Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

NCT00163423 | Completed Phase 3

• 1 other identifier: BY9010/M1-142
• Study Type: interventional
• Target: 480
• Locations: 5 countries
• Sites: 51

Brief Summary

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Conditions

Asthma

Keywords

Asthma; Ciclesonide; Fluticasone propionate

Outcome Measures

Primary Outcomes (2)

• FEV1

• time to the first asthma exacerbation.

Secondary Outcomes (13)

• FVC

• asthma symptom score

• use of rescue medication

• AQLQ(S) and EQ-5D

• percentage of days on which patients perceived asthma control

Interventions

Ciclesonide DRUG

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients
• Written informed consent
• History of bronchial asthma for at least 6 months
• Good health with the exception of asthma
• Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
• FEV1 80 - 105% of predicted

You may not qualify if:

• Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
• COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
• Current smoking with more than 10 pack-years
• Previous smoking with more than 10 pack-years
• Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
• Pregnancy
• Intention to become pregnant during the course of the study
• Breast feeding
• Lack of safe contraception

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (51)

Altana Pharma/Nycomed

Gmünd, 3950, Austria

Location

Altana Pharma/Nycomed

Linz, 4020, Austria

Location

Altana Pharma/Nycomed

Linz, 4040, Austria

Location

Altana Pharma/Nycomed

Neusiedl/See, 7100, Austria

Location

Altana Pharma/Nycomed

Perg, 4320, Austria

Location

Altana Pharma/Nycomed

Steyr, 4400, Austria

Location

Altana Pharma/Nycomed

Wiener Neustadt, 2700, Austria

Location

Altana Pharma/Nycomed

Brandon, R7A 5E7, Canada

Location

Altana Pharma/Nycomed

Hamilton, L8N 3Z5, Canada

Location

Altana Pharma/Nycomed

London, N5W 6A2, Canada

Location

Altana Pharma/Nycomed

London, N6C 4Y7, Canada

Location

Altana Pharma/Nycomed

Mississauga, L5B 1N1, Canada

Location

Altana Pharma/Nycomed

Montreal, H2L 4M1, Canada

Location

Altana Pharma/Nycomed

Montreal, H4J1C5, Canada

Location

Altana Pharma/Nycomed

Montreal, Quebec, H1V 1X5, Canada

Location

Altana Pharma/Nycomed

Ottawa, K1Y 4G2, Canada

Location

Altana Pharma/Nycomed

Québec, G8T 7A1, Canada

Location

Altana Pharma/Nycomed

Sainte-Foy, Quebec, G1V4G5, Canada

Location

Altana Pharma/Nycomed

Sarnia, N7T 4X3, Canada

Location

Altana Pharma/Nycomed

Ste-Foy PQ, G1V 4M6, Canada

Location

Altana Pharma/Nycomed

Toronto, M4P1P2, Canada

Location

Altana Pharma/Nycomed

Woodstock, N4S 4G3, Canada

Location

Altana Pharma/Nycomed

Geesthacht, 21502, Germany

Location

Altana Pharma/Nycomed

Hanover, 30167, Germany

Location

Altana Pharma/Nycomed

Heidelberg, 69117, Germany

Location

Altana Pharma/Nycomed

Koblenz, 56068, Germany

Location

Altana Pharma/Nycomed

Mainz, 55131, Germany

Location

Altana Pharma/Nycomed

Marburg, 35037, Germany

Location

Altana Pharma/Nycomed

Sinsheim, 74889, Germany

Location

Altana Pharma/Nycomed

Witten, 58452, Germany

Location

Altana Pharma/Nycomed

Bielsko-Biala, 43316, Poland

Location

Altana Pharma/Nycomed

Gdansk, 80-847, Poland

Location

Altana Pharma/Nycomed

Lodz, 90-141, Poland

Location

Altana Pharma/Nycomed

Lubin, 59300, Poland

Location

Altana Pharma/Nycomed

Lublin, 20-718, Poland

Location

Altana Pharma/Nycomed

Lublin, 20601, Poland

Location

Altana Pharma/Nycomed

Wałbrzych, 58300, Poland

Location

Altana Pharma/Nycomed

Zgierz, 95100, Poland

Location

Altana Pharma/Nycomed

Arcadia, Pretoria, 132, South Africa

Location

Altana Pharma/Nycomed

Bellville, Cape Town, 7530, South Africa

Location

Altana Pharma/Nycomed

Cape Town, 7764, South Africa

Location

Altana Pharma/Nycomed

Cape Town, Tygerberg, 7505, South Africa

Location

Altana Pharma/Nycomed

Durbanville / Cape Town, 7550, South Africa

Location

Altana Pharma/Nycomed

Gatesville, Cape Town, 7764, South Africa

Location

Altana Pharma/Nycomed

Lyttleton, 140, South Africa

Location

Altana Pharma/Nycomed

Mowbray, Cape Town, 7925, South Africa

Location

Altana Pharma/Nycomed

Observatory Cape, 7925, South Africa

Location

Altana Pharma/Nycomed

Pretoria, 181, South Africa

Location

Altana Pharma/Nycomed

Pretoria, 2, South Africa

Location

Altana Pharma/Nycomed

Westville, 3630, South Africa

Location

Altana Pharma/Nycomed

Wynberg, 7945, South Africa

Location

Related Links

• BY9010\_M1-142 Synopsis.pdf

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

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: November 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

AU (7); CA (15); ZA (13); PL (8); DE (8)