Pharma/Nycomed"

Stouffville, , Canada

Site Status

"Altana Pharma/Nycomed"

Surrey, , Canada

Site Status

"Altana Pharma/Nycomed"

Surrey, , Canada

Site Status

"Altana Pharma/Nycomed"

Surrey, , Canada

Site Status

"Altana Pharma/Nycomed"

Surrey, , Canada

Site Status

"Altana Pharma/Nycomed"

Surrey, , Canada

Site Status

"Altana Pharma/Nycomed"

Sydney Mines, , Canada

Site Status

"Altana Pharma/Nycomed"

Thetford-Mines, , Canada

Site Status

"Altana Pharma/Nycomed"

Thornhill, , Canada

Site Status

"Altana Pharma/Nycomed"

Thunder Bay, , Canada

Site Status

"Altana Pharma/Nycomed"

Thunder Bay, , Canada

Site Status

"Altana Pharma/Nycomed"

Toronto, , Canada

Site Status

"Altana Pharma/Nycomed"

Toronto, , Canada

Site Status

"Altana Pharma/Nycomed"

Toronto, , Canada

Site Status

"Altana Pharma/Nycomed"

Toronto, , Canada

Site Status

"Altana Pharma/Nycomed"

Toronto, , Canada

Site Status

"Altana Pharma/Nycomed"

Toronto, , Canada

Site Status

"Altana Pharma/Nycomed"

Toronto, , Canada

Site Status

"Altana Pharma/Nycomed"

Toronto, , Canada

Site Status

"Altana Pharma/Nycomed"

Toronto, , Canada

Site Status

"Altana Pharma/Nycomed"

Vancouver, , Canada

Site Status

"Altana Pharma/Nycomed"

Vancouver, , Canada

Site Status

"Altana Pharma/Nycomed"

Vancouver, , Canada

Site Status

"Altana Pharma/Nycomed"

Vancouver, , Canada

Site Status

"Altana Pharma/Nycomed"

Vancouver, , Canada

Site Status

"Altana Pharma/Nycomed"

Verdun, , Canada

Site Status

"Altana Pharma/Nycomed"

Verdun, , Canada

Site Status

"Altana Pharma/Nycomed"

Victoria, , Canada

Site Status

"Altana Pharma/Nycomed"

West Vancouver, , Canada

Site Status

"Altana Pharma/Nycomed"

Westmount, , Canada

Site Status

"Altana Pharma/Nycomed"

Whitby, , Canada

Site Status

"Altana Pharma/Nycomed"

Windsor, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Winnipeg, , Canada

Site Status

"Altana Pharma/Nycomed"

Woodstock, , Canada

Site Status

"Altana Pharma/Nycomed"

Woodstock, , Canada

Site Status

"Altana Pharma/Nycomed"

York, , Canada

Site Status

"Altana Pharma/Nycomed"

York, , Canada

Site Status

Countries

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Canada

Other Identifiers

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BY9010/CA-102

Identifier Type: -

Identifier Source: org_study_id

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