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

Asthma Clinical Trial

Official title:

Comparison of Ciclesonide (80 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily) in Patients With Mild to Moderate Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163423
• Other study ID #: BY9010/M1-142
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: December 7, 2016
• Start date: November 2004
• Est. completion date: January 2006

Study information

• Verified date: December 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

Main Inclusion Criteria:

• 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

Main Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide

Locations

Country	Name	City	State
Austria	Altana Pharma/Nycomed	Gmünd
Austria	Altana Pharma/Nycomed	Linz
Austria	Altana Pharma/Nycomed	Linz
Austria	Altana Pharma/Nycomed	Neusiedl/See
Austria	Altana Pharma/Nycomed	Perg
Austria	Altana Pharma/Nycomed	Steyr
Austria	Altana Pharma/Nycomed	Wiener Neustadt
Canada	Altana Pharma/Nycomed	Brandon
Canada	Altana Pharma/Nycomed	Hamilton
Canada	Altana Pharma/Nycomed	London
Canada	Altana Pharma/Nycomed	London
Canada	Altana Pharma/Nycomed	Mississauga
Canada	Altana Pharma/Nycomed	Montreal
Canada	Altana Pharma/Nycomed	Montreal
Canada	Altana Pharma/Nycomed	Montreal, Quebec
Canada	Altana Pharma/Nycomed	Ottawa
Canada	Altana Pharma/Nycomed	Quebec City
Canada	Altana Pharma/Nycomed	Sainte-Foy, Quebec
Canada	Altana Pharma/Nycomed	Sarnia
Canada	Altana Pharma/Nycomed	Ste-Foy PQ
Canada	Altana Pharma/Nycomed	Toronto
Canada	Altana Pharma/Nycomed	Woodstock
Germany	Altana Pharma/Nycomed	Geesthacht
Germany	Altana Pharma/Nycomed	Hannover
Germany	Altana Pharma/Nycomed	Heidelberg
Germany	Altana Pharma/Nycomed	Koblenz
Germany	Altana Pharma/Nycomed	Mainz
Germany	Altana Pharma/Nycomed	Marburg
Germany	Altana Pharma/Nycomed	Sinsheim
Germany	Altana Pharma/Nycomed	Witten
Poland	Altana Pharma/Nycomed	Bielsko-Biala
Poland	Altana Pharma/Nycomed	Gdansk
Poland	Altana Pharma/Nycomed	Lodz
Poland	Altana Pharma/Nycomed	Lubin
Poland	Altana Pharma/Nycomed	Lublin
Poland	Altana Pharma/Nycomed	Lublin
Poland	Altana Pharma/Nycomed	Walbrzych
Poland	Altana Pharma/Nycomed	Zgierz
South Africa	Altana Pharma/Nycomed	Arcadia, Pretoria
South Africa	Altana Pharma/Nycomed	Bellville, Cape Town
South Africa	Altana Pharma/Nycomed	Cape Town
South Africa	Altana Pharma/Nycomed	Cape Town, Tygerberg
South Africa	Altana Pharma/Nycomed	Durbanville / Cape Town
South Africa	Altana Pharma/Nycomed	Gatesville, Cape Town
South Africa	Altana Pharma/Nycomed	Lyttleton
South Africa	Altana Pharma/Nycomed	Mowbray, Cape Town
South Africa	Altana Pharma/Nycomed	Observatory Cape
South Africa	Altana Pharma/Nycomed	Pretoria
South Africa	Altana Pharma/Nycomed	Pretoria
South Africa	Altana Pharma/Nycomed	Westville
South Africa	Altana Pharma/Nycomed	Wynberg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Canada,  Germany,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1
Primary	time to the first asthma exacerbation.
Secondary	FVC
Secondary	asthma symptom score
Secondary	use of rescue medication
Secondary	AQLQ(S) and EQ-5D
Secondary	percentage of days on which patients perceived asthma control
Secondary	percentage of nocturnal awakening-free days
Secondary	percentage of rescue medication-free days
Secondary	percentage of asthma symptom-free days
Secondary	physical examination
Secondary	vital signs
Secondary	standard laboratory work-up
Secondary	adverse events
Secondary	number of patients with local oropharyngeal adverse events.

External Links

•   BY9010_M1-142 Synopsis.pdf