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)

NCT00163358 | Completed Phase 3

• 1 other identifier: BY9010/M1-132
• Study Type: interventional
• Target: 630
• Locations: 7 countries
• Sites: 111

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.

Conditions

Asthma

Keywords

Asthma; Ciclesonide; Fluticasone propionate; Salmeterol

Outcome Measures

Primary Outcomes (2)

• time until the first severe asthma exacerbation occurs

• number of poorly controlled asthma days.

Secondary Outcomes (14)

• percentage of days with asthma control

• percentage of days with asthma symptoms

• percentage of nocturnal awakenings due to asthma

• asthma symptom score

• number of inhalations of rescue medication

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:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (111)

Altana Pharma/Nycomed

Adelaide South Australia, 5000, Australia

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Auchenflower, QLD 4066, Australia

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Bracken Ridge, QLD 4017, Australia

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Burwood, NSW 2134, Australia

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Camperdown, NSW 2050, Australia

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Carina Heights, QLD 4152, Australia

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Clayton, VIC 3168, Australia

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Concord, 2139, Australia

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Geelong, VIC 3220, Australia

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Altana Pharma/Nycomed

Inala, QLD 4077, Australia

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Altana Pharma/Nycomed

Kippa-Ring, QLD 4021, Australia

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Altana Pharma/Nycomed

Nedlands, WA 6009, Australia

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Altana Pharma/Nycomed

Rosebud, VIC 3939, Australia

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Altana Pharma/Nycomed

South Brisbane, QLD 4101, Australia

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Toorak Gardens, SA 5056, Australia

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Altana Pharma/Nycomed

Wayville, SA 5034, Australia

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Altana Pharma/Nycomed

Beaconsfield, QC, H9W2X3, Canada

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Coquitlam, V3K 3P4, Canada

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Coquitlam, BC, V3K 3V9, Canada

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Corner Brook, NFLD, Canada

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Cowansville, J2K2X9, Canada

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Kingston, Ontario, K7L 2V6, Canada

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Langley BC, V3A 4H9, Canada

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Laval, H7V3Y7, Canada

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Les Saules, QC, G1P 1J6, Canada

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Longueuil, PQ, J4N 1E1, Canada

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Montreal, H4J1C5, Canada

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Montreal, PQ, H3H 1V4, Canada

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North Bay, P1B2H3, Canada

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North York, M3H 3S3, Canada

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Ottawa, K1Y 4G2, Canada

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Penticton, BC, V2A 5C8, Canada

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Québec, G8T 7A1, Canada

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Saint John, E2K2T8, Canada

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Sainte-Foy, Quebec, G1V4G5, Canada

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Saskatoon, SK, S7K 3H3, Canada

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St. John's, A1A 3R5, Canada

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St. John's, A1E 2C2, Canada

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Ste-Foy PQ, G1V 4M6, Canada

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Toronto, M4N3N5, Canada

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Toronto, M4P1P2, Canada

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Toronto, M9W 4L6, Canada

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Toronto on, M5S 2A5, Canada

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Altana Pharma/Nycomed

Beroun, 266 01, Czechia

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Cvikov, 471 54, Czechia

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Česká Lípa, 470 01, Czechia

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Havlickuv, 580 01, Czechia

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Jihlava, 58601, Czechia

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Jindřichův Hradec, 377 01, Czechia

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Karlovy Vary, 360 00, Czechia

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Altana Pharma/Nycomed

Kladno, 272 01, Czechia

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Altana Pharma/Nycomed

Kutná Hora, 28401, Czechia

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Altana Pharma/Nycomed

Ostrava-Marián.Hory, 70030, Czechia

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Altana Pharma/Nycomed

Prague, 100 00, Czechia

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Prague, 128 00, Czechia

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Altana Pharma/Nycomed

Prague, 14046, Czechia

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Prague, 181 00, Czechia

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Prague, 190 61, Czechia

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Pribram VI, 261 05, Czechia

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Príbram VIII, 261 01, Czechia

Location

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Rokycany, 337 01, Czechia

Location

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Strakonice, 38601, Czechia

Location

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Trutnov, 54101, Czechia

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Altana Pharma/Nycomed

Ústí nad Labem, 401 13, Czechia

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Altana Pharma/Nycomed

Budapest, 1046, Hungary

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Altana Pharma/Nycomed

Budapest, 1134, Hungary

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Budapest, 1529, Hungary

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Altana Pharma/Nycomed

Budapest XI, 1117, Hungary

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Budapet, 1529, Hungary

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Kecskemét, 6000, Hungary

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Nyíregyháza, 4400, Hungary

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Szarvas, 5540, Hungary

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Tatabánya, 2800, Hungary

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Bydgoszcz, 85-091, Poland

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Bydgoszcz, 85-681, Poland

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Lodz, 91-520, Poland

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Lódz', 90-153, Poland

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Rzeszów, 35-068, Poland

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Rzeszów, 35-302, Poland

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Warsaw, 01-138, Poland

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Wroclaw, 50-417, Poland

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Altana Pharma/Nycomed

Wroclaw, 53-674, Poland

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Altana Pharma/Nycomed

Arcadia, Pretoria, 132, South Africa

Location

Altana Pharma/Nycomed

Bellville, Cape Town, 7530, South Africa

Location

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Berea, Durban, 4000, South Africa

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Bloemfontein, 9300, South Africa

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Bloemfontein, 9301, South Africa

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Cape Town, 7764, South Africa

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Centurion, Pretoria, 157, South Africa

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Daveyton, 1520, South Africa

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Durban, Amanzimtoti, 4126, South Africa

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George, 6539, South Africa

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Midrand, 1685, South Africa

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Mowbray, Cape Town, 7925, South Africa

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Paarl, 7646, South Africa

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Panorama / RSA-Cape Town, 7500, South Africa

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Pretoria, 186, South Africa

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Altana Pharma/Nycomed

Alcorcón (Madrid), 28922, Spain

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Alicante, 3001, Spain

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Alicante, 3540, Spain

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Barcelona, 8222, Spain

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Campdevanol (Girona), 17530, Spain

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Elda (Alicante), 3600, Spain

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Guadalajara, 19002, Spain

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Leganes (Madrid), 28914, Spain

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Palma de Mallorca, 7014, Spain

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Peralada (Girona), 17491, Spain

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Petrer (Alicante), 3610, Spain

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Altana Pharma/Nycomed

San Vicente Del Raspeig (Alicante), 3187, Spain

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Altana Pharma/Nycomed

Santiago de Compostela, 15706, Spain

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Altana Pharma/Nycomed

Valencia, 46017, Spain

Location

Related Publications (1)

• 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.

  PMID: 21088114 DERIVED

Related Links

• BY9010-MI-132-RDS-2007-02-12.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: September 1, 2003
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: November 30, 2016

Record last verified: 2016-10

Locations

HU (9); ES (14); CA (27); ZA (15); CZ (21); AU (16); PL (9)