Clinical trial NCT00163423: Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Fluticasone propionate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 480
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: FEV1
measure: time to the first asthma exacerbation.
Secondary outcomes:
measure: FVC
measure: asthma symptom score
measure: use of rescue medication
measure: AQLQ(S) and EQ-5D
measure: percentage of days on which patients perceived asthma control
measure: percentage of nocturnal awakening-free days
measure: percentage of rescue medication-free days
measure: percentage of asthma symptom-free days
measure: physical examination
measure: vital signs
measure: standard laboratory work-up
measure: adverse events
measure: number of patients with local oropharyngeal adverse events.
Other outcomes:
Locations:
city: Gmünd
country: Austria
facility: Altana Pharma/Nycomed
city: Linz
country: Austria
facility: Altana Pharma/Nycomed
city: Linz
country: Austria
facility: Altana Pharma/Nycomed
city: Neusiedl/See
country: Austria
facility: Altana Pharma/Nycomed
city: Perg
country: Austria
facility: Altana Pharma/Nycomed
city: Steyr
country: Austria
facility: Altana Pharma/Nycomed
city: Wiener Neustadt
country: Austria
facility: Altana Pharma/Nycomed
city: Brandon
country: Canada
facility: Altana Pharma/Nycomed
city: Hamilton
country: Canada
facility: Altana Pharma/Nycomed
city: London
country: Canada
facility: Altana Pharma/Nycomed
city: London
country: Canada
facility: Altana Pharma/Nycomed
city: Mississauga
country: Canada
facility: Altana Pharma/Nycomed
city: Montreal, Quebec
country: Canada
facility: Altana Pharma/Nycomed
city: Montreal
country: Canada
facility: Altana Pharma/Nycomed
city: Montreal
country: Canada
facility: Altana Pharma/Nycomed
city: Ottawa
country: Canada
facility: Altana Pharma/Nycomed
city: Quebec City
country: Canada
facility: Altana Pharma/Nycomed
city: Sainte-Foy, Quebec
country: Canada
facility: Altana Pharma/Nycomed
city: Sarnia
country: Canada
facility: Altana Pharma/Nycomed
city: Ste-Foy PQ
country: Canada
facility: Altana Pharma/Nycomed
city: Toronto
country: Canada
facility: Altana Pharma/Nycomed
city: Woodstock
country: Canada
facility: Altana Pharma/Nycomed
city: Geesthacht
country: Germany
facility: Altana Pharma/Nycomed
city: Hannover
country: Germany
facility: Altana Pharma/Nycomed
city: Heidelberg
country: Germany
facility: Altana Pharma/Nycomed
city: Koblenz
country: Germany
facility: Altana Pharma/Nycomed
city: Mainz
country: Germany
facility: Altana Pharma/Nycomed
city: Marburg
country: Germany
facility: Altana Pharma/Nycomed
city: Sinsheim
country: Germany
facility: Altana Pharma/Nycomed
city: Witten
country: Germany
facility: Altana Pharma/Nycomed
city: Bielsko-Biala
country: Poland
facility: Altana Pharma/Nycomed
city: Gdansk
country: Poland
facility: Altana Pharma/Nycomed
city: Lodz
country: Poland
facility: Altana Pharma/Nycomed
city: Lubin
country: Poland
facility: Altana Pharma/Nycomed
city: Lublin
country: Poland
facility: Altana Pharma/Nycomed
city: Lublin
country: Poland
facility: Altana Pharma/Nycomed
city: Walbrzych
country: Poland
facility: Altana Pharma/Nycomed
city: Zgierz
country: Poland
facility: Altana Pharma/Nycomed
city: Arcadia, Pretoria
country: South Africa
facility: Altana Pharma/Nycomed
city: Bellville, Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Cape Town, Tygerberg
country: South Africa
facility: Altana Pharma/Nycomed
city: Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Durbanville / Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Gatesville, Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Lyttleton
country: South Africa
facility: Altana Pharma/Nycomed
city: Mowbray, Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Observatory Cape
country: South Africa
facility: Altana Pharma/Nycomed
city: Pretoria
country: South Africa
facility: Altana Pharma/Nycomed
city: Pretoria
country: South Africa
facility: Altana Pharma/Nycomed
city: Westville
country: South Africa
facility: Altana Pharma/Nycomed
city: Wynberg
country: South Africa
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: