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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Ciclesonide; Drug: Usual Care Inhaled Glucocorticosteroids

• Study Type: Interventional
• Enrollment (Actual): 1121
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Abbotsford, Canada, V2T 3S4
    • "Altana Pharma/Nycomed"
  • Ajax, Canada, L1S 2H6
    • "Altana Pharma/Nycomed"
  • Alma, Canada, G8E 2K2
    • "Altana Pharma/Nycomed"
  • Anjou, Canada, H1J 1G4
    • "Altana Pharma/Nycomed"
  • Anjou, Canada, H1K 1P2
    • "Altana Pharma/Nycomed"
  • Barrie, Canada, L4N 8Z1
    • "Altana Pharma/Nycomed"
  • Brampton, Canada, L6T 3J1
    • "Altana Pharma/Nycomed"
  • Brampton, Canada, L6W 3X4
    • "Altana Pharma/Nycomed"
  • Brampton, Canada, L6X 5E9
    • "Altana Pharma/Nycomed"
  • Brampton, Canada, L6Z 0A4
    • "Altana Pharma/Nycomed"
  • Brampton, Canada, L6Z 2W1
    • "Altana Pharma/Nycomed"
  • Brossard, Canada, J4Z 2K9
    • "Altana Pharma/Nycomed"
  • Burnaby, Canada, V5G 3Y3
    • "Altana Pharma/Nycomed"
  • Burnaby, Canada, V5H 4M4
    • "Altana Pharma/Nycomed"
  • Cacouna, Canada, G0L 1G0
    • "Altana Pharma/Nycomed"
  • Calgary, Canada, T2C 2E7
    • "Altana Pharma/Nycomed"
  • Calgary, Canada, T2E 2S9
    • "Altana Pharma/Nycomed"
  • Calgary, Canada, T2J 0N2
    • "Altana Pharma/Nycomed"
  • Calgary, Canada, T2L 0S3
    • "Altana Pharma/Nycomed"
  • Calgary, Canada, T2M 0H5
    • "Altana Pharma/Nycomed"
  • Calgary, Canada, T2X 3X7
    • "Altana Pharma/Nycomed"
  • Calgary, Canada, T3A 5H5
    • "Altana Pharma/Nycomed"
  • Calgary, Canada, T3C 3P1
    • "Altana Pharma/Nycomed"
  • Cambridge, Canada, N3C 3R3
    • "Altana Pharma/Nycomed"
  • Collingwood, Canada, L9Y 1K4
    • "Altana Pharma/Nycomed"
  • Conception Bay S, Canada, A1W 3A6
    • "Altana Pharma/Nycomed"
  • Cornwall, Canada, K6J 3V9
    • "Altana Pharma/Nycomed"
  • Corunna, Canada, N0N 1G0
    • "Altana Pharma/Nycomed"
  • Courcelette, Canada, G0A 1R1
    • "Altana Pharma/Nycomed"
  • Delta, Canada, V4E 1Z7
    • "Altana Pharma/Nycomed"
  • Delta, Canada, V4K 2K5
    • "Altana Pharma/Nycomed"
  • Dolbeau-Mistassini, Canada, G8L 5J8
    • "Altana Pharma/Nycomed"
  • Edmonton, Canada, T5T 2K6
    • "Altana Pharma/Nycomed"
  • Etobicoke, Canada, M9V 5G5
    • "Altana Pharma/Nycomed"
  • Fort Erie, Canada, L2A 1Z3
    • "Altana Pharma/Nycomed"
  • Gatineau, Canada, J8P 1E3
    • "Altana Pharma/Nycomed"
  • Gatineau, Canada, J8Y 1W7
    • "Altana Pharma/Nycomed"
  • Gatineau, Canada, J8Y 2E2
    • "Altana Pharma/Nycomed"
  • Gatineau, Canada, J8Y 6S9
    • "Altana Pharma/Nycomed"
  • Gatineau, Canada, J8Z 1J1
    • "Altana Pharma/Nycomed"
  • Gatineau, Canada, J9H 6A6
    • "Altana Pharma/Nycomed"
  • Gatineau (Sector Hull), Canada, J8Y 2E2
    • "Altana Pharma/Nycomed"
  • Grand Falls, Canada, E3Y 1A5
    • "Altana Pharma/Nycomed"
  • Halifax, Canada, B3H 2E8
    • "Altana Pharma/Nycomed"
  • Harrow, Canada, N0R 1G0
    • "Altana Pharma/Nycomed"
  • Hastings, Canada, K0L 1Y0
    • "Altana Pharma/Nycomed"
  • Hull, Canada, J8Y 2E2
    • "Altana Pharma/Nycomed"
  • Hull, Canada, J8Y 6S9
    • "Altana Pharma/Nycomed"
  • Joliette, Canada, J6E 3E4
    • "Altana Pharma/Nycomed"
  • Joliette, Canada, J6E 6J2
    • "Altana Pharma/Nycomed"
  • Jonquiere, Canada, G7X 9Y4
    • "Altana Pharma/Nycomed"
  • Kamloops, Canada, V2C 5R9
    • "Altana Pharma/Nycomed"
  • Kentville, Canada, B4N 1M6
    • "Altana Pharma/Nycomed"
  • Keswick, Canada, L4P 2C9
    • "Altana Pharma/Nycomed"
  • Kingston, Canada, K7L 1G1
    • "Altana Pharma/Nycomed"
  • Kirkland, Canada, H9J 2W2
    • "Altana Pharma/Nycomed"
  • Lasalle, Canada, H8N 1T5
    • "Altana Pharma/Nycomed"
  • Lasalle, Canada, H8N 1X9
    • "Altana Pharma/Nycomed"
  • Laval, Canada, H7R 5E8
    • "Altana Pharma/Nycomed"
  • London, Canada, N6A 5R9
    • "Altana Pharma/Nycomed"
  • London, Canada, N6H 4V6
    • "Altana Pharma/Nycomed"
  • London, Canada, N6P 1A9
    • "Altana Pharma/Nycomed"
  • Milton, Canada, L9T 0H7
    • "Altana Pharma/Nycomed"
  • Mississauga, Canada, L4Z 3J1
    • "Altana Pharma/Nycomed"
  • Mississauga, Canada, L5B 3A8
    • "Altana Pharma/Nycomed"
  • Mississauga, Canada, L5M 2V8
    • "Altana Pharma/Nycomed"
  • Mississauga, Canada, L5N 6S5
    • "Altana Pharma/Nycomed"
  • Mississauga, Canada, L5N6S5
    • "Altana Pharma/Nycomed"
  • Mississauga, Canada, L5R 3K7
    • "Altana Pharma/Nycomed"
  • Moncton, Canada, E1G 1A7
    • "Altana Pharma/Nycomed"
  • Montreal, Canada, H1T 1G3
    • "Altana Pharma/Nycomed"
  • Montreal, Canada, H1V1X5
    • "Altana Pharma/Nycomed"
  • Montreal, Canada, H1X 1R6
    • "Altana Pharma/Nycomed"
  • Montreal, Canada, H2M 1S5
    • "Altana Pharma/Nycomed"
  • Montreal, Canada, H3L 1V2
    • "Altana Pharma/Nycomed"
  • Montreal, Canada, H3M 3E2
    • "Altana Pharma/Nycomed"
  • Montreal, Canada, H3T 1Y6
    • "Altana Pharma/Nycomed"
  • Montreal, Canada, H4V 2R8
    • "Altana Pharma/Nycomed"
  • Mount Pearl, Canada, A1N 2C1
    • "Altana Pharma/Nycomed"
  • Mount Pearl, Canada, A1N 5B6
    • "Altana Pharma/Nycomed"
  • Niagara Falls, Canada, L2E 7H1
    • "Altana Pharma/Nycomed"
  • North Bay, Canada, P1B 6L1
    • "Altana Pharma/Nycomed"
  • North Sydney, Canada, B2A 3M4
    • "Altana Pharma/Nycomed"
  • North Vancouver, Canada, V7L 2L4
    • "Altana Pharma/Nycomed"
  • North Vancouver, Canada, V7L 2N3
    • "Altana Pharma/Nycomed"
  • North Vancouver, Canada, V7M 2K2
    • "Altana Pharma/Nycomed"
  • North York, Canada, M3N 2L2
    • "Altana Pharma/Nycomed"
  • Oakville, Canada, L6K1J6
    • "Altana Pharma/Nycomed"
  • Oshawa, Canada, L1H 7K4
    • "Altana Pharma/Nycomed"
  • Oshawa, Canada, L1J 2K9
    • "Altana Pharma/Nycomed"
  • Ottawa, Canada, K1K 4L2
    • "Altana Pharma/Nycomed"
  • Ottawa, Canada, K1L 6N6
    • "Altana Pharma/Nycomed"
  • Ottawa, Canada, K1Y 4G2
    • "Altana Pharma/Nycomed"
  • Penticton, Canada, V2A 5C8
    • "Altana Pharma/Nycomed"
  • Penticton, Canada, V2A 5H8
    • "Altana Pharma/Nycomed"
  • Perth Andover, Canada, E7H 5H4
    • "Altana Pharma/Nycomed"
  • Point Edward, Canada, N7V 1X4
    • "Altana Pharma/Nycomed"
  • Pointe-Claire, Canada, H9R 3J1
    • "Altana Pharma/Nycomed"
  • Princeville, Canada, G6L 5A3
    • "Altana Pharma/Nycomed"
  • Quebec, Canada, G1G 4A2
    • "Altana Pharma/Nycomed"
  • Quebec, Canada, G1H 6E1
    • "Altana Pharma/Nycomed"
  • Quebec, Canada, G2L 1M1
    • "Altana Pharma/Nycomed"
  • Red Deer, Canada, T4R 3J5
    • "Altana Pharma/Nycomed"
  • Regina, Canada, S4P 1Y5
    • "Altana Pharma/Nycomed"
  • Regina, Canada, S4S 3R2
    • "Altana Pharma/Nycomed"
  • Repentigny, Canada, G6A 2T8
    • "Altana Pharma/Nycomed"
  • Richmond, Canada, V7C 3V3
    • "Altana Pharma/Nycomed"
  • Richmond Hill, Canada, L4C 2N9
    • "Altana Pharma/Nycomed"
  • Rimouski, Canada, G5L 9A8
    • "Altana Pharma/Nycomed"
  • Roxton Pond, Canada, J0E1Z0
    • "Altana Pharma/Nycomed"
  • Saint John, Canada, E2K 2T8
    • "Altana Pharma/Nycomed"
  • Sainte-Catherine, Canada, J5C 1A8
    • "Altana Pharma/Nycomed"
  • Sarnia, Canada, N7T 4X3
    • "Altana Pharma/Nycomed"
  • Saskatoon, Canada, S7K 3H3
    • "Altana Pharma/Nycomed"
  • Saskatoon, Canada, S7L 2W1
    • "Altana Pharma/Nycomed"
  • Scarborough, Canada, M1N1W8
    • "Altana Pharma/Nycomed"
  • Scarborough, Canada, M2K 2Z3
    • "Altana Pharma/Nycomed"
  • Sherbrooke, Canada, J1G 1A4
    • "Altana Pharma/Nycomed"
  • Shubenacadie, Canada, B0N 2H0
    • "Altana Pharma/Nycomed"
  • St Bruno, Canada, G0W 2L0
    • "Altana Pharma/Nycomed"
  • St-Jean-sur-Richel, Canada, J2W 1J1
    • "Altana Pharma/Nycomed"
  • St-Jerome, Canada, J7Z 1Y5
    • "Altana Pharma/Nycomed"
  • St-Pie, Canada, J0H 1W0
    • "Altana Pharma/Nycomed"
  • St. Catharines, Canada, L2R 7P3
    • "Altana Pharma/Nycomed"
  • St. John's, Canada, A1A 4Z7
    • "Altana Pharma/Nycomed"
  • St. John's, Canada, A1E 2C2
    • "Altana Pharma/Nycomed"
  • St. John's, Canada, A1E 2E2
    • "Altana Pharma/Nycomed"
  • St. John's, Canada, A1E 2X3
    • "Altana Pharma/Nycomed"
  • St. Leonard, Canada, H1R 2T6
    • "Altana Pharma/Nycomed"
  • St. Romuald, Canada, G6W 5M6
    • "Altana Pharma/Nycomed"
  • Ste Anne De Bellev, Canada, H9X 1L8
    • "Altana Pharma/Nycomed"
  • Stirling, Canada, K0K 3E0
    • "Altana Pharma/Nycomed"
  • Stouffville, Canada, L4A 4H8
    • "Altana Pharma/Nycomed"
  • Sudbury, Canada, P3A 2A3
    • "Altana Pharma/Nycomed"
  • Sudbury, Canada, P3E 3C6
    • "Altana Pharma/Nycomed"
  • Surrey, Canada, V3R 3P1
    • "Altana Pharma/Nycomed"
  • Surrey, Canada, V3R 4E5
    • "Altana Pharma/Nycomed"
  • Surrey, Canada, V3R 6N7
    • "Altana Pharma/Nycomed"
  • Surrey, Canada, V3T 2X6
    • "Altana Pharma/Nycomed"
  • Surrey, Canada, V3V 4B5
    • "Altana Pharma/Nycomed"
  • Sydney Mines, Canada, B1V 2Y2
    • "Altana Pharma/Nycomed"
  • Thetford Mines, Canada, G6G 6H1
    • "Altana Pharma/Nycomed"
  • Thornhill, Canada, L4J 1E9
    • "Altana Pharma/Nycomed"
  • Thunder Bay, Canada, P7E 5H7
    • "Altana Pharma/Nycomed"
  • Thunder Bay, Canada, P7E 6E7
    • "Altana Pharma/Nycomed"
  • Toronto, Canada, M2M2R1
    • "Altana Pharma/Nycomed"
  • Toronto, Canada, M4K 3Z1
    • "Altana Pharma/Nycomed"
  • Toronto, Canada, M4L 1E9
    • "Altana Pharma/Nycomed"
  • Toronto, Canada, M4M 1J5
    • "Altana Pharma/Nycomed"
  • Toronto, Canada, M4P 1P2
    • "Altana Pharma/Nycomed"
  • Toronto, Canada, M4X 1W4
    • "Altana Pharma/Nycomed"
  • Toronto, Canada, M5M 1B2
    • "Altana Pharma/Nycomed"
  • Toronto, Canada, M6C 1A3
    • "Altana Pharma/Nycomed"
  • Toronto, Canada, M9P 3A9
    • "Altana Pharma/Nycomed"
  • Vancouver, Canada, V5L 4T5
    • "Altana Pharma/Nycomed"
  • Vancouver, Canada, V5N 5K4
    • "Altana Pharma/Nycomed"
  • Vancouver, Canada, V5P 3X5
    • "Altana Pharma/Nycomed"
  • Vancouver, Canada, V5P 3Y2
    • "Altana Pharma/Nycomed"
  • Vancouver, Canada, V5Z 4E1
    • "Altana Pharma/Nycomed"
  • Verdun, Canada, H4G 3E7
    • "Altana Pharma/Nycomed"
  • Verdun, Canada, H4H 1M1
    • "Altana Pharma/Nycomed"
  • Victoria, Canada, V8N 1A4
    • "Altana Pharma/Nycomed"
  • West Vancouver, Canada, V7V 3S8
    • "Altana Pharma/Nycomed"
  • Westmount, Canada, H3Z1X5
    • "Altana Pharma/Nycomed"
  • Whitby, Canada, L1R 3E1
    • "Altana Pharma/Nycomed"
  • Windsor, Canada, B0N 2T0
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R2C 1R2
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R2E 0B8
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R2H OR8
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R2J 4A7
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R2M 2X9
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R2M 2Z5
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R2M 3T2
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R2M 5L9
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R2N 1Z3
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R2V 2C2
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R2V 3C4
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R3C 0N2
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R3C 3J5
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R3E 0E1
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R3M 0Y4
    • "Altana Pharma/Nycomed"
  • Winnipeg, Canada, R3M2A6
    • "Altana Pharma/Nycomed"
  • Woodstock, Canada, N4S 4G3
    • "Altana Pharma/Nycomed"
  • Woodstock, Canada, N4S 4H4
    • "Altana Pharma/Nycomed"
  • York, Canada, M9N 1X7
    • "Altana Pharma/Nycomed"
  • York, Canada, M9N 2A7
    • "Altana Pharma/Nycomed"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Active Comparator: Alvesco; Alvesco 320mcg / Alvesco 640mcg	Drug: Ciclesonide; Asthma Care with Alvesco

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Assessment of Asthma Control	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".	At baseline and at week 12
Assessment of Patient Compliance During the Study		12 weeks
Assessment of Patient Treatment Satisfaction		12 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: November 27, 2006
• First Submitted That Met QC Criteria: November 27, 2006
• First Posted (Estimate): November 28, 2006

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Asthma; Ciclesonide; Alvesco®
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Ciclesonide
• Other Study ID Numbers: BY9010/CA-102