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)
NCT ID: NCT00163358
Last Updated: 2016-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
630 participants
INTERVENTIONAL
2003-09-30
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Ciclesonide
Eligibility Criteria
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Inclusion Criteria
* Pre-treatment with SABAs only
* FEV1 ≥80% predicted
* Good health with the exception of asthma
Exclusion Criteria
* 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
12 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Altana Pharma/Nycomed
Adelaide South Australia, , Australia
Altana Pharma/Nycomed
Auchenflower, , Australia
Altana Pharma/Nycomed
Bracken Ridge, , Australia
Altana Pharma/Nycomed
Burwood, , Australia
Altana Pharma/Nycomed
Camperdown, , Australia
Altana Pharma/Nycomed
Carina Heights, , Australia
Altana Pharma/Nycomed
Clayton, , Australia
Altana Pharma/Nycomed
Concord, , Australia
Altana Pharma/Nycomed
Geelong, , Australia
Altana Pharma/Nycomed
Inala, , Australia
Altana Pharma/Nycomed
Kippa-Ring, , Australia
Altana Pharma/Nycomed
Nedlands, , Australia
Altana Pharma/Nycomed
Rosebud, , Australia
Altana Pharma/Nycomed
South Brisbane, , Australia
Altana Pharma/Nycomed
Toorak Gardens, , Australia
Altana Pharma/Nycomed
Wayville, , Australia
Altana Pharma/Nycomed
Beaconsfield, QC, , Canada
Altana Pharma/Nycomed
Coquitlam, , Canada
Altana Pharma/Nycomed
Coquitlam, BC, , Canada
Altana Pharma/Nycomed
Corner Brook, , Canada
Altana Pharma/Nycomed
Cowansville, , Canada
Altana Pharma/Nycomed
Kingston, Ontario, , Canada
Altana Pharma/Nycomed
Langley BC, , Canada
Altana Pharma/Nycomed
Laval, , Canada
Altana Pharma/Nycomed
Les Saules, QC, , Canada
Altana Pharma/Nycomed
Longueuil, PQ, , Canada
Altana Pharma/Nycomed
Montreal, , Canada
Altana Pharma/Nycomed
Montreal, PQ, , Canada
Altana Pharma/Nycomed
North Bay, , Canada
Altana Pharma/Nycomed
North York, , Canada
Altana Pharma/Nycomed
Ottawa, , Canada
Altana Pharma/Nycomed
Penticton, BC, , Canada
Altana Pharma/Nycomed
Québec, , Canada
Altana Pharma/Nycomed
Saint John, , Canada
Altana Pharma/Nycomed
Sainte-Foy, Quebec, , Canada
Altana Pharma/Nycomed
Saskatoon, SK, , Canada
Altana Pharma/Nycomed
St. John's, , Canada
Altana Pharma/Nycomed
St. John's, , Canada
Altana Pharma/Nycomed
Ste-Foy PQ, , Canada
Altana Pharma/Nycomed
Toronto, , Canada
Altana Pharma/Nycomed
Toronto, , Canada
Altana Pharma/Nycomed
Toronto, , Canada
Altana Pharma/Nycomed
Toronto on, , Canada
Altana Pharma/Nycomed
Beroun, , Czechia
Altana Pharma/Nycomed
Cvikov, , Czechia
Altana Pharma/Nycomed
Česká Lípa, , Czechia
Altana Pharma/Nycomed
Havlickuv, , Czechia
Altana Pharma/Nycomed
Jihlava, , Czechia
Altana Pharma/Nycomed
Jindřichův Hradec, , Czechia
Altana Pharma/Nycomed
Karlovy Vary, , Czechia
Altana Pharma/Nycomed
Kladno, , Czechia
Altana Pharma/Nycomed
Kutná Hora, , Czechia
Altana Pharma/Nycomed
Ostrava-Marián.Hory, , Czechia
Altana Pharma/Nycomed
Prague, , Czechia
Altana Pharma/Nycomed
Prague, , Czechia
Altana Pharma/Nycomed
Prague, , Czechia
Altana Pharma/Nycomed
Prague, , Czechia
Altana Pharma/Nycomed
Prague, , Czechia
Altana Pharma/Nycomed
Pribram VI, , Czechia
Altana Pharma/Nycomed
Príbram VIII, , Czechia
Altana Pharma/Nycomed
Rokycany, , Czechia
Altana Pharma/Nycomed
Strakonice, , Czechia
Altana Pharma/Nycomed
Trutnov, , Czechia
Altana Pharma/Nycomed
Ústí nad Labem, , Czechia
Altana Pharma/Nycomed
Budapest, , Hungary
Altana Pharma/Nycomed
Budapest, , Hungary
Altana Pharma/Nycomed
Budapest, , Hungary
Altana Pharma/Nycomed
Budapest XI, , Hungary
Altana Pharma/Nycomed
Budapet, , Hungary
Altana Pharma/Nycomed
Kecskemét, , Hungary
Altana Pharma/Nycomed
Nyíregyháza, , Hungary
Altana Pharma/Nycomed
Szarvas, , Hungary
Altana Pharma/Nycomed
Tatabánya, , Hungary
Altana Pharma/Nycomed
Bydgoszcz, , Poland
Altana Pharma/Nycomed
Bydgoszcz, , Poland
Altana Pharma/Nycomed
Lodz, , Poland
Altana Pharma/Nycomed
Lódz', , Poland
Altana Pharma/Nycomed
Rzeszów, , Poland
Altana Pharma/Nycomed
Rzeszów, , Poland
Altana Pharma/Nycomed
Warsaw, , Poland
Altana Pharma/Nycomed
Wroclaw, , Poland
Altana Pharma/Nycomed
Wroclaw, , Poland
Altana Pharma/Nycomed
Arcadia, Pretoria, , South Africa
Altana Pharma/Nycomed
Bellville, Cape Town, , South Africa
Altana Pharma/Nycomed
Berea, Durban, , South Africa
Altana Pharma/Nycomed
Bloemfontein, , South Africa
Altana Pharma/Nycomed
Bloemfontein, , South Africa
Altana Pharma/Nycomed
Cape Town, , South Africa
Altana Pharma/Nycomed
Centurion, Pretoria, , South Africa
Altana Pharma/Nycomed
Daveyton, , South Africa
Altana Pharma/Nycomed
Durban, Amanzimtoti, , South Africa
Altana Pharma/Nycomed
George, , South Africa
Altana Pharma/Nycomed
Midrand, , South Africa
Altana Pharma/Nycomed
Mowbray, Cape Town, , South Africa
Altana Pharma/Nycomed
Paarl, , South Africa
Altana Pharma/Nycomed
Panorama / RSA-Cape Town, , South Africa
Altana Pharma/Nycomed
Pretoria, , South Africa
Altana Pharma/Nycomed
Alcorcón (Madrid), , Spain
Altana Pharma/Nycomed
Alicante, , Spain
Altana Pharma/Nycomed
Alicante, , Spain
Altana Pharma/Nycomed
Barcelona, , Spain
Altana Pharma/Nycomed
Campdevanol (Girona), , Spain
Altana Pharma/Nycomed
Elda (Alicante), , Spain
Altana Pharma/Nycomed
Guadalajara, , Spain
Altana Pharma/Nycomed
Leganes (Madrid), , Spain
Altana Pharma/Nycomed
Palma de Mallorca, , Spain
Altana Pharma/Nycomed
Peralada (Girona), , Spain
Altana Pharma/Nycomed
Petrer (Alicante), , Spain
Altana Pharma/Nycomed
San Vicente Del Raspeig (Alicante), , Spain
Altana Pharma/Nycomed
Santiago de Compostela, , Spain
Altana Pharma/Nycomed
Valencia, , Spain
Countries
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References
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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.
Related Links
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BY9010-MI-132-RDS-2007-02-12.pdf
Other Identifiers
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BY9010/M1-132
Identifier Type: -
Identifier Source: org_study_id