Clinical trial NCT00163358: Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)
Official title: Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Fluticasone propionate
Salmeterol
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 630
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 fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria: Main Inclusion Criteria:

* Clinical diagnosis of mild persistent asthma
* Pre-treatment with SABAs only
* FEV1 ≥80% predicted
* Good health with the exception of asthma

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
* Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years

Primary outcomes:
measure: time until the first severe asthma exacerbation occurs
measure: number of poorly controlled asthma days.
Secondary outcomes:
measure: percentage of days with asthma control
measure: percentage of days with asthma symptoms
measure: percentage of nocturnal awakenings due to asthma
measure: asthma symptom score
measure: number of inhalations of rescue medication
measure: proportion of patients with severe asthma exacerbations
measure: differences in morning PEF from diary
measure: differences in FEV1 and FVC from spirometry
measure: blood eosinophils
measure: AQLQ(S)
measure: health economic data
measure: vital signs
measure: laboratory work-up
measure: adverse events.
Other outcomes:
Locations:
city: Adelaide South Australia
country: Australia
facility: Altana Pharma/Nycomed
city: Auchenflower
country: Australia
facility: Altana Pharma/Nycomed
city: Bracken Ridge
country: Australia
facility: Altana Pharma/Nycomed
city: Burwood
country: Australia
facility: Altana Pharma/Nycomed
city: Camperdown
country: Australia
facility: Altana Pharma/Nycomed
city: Carina Heights
country: Australia
facility: Altana Pharma/Nycomed
city: Clayton
country: Australia
facility: Altana Pharma/Nycomed
city: Concord
country: Australia
facility: Altana Pharma/Nycomed
city: Geelong
country: Australia
facility: Altana Pharma/Nycomed
city: Inala
country: Australia
facility: Altana Pharma/Nycomed
city: Kippa-ring
country: Australia
facility: Altana Pharma/Nycomed
city: Nedlands
country: Australia
facility: Altana Pharma/Nycomed
city: Rosebud
country: Australia
facility: Altana Pharma/Nycomed
city: South Brisbane
country: Australia
facility: Altana Pharma/Nycomed
city: Toorak Gardens
country: Australia
facility: Altana Pharma/Nycomed
city: Wayville
country: Australia
facility: Altana Pharma/Nycomed
city: Beaconsfield, QC
country: Canada
facility: Altana Pharma/Nycomed
city: Coquitlam, BC
country: Canada
facility: Altana Pharma/Nycomed
city: Coquitlam
country: Canada
facility: Altana Pharma/Nycomed
city: Corner Brook
country: Canada
facility: Altana Pharma/Nycomed
city: Cowansville
country: Canada
facility: Altana Pharma/Nycomed
city: Kingston, Ontario
country: Canada
facility: Altana Pharma/Nycomed
city: Langley BC
country: Canada
facility: Altana Pharma/Nycomed
city: Laval
country: Canada
facility: Altana Pharma/Nycomed
city: Les Saules, QC
country: Canada
facility: Altana Pharma/Nycomed
city: Longueuil, PQ
country: Canada
facility: Altana Pharma/Nycomed
city: Montreal, PQ
country: Canada
facility: Altana Pharma/Nycomed
city: Montreal
country: Canada
facility: Altana Pharma/Nycomed
city: North Bay
country: Canada
facility: Altana Pharma/Nycomed
city: North York
country: Canada
facility: Altana Pharma/Nycomed
city: Ottawa
country: Canada
facility: Altana Pharma/Nycomed
city: Penticton, BC
country: Canada
facility: Altana Pharma/Nycomed
city: Quebec City
country: Canada
facility: Altana Pharma/Nycomed
city: Saint John's
country: Canada
facility: Altana Pharma/Nycomed
city: Saint John
country: Canada
facility: Altana Pharma/Nycomed
city: Sainte-Foy, Quebec
country: Canada
facility: Altana Pharma/Nycomed
city: Saskatoon, SK
country: Canada
facility: Altana Pharma/Nycomed
city: St. John's
country: Canada
facility: Altana Pharma/Nycomed
city: Ste-Foy PQ
country: Canada
facility: Altana Pharma/Nycomed
city: Toronto ON
country: Canada
facility: Altana Pharma/Nycomed
city: Toronto
country: Canada
facility: Altana Pharma/Nycomed
city: Toronto
country: Canada
facility: Altana Pharma/Nycomed
city: Toronto
country: Canada
facility: Altana Pharma/Nycomed
city: Beroun
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Ceska Lipa
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Cvikov
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Havlickuv
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Jihlava
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Jindrichuv Hradec
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Karlovy Vary
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Kladno
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Kutná Hora
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Ostrava-Marián.Hory
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Praha 10
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Praha 2
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Praha 4
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Praha 8
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Praha 9
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Pribram VI
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Príbram VIII
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Rokycany
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Strakonice
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Trutnov
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Usti nad Labem
country: Czech Republic
facility: Altana Pharma/Nycomed
city: Budapest XI
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapet
country: Hungary
facility: Altana Pharma/Nycomed
city: Kecskemet
country: Hungary
facility: Altana Pharma/Nycomed
city: Nyíregyháza
country: Hungary
facility: Altana Pharma/Nycomed
city: Szarvas
country: Hungary
facility: Altana Pharma/Nycomed
city: Tatabanya
country: Hungary
facility: Altana Pharma/Nycomed
city: Bydgoszcz
country: Poland
facility: Altana Pharma/Nycomed
city: Bydgoszcz
country: Poland
facility: Altana Pharma/Nycomed
city: Lodz
country: Poland
facility: Altana Pharma/Nycomed
city: Lódz'
country: Poland
facility: Altana Pharma/Nycomed
city: Rzeszow
country: Poland
facility: Altana Pharma/Nycomed
city: Rzeszow
country: Poland
facility: Altana Pharma/Nycomed
city: Warszawa
country: Poland
facility: Altana Pharma/Nycomed
city: Wroclaw
country: Poland
facility: Altana Pharma/Nycomed
city: Wroclaw
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: Berea, Durban
country: South Africa
facility: Altana Pharma/Nycomed
city: Bloemfontein
country: South Africa
facility: Altana Pharma/Nycomed
city: Bloemfontein
country: South Africa
facility: Altana Pharma/Nycomed
city: Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Centurion, Pretoria
country: South Africa
facility: Altana Pharma/Nycomed
city: Daveyton
country: South Africa
facility: Altana Pharma/Nycomed
city: Durban, Amanzimtoti
country: South Africa
facility: Altana Pharma/Nycomed
city: George
country: South Africa
facility: Altana Pharma/Nycomed
city: Midrand
country: South Africa
facility: Altana Pharma/Nycomed
city: Mowbray, Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Paarl
country: South Africa
facility: Altana Pharma/Nycomed
city: Panorama / RSA-Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Pretoria
country: South Africa
facility: Altana Pharma/Nycomed
city: Alcorcón (Madrid)
country: Spain
facility: Altana Pharma/Nycomed
city: Alicante
country: Spain
facility: Altana Pharma/Nycomed
city: Alicante
country: Spain
facility: Altana Pharma/Nycomed
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: Campdevanol (Girona)
country: Spain
facility: Altana Pharma/Nycomed
city: Elda (Alicante)
country: Spain
facility: Altana Pharma/Nycomed
city: Guadalajara
country: Spain
facility: Altana Pharma/Nycomed
city: Leganes (Madrid)
country: Spain
facility: Altana Pharma/Nycomed
city: Palma de Mallorca
country: Spain
facility: Altana Pharma/Nycomed
city: Peralada (Girona)
country: Spain
facility: Altana Pharma/Nycomed
city: Petrer (Alicante)
country: Spain
facility: Altana Pharma/Nycomed
city: San Vicente del Raspeig (Alicante)
country: Spain
facility: Altana Pharma/Nycomed
city: Santiago de Compostela
country: Spain
facility: Altana Pharma/Nycomed
city: Valencia
country: Spain
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
citation: Postma DS, O'Byrne PM, Pedersen S. Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control. Chest. 2011 Feb;139(2):311-318. doi: 10.1378/chest.09-1735. Epub 2010 Nov 18.