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

NCT00404547 | Completed Phase 4 Results

• 1 other identifier: BY9010/CA-102
• Study Type: interventional
• Target: 1,121
• Locations: 1 country
• Sites: 186

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.

Conditions

Asthma

Keywords

Asthma; Alvesco®; Ciclesonide

Outcome Measures

Primary Outcomes (1)

• Change in Mean of Total Score of Asthma Control Questionnaire (ACQ)

  The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome).

  At the middle and end of the 12 week treatment period

Secondary Outcomes (3)

• Change in Patient Assessment of Asthma Control

  At baseline and at week 12

• Assessment of Patient Compliance During the Study

  12 weeks

• Assessment of Patient Treatment Satisfaction

  12 weeks

Study Arms (2)

Alvesco

ACTIVE COMPARATOR

Alvesco 320mcg / Alvesco 640mcg

Drug: Ciclesonide

Usual Care

ACTIVE COMPARATOR

Drug: Usual Care Inhaled Glucocorticosteroids

Interventions

Ciclesonide DRUG

Asthma Care with Alvesco

Alvesco

Usual Care Inhaled Glucocorticosteroids DRUG

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (186)

"Altana Pharma/Nycomed"

Abbotsford, V2T 3S4, Canada

Location

"Altana Pharma/Nycomed"

Ajax, L1S 2H6, Canada

Location

"Altana Pharma/Nycomed"

Alma, G8E 2K2, Canada

Location

"Altana Pharma/Nycomed"

Anjou, H1J 1G4, Canada

Location

"Altana Pharma/Nycomed"

Anjou, H1K 1P2, Canada

Location

"Altana Pharma/Nycomed"

Barrie, L4N 8Z1, Canada

Location

"Altana Pharma/Nycomed"

Brampton, L6T 3J1, Canada

Location

"Altana Pharma/Nycomed"

Brampton, L6W 3X4, Canada

Location

"Altana Pharma/Nycomed"

Brampton, L6X 5E9, Canada

Location

"Altana Pharma/Nycomed"

Brampton, L6Z 0A4, Canada

Location

"Altana Pharma/Nycomed"

Brampton, L6Z 2W1, Canada

Location

"Altana Pharma/Nycomed"

Brossard, J4Z 2K9, Canada

Location

"Altana Pharma/Nycomed"

Burnaby, V5G 3Y3, Canada

Location

"Altana Pharma/Nycomed"

Burnaby, V5H 4M4, Canada

Location

"Altana Pharma/Nycomed"

Cacouna, G0L 1G0, Canada

Location

"Altana Pharma/Nycomed"

Calgary, T2C 2E7, Canada

Location

"Altana Pharma/Nycomed"

Calgary, T2E 2S9, Canada

Location

"Altana Pharma/Nycomed"

Calgary, T2J 0N2, Canada

Location

"Altana Pharma/Nycomed"

Calgary, T2L 0S3, Canada

Location

"Altana Pharma/Nycomed"

Calgary, T2M 0H5, Canada

Location

"Altana Pharma/Nycomed"

Calgary, T2X 3X7, Canada

Location

"Altana Pharma/Nycomed"

Calgary, T3A 5H5, Canada

Location

"Altana Pharma/Nycomed"

Calgary, T3C 3P1, Canada

Location

"Altana Pharma/Nycomed"

Cambridge, N3C 3R3, Canada

Location

"Altana Pharma/Nycomed"

Collingwood, L9Y 1K4, Canada

Location

"Altana Pharma/Nycomed"

Conception Bay S, A1W 3A6, Canada

Location

"Altana Pharma/Nycomed"

Cornwall, K6J 3V9, Canada

Location

"Altana Pharma/Nycomed"

Corunna, N0N 1G0, Canada

Location

"Altana Pharma/Nycomed"

Courcelette, G0A 1R1, Canada

Location

"Altana Pharma/Nycomed"

Delta, V4E 1Z7, Canada

Location

"Altana Pharma/Nycomed"

Delta, V4K 2K5, Canada

Location

"Altana Pharma/Nycomed"

Dolbeau-Mistassini, G8L 5J8, Canada

Location

"Altana Pharma/Nycomed"

Edmonton, T5T 2K6, Canada

Location

"Altana Pharma/Nycomed"

Etobicoke, M9V 5G5, Canada

Location

"Altana Pharma/Nycomed"

Fort Erie, L2A 1Z3, Canada

Location

"Altana Pharma/Nycomed"

Gatineau, J8P 1E3, Canada

Location

"Altana Pharma/Nycomed"

Gatineau, J8Y 1W7, Canada

Location

"Altana Pharma/Nycomed"

Gatineau, J8Y 2E2, Canada

Location

"Altana Pharma/Nycomed"

Gatineau, J8Y 6S9, Canada

Location

"Altana Pharma/Nycomed"

Gatineau, J8Z 1J1, Canada

Location

"Altana Pharma/Nycomed"

Gatineau, J9H 6A6, Canada

Location

"Altana Pharma/Nycomed"

Gatineau (Sector Hull), J8Y 2E2, Canada

Location

"Altana Pharma/Nycomed"

Grand Falls, E3Y 1A5, Canada

Location

"Altana Pharma/Nycomed"

Greater Sudbury, P3A 2A3, Canada

Location

"Altana Pharma/Nycomed"

Greater Sudbury, P3E 3C6, Canada

Location

"Altana Pharma/Nycomed"

Halifax, B3H 2E8, Canada

Location

"Altana Pharma/Nycomed"

Harrow, N0R 1G0, Canada

Location

"Altana Pharma/Nycomed"

Hastings, K0L 1Y0, Canada

Location

"Altana Pharma/Nycomed"

Hull, J8Y 2E2, Canada

Location

"Altana Pharma/Nycomed"

Hull, J8Y 6S9, Canada

Location

"Altana Pharma/Nycomed"

Joliette, J6E 3E4, Canada

Location

"Altana Pharma/Nycomed"

Joliette, J6E 6J2, Canada

Location

"Altana Pharma/Nycomed"

Jonquière, G7X 9Y4, Canada

Location

"Altana Pharma/Nycomed"

Kamloops, V2C 5R9, Canada

Location

"Altana Pharma/Nycomed"

Kentville, B4N 1M6, Canada

Location

"Altana Pharma/Nycomed"

Keswick, L4P 2C9, Canada

Location

"Altana Pharma/Nycomed"

Kingston, K7L 1G1, Canada

Location

"Altana Pharma/Nycomed"

Kirkland, H9J 2W2, Canada

Location

"Altana Pharma/Nycomed"

LaSalle, H8N 1T5, Canada

Location

"Altana Pharma/Nycomed"

LaSalle, H8N 1X9, Canada

Location

"Altana Pharma/Nycomed"

Laval, H7R 5E8, Canada

Location

"Altana Pharma/Nycomed"

London, N6A 5R9, Canada

Location

"Altana Pharma/Nycomed"

London, N6H 4V6, Canada

Location

"Altana Pharma/Nycomed"

London, N6P 1A9, Canada

Location

"Altana Pharma/Nycomed"

Milton, L9T 0H7, Canada

Location

"Altana Pharma/Nycomed"

Mississauga, L4Z 3J1, Canada

Location

"Altana Pharma/Nycomed"

Mississauga, L5B 3A8, Canada

Location

"Altana Pharma/Nycomed"

Mississauga, L5M 2V8, Canada

Location

"Altana Pharma/Nycomed"

Mississauga, L5N 6S5, Canada

Location

"Altana Pharma/Nycomed"

Mississauga, L5N6S5, Canada

Location

"Altana Pharma/Nycomed"

Mississauga, L5R 3K7, Canada

Location

"Altana Pharma/Nycomed"

Moncton, E1G 1A7, Canada

Location

"Altana Pharma/Nycomed"

Montreal, H1T 1G3, Canada

Location

"Altana Pharma/Nycomed"

Montreal, H1V1X5, Canada

Location

"Altana Pharma/Nycomed"

Montreal, H1X 1R6, Canada

Location

"Altana Pharma/Nycomed"

Montreal, H2M 1S5, Canada

Location

"Altana Pharma/Nycomed"

Montreal, H3L 1V2, Canada

Location

"Altana Pharma/Nycomed"

Montreal, H3M 3E2, Canada

Location

"Altana Pharma/Nycomed"

Montreal, H3T 1Y6, Canada

Location

"Altana Pharma/Nycomed"

Montreal, H4V 2R8, Canada

Location

"Altana Pharma/Nycomed"

Mount Pearl, A1N 2C1, Canada

Location

"Altana Pharma/Nycomed"

Mount Pearl, A1N 5B6, Canada

Location

"Altana Pharma/Nycomed"

Niagara Falls, L2E 7H1, Canada

Location

"Altana Pharma/Nycomed"

North Bay, P1B 6L1, Canada

Location

"Altana Pharma/Nycomed"

North Sydney, B2A 3M4, Canada

Location

"Altana Pharma/Nycomed"

North Vancouver, V7L 2L4, Canada

Location

"Altana Pharma/Nycomed"

North Vancouver, V7L 2N3, Canada

Location

"Altana Pharma/Nycomed"

North Vancouver, V7M 2K2, Canada

Location

"Altana Pharma/Nycomed"

North York, M3N 2L2, Canada

Location

"Altana Pharma/Nycomed"

Oakville, L6K1J6, Canada

Location

"Altana Pharma/Nycomed"

Oshawa, L1H 7K4, Canada

Location

"Altana Pharma/Nycomed"

Oshawa, L1J 2K9, Canada

Location

"Altana Pharma/Nycomed"

Ottawa, K1K 4L2, Canada

Location

"Altana Pharma/Nycomed"

Ottawa, K1L 6N6, Canada

Location

"Altana Pharma/Nycomed"

Ottawa, K1Y 4G2, Canada

Location

"Altana Pharma/Nycomed"

Penticton, V2A 5C8, Canada

Location

"Altana Pharma/Nycomed"

Penticton, V2A 5H8, Canada

Location

"Altana Pharma/Nycomed"

Perth-Andover, E7H 5H4, Canada

Location

"Altana Pharma/Nycomed"

Point Edward, N7V 1X4, Canada

Location

"Altana Pharma/Nycomed"

Pointe-Claire, H9R 3J1, Canada

Location

"Altana Pharma/Nycomed"

Princeville, G6L 5A3, Canada

Location

"Altana Pharma/Nycomed"

Québec, G1G 4A2, Canada

Location

"Altana Pharma/Nycomed"

Québec, G1H 6E1, Canada

Location

"Altana Pharma/Nycomed"

Québec, G2L 1M1, Canada

Location

"Altana Pharma/Nycomed"

Red Deer, T4R 3J5, Canada

Location

"Altana Pharma/Nycomed"

Regina, S4P 1Y5, Canada

Location

"Altana Pharma/Nycomed"

Regina, S4S 3R2, Canada

Location

"Altana Pharma/Nycomed"

Repentigny, G6A 2T8, Canada

Location

"Altana Pharma/Nycomed"

Richmond, V7C 3V3, Canada

Location

"Altana Pharma/Nycomed"

Richmond Hill, L4C 2N9, Canada

Location

"Altana Pharma/Nycomed"

Rimouski, G5L 9A8, Canada

Location

"Altana Pharma/Nycomed"

Roxton Pond, J0E1Z0, Canada

Location

"Altana Pharma/Nycomed"

Saint John, E2K 2T8, Canada

Location

"Altana Pharma/Nycomed"

Saint Romuald, G6W 5M6, Canada

Location

"Altana Pharma/Nycomed"

Saint-Jérôme, J7Z 1Y5, Canada

Location

"Altana Pharma/Nycomed"

Saint-Léonard, H1R 2T6, Canada

Location

"Altana Pharma/Nycomed"

Saint-Pie, J0H 1W0, Canada

Location

"Altana Pharma/Nycomed"

Sainte-Catherine, J5C 1A8, Canada

Location

"Altana Pharma/Nycomed"

Sarnia, N7T 4X3, Canada

Location

"Altana Pharma/Nycomed"

Saskatoon, S7K 3H3, Canada

Location

"Altana Pharma/Nycomed"

Saskatoon, S7L 2W1, Canada

Location

"Altana Pharma/Nycomed"

Scarborough, M1N1W8, Canada

Location

"Altana Pharma/Nycomed"

Scarborough, M2K 2Z3, Canada

Location

"Altana Pharma/Nycomed"

Sherbrooke, J1G 1A4, Canada

Location

"Altana Pharma/Nycomed"

Shubenacadie, B0N 2H0, Canada

Location

"Altana Pharma/Nycomed"

St-Bruno, G0W 2L0, Canada

Location

"Altana Pharma/Nycomed"

St-Jean-sur-Richel, J2W 1J1, Canada

Location

"Altana Pharma/Nycomed"

St. Catharines, L2R 7P3, Canada

Location

"Altana Pharma/Nycomed"

St. John's, A1A 4Z7, Canada

Location

"Altana Pharma/Nycomed"

St. John's, A1E 2C2, Canada

Location

"Altana Pharma/Nycomed"

St. John's, A1E 2E2, Canada

Location

"Altana Pharma/Nycomed"

St. John's, A1E 2X3, Canada

Location

"Altana Pharma/Nycomed"

Ste Anne de Bellev, H9X 1L8, Canada

Location

"Altana Pharma/Nycomed"

Stirling, K0K 3E0, Canada

Location

"Altana Pharma/Nycomed"

Stouffville, L4A 4H8, Canada

Location

"Altana Pharma/Nycomed"

Surrey, V3R 3P1, Canada

Location

"Altana Pharma/Nycomed"

Surrey, V3R 4E5, Canada

Location

"Altana Pharma/Nycomed"

Surrey, V3R 6N7, Canada

Location

"Altana Pharma/Nycomed"

Surrey, V3T 2X6, Canada

Location

"Altana Pharma/Nycomed"

Surrey, V3V 4B5, Canada

Location

"Altana Pharma/Nycomed"

Sydney Mines, B1V 2Y2, Canada

Location

"Altana Pharma/Nycomed"

Thetford-Mines, G6G 6H1, Canada

Location

"Altana Pharma/Nycomed"

Thornhill, L4J 1E9, Canada

Location

"Altana Pharma/Nycomed"

Thunder Bay, P7E 5H7, Canada

Location

"Altana Pharma/Nycomed"

Thunder Bay, P7E 6E7, Canada

Location

"Altana Pharma/Nycomed"

Toronto, M2M2R1, Canada

Location

"Altana Pharma/Nycomed"

Toronto, M4K 3Z1, Canada

Location

"Altana Pharma/Nycomed"

Toronto, M4L 1E9, Canada

Location

"Altana Pharma/Nycomed"

Toronto, M4M 1J5, Canada

Location

"Altana Pharma/Nycomed"

Toronto, M4P 1P2, Canada

Location

"Altana Pharma/Nycomed"

Toronto, M4X 1W4, Canada

Location

"Altana Pharma/Nycomed"

Toronto, M5M 1B2, Canada

Location

"Altana Pharma/Nycomed"

Toronto, M6C 1A3, Canada

Location

"Altana Pharma/Nycomed"

Toronto, M9P 3A9, Canada

Location

"Altana Pharma/Nycomed"

Vancouver, V5L 4T5, Canada

Location

"Altana Pharma/Nycomed"

Vancouver, V5N 5K4, Canada

Location

"Altana Pharma/Nycomed"

Vancouver, V5P 3X5, Canada

Location

"Altana Pharma/Nycomed"

Vancouver, V5P 3Y2, Canada

Location

"Altana Pharma/Nycomed"

Vancouver, V5Z 4E1, Canada

Location

"Altana Pharma/Nycomed"

Verdun, H4G 3E7, Canada

Location

"Altana Pharma/Nycomed"

Verdun, H4H 1M1, Canada

Location

"Altana Pharma/Nycomed"

Victoria, V8N 1A4, Canada

Location

"Altana Pharma/Nycomed"

West Vancouver, V7V 3S8, Canada

Location

"Altana Pharma/Nycomed"

Westmount, H3Z1X5, Canada

Location

"Altana Pharma/Nycomed"

Whitby, L1R 3E1, Canada

Location

"Altana Pharma/Nycomed"

Windsor, B0N 2T0, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R2C 1R2, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R2E 0B8, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R2H OR8, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R2J 4A7, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R2M 2X9, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R2M 2Z5, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R2M 3T2, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R2M 5L9, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R2N 1Z3, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R2V 2C2, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R2V 3C4, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R3C 0N2, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R3C 3J5, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R3E 0E1, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R3M 0Y4, Canada

Location

"Altana Pharma/Nycomed"

Winnipeg, R3M2A6, Canada

Location

"Altana Pharma/Nycomed"

Woodstock, N4S 4G3, Canada

Location

"Altana Pharma/Nycomed"

Woodstock, N4S 4H4, Canada

Location

"Altana Pharma/Nycomed"

York, M9N 1X7, Canada

Location

"Altana Pharma/Nycomed"

York, M9N 2A7, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: AstraZeneca Clinical Study Information Center
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 28, 2006
• Study Start: November 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 1, 2017
• Results First Posted: March 26, 2010

Record last verified: 2016-09

Locations

CA (186)