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| Sponsored by: |
ALTANA Pharma |
|---|---|
| Information provided by: | ALTANA Pharma |
| ClinicalTrials.gov Identifier: | NCT00163358 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Ciclesonide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-Term Asthma Control |
| Estimated Enrollment: | 630 |
| Study Start Date: | September 2003 |
Eligibility| Ages Eligible for Study: | 12 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Contacts and Locations
Hide Study Locations| Australia | |
| Altana Pharma/Nycomed | |
| Concord, Australia, 2139 | |
| Altana Pharma/Nycomed | |
| Adelaide South Australia, Australia, 5000 | |
| Altana Pharma/Nycomed | |
| CAMPERDOWN, Australia, NSW 2050 | |
| Altana Pharma/Nycomed | |
| Burwood, Australia, NSW 2134 | |
| Altana Pharma/Nycomed | |
| Bracken Ridge, Australia, QLD 4017 | |
| Altana Pharma/Nycomed | |
| Kippa-ring, Australia, QLD 4021 | |
| Altana Pharma/Nycomed | |
| Clayton, Australia, VIC 3168 | |
| Altana Pharma/Nycomed | |
| Inala, Australia, QLD 4077 | |
| Altana Pharma/Nycomed | |
| South Brisbane, Australia, QLD 4101 | |
| Altana Pharma/Nycomed | |
| Carina Heights, Australia, QLD 4152 | |
| Altana Pharma/Nycomed | |
| Wayville, Australia, SA 5034 | |
| Altana Pharma/Nycomed | |
| Toorak Gardens, Australia, SA 5056 | |
| Altana Pharma/Nycomed | |
| Auchenflower, Australia, QLD 4066 | |
| Altana Pharma/Nycomed | |
| Geelong, Australia, VIC 3220 | |
| Altana Pharma/Nycomed | |
| Rosebud, Australia, VIC 3939 | |
| Altana Pharma/Nycomed | |
| Nedlands, Australia, WA 6009 | |
| Canada | |
| Altana Pharma/Nycomed | |
| Saint John's, Canada, A1A 3R5 | |
| Altana Pharma/Nycomed | |
| St. John's, Canada, A1E 2C2 | |
| Altana Pharma/Nycomed | |
| Saint John, Canada, E2K2T8 | |
| Altana Pharma/Nycomed | |
| Les Saules, QC, Canada, G1P 1J6 | |
| Altana Pharma/Nycomed | |
| Beaconsfield, QC, Canada, H9W2X3 | |
| Altana Pharma/Nycomed | |
| Sainte-Foy, Quebec, Canada, G1V4G5 | |
| Altana Pharma/Nycomed | |
| Quebec City, Canada, G8T 7A1 | |
| Altana Pharma/Nycomed | |
| Montreal, PQ, Canada, H3H 1V4 | |
| Altana Pharma/Nycomed | |
| Montreal, Canada, H4J1C5 | |
| Altana Pharma/Nycomed | |
| Laval, Canada, H7V3Y7 | |
| Altana Pharma/Nycomed | |
| Ste-Foy PQ, Canada, G1V 4M6 | |
| Altana Pharma/Nycomed | |
| Cowansville, Canada, J2K2X9 | |
| Altana Pharma/Nycomed | |
| Longueuil, PQ, Canada, J4N 1E1 | |
| Altana Pharma/Nycomed | |
| Ottawa, Canada, K1Y 4G2 | |
| Altana Pharma/Nycomed | |
| Kingston, Ontario, Canada, K7L 2V6 | |
| Altana Pharma/Nycomed | |
| North York, Canada, M3H 3S3 | |
| Altana Pharma/Nycomed | |
| Toronto, Canada, M4N3N5 | |
| Altana Pharma/Nycomed | |
| Toronto, Canada, M4P1P2 | |
| Altana Pharma/Nycomed | |
| Langley BC, Canada, V3A 4H9 | |
| Altana Pharma/Nycomed | |
| Toronto, Canada, M9W 4L6 | |
| Altana Pharma/Nycomed | |
| Corner Brook, Canada, NFLD | |
| Altana Pharma/Nycomed | |
| North Bay, Canada, P1B2H3 | |
| Altana Pharma/Nycomed | |
| Saskatoon, SK, Canada, S7K 3H3 | |
| Altana Pharma/Nycomed | |
| Penticton, BC, Canada, V2A 5C8 | |
| Altana Pharma/Nycomed | |
| Toronto ON, Canada, M5S 2A5 | |
| Altana Pharma/Nycomed | |
| Coquitlam, Canada, V3K 3P4 | |
| Altana Pharma/Nycomed | |
| Coquitlam, BC, Canada, V3K 3V9 | |
| Czech Republic | |
| Altana Pharma/Nycomed | |
| Praha 10, Czech Republic, 100 00 | |
| Altana Pharma/Nycomed | |
| Praha 2, Czech Republic, 128 00 | |
| Altana Pharma/Nycomed | |
| Praha 4, Czech Republic, 14046 | |
| Altana Pharma/Nycomed | |
| Praha 8, Czech Republic, 181 00 | |
| Altana Pharma/Nycomed | |
| Praha 9, Czech Republic, 190 61 | |
| Altana Pharma/Nycomed | |
| Karlovy Vary, Czech Republic, 360 00 | |
| Altana Pharma/Nycomed | |
| Pribram VI, Czech Republic, 261 05 | |
| Altana Pharma/Nycomed | |
| Beroun, Czech Republic, 266 01 | |
| Altana Pharma/Nycomed | |
| Kladno, Czech Republic, 272 01 | |
| Altana Pharma/Nycomed | |
| Kutná Hora, Czech Republic, 28401 | |
| Altana Pharma/Nycomed | |
| Rokycany, Czech Republic, 337 01 | |
| Altana Pharma/Nycomed | |
| Príbram VIII, Czech Republic, 261 01 | |
| Altana Pharma/Nycomed | |
| Jindrichuv Hradec, Czech Republic, 377 01 | |
| Altana Pharma/Nycomed | |
| Strakonice, Czech Republic, 38601 | |
| Altana Pharma/Nycomed | |
| Usti nad Labem, Czech Republic, 401 13 | |
| Altana Pharma/Nycomed | |
| Ceska Lipa, Czech Republic, 470 01 | |
| Altana Pharma/Nycomed | |
| Havlickuv, Czech Republic, 580 01 | |
| Altana Pharma/Nycomed | |
| Trutnov, Czech Republic, 54101 | |
| Altana Pharma/Nycomed | |
| Cvikov, Czech Republic, 471 54 | |
| Altana Pharma/Nycomed | |
| Jihlava, Czech Republic, 58601 | |
| Altana Pharma/Nycomed | |
| Ostrava-Marián.Hory, Czech Republic, 70030 | |
| Hungary | |
| Altana Pharma/Nycomed | |
| Budapest, Hungary, 1046 | |
| Altana Pharma/Nycomed | |
| Budapest XI, Hungary, 1117 | |
| Altana Pharma/Nycomed | |
| Budapet, Hungary, 1529 | |
| Altana Pharma/Nycomed | |
| Budapest, Hungary, 1529 | |
| Altana Pharma/Nycomed | |
| Budapest, Hungary, 1134 | |
| Altana Pharma/Nycomed | |
| Tatabanya, Hungary, 2800 | |
| Altana Pharma/Nycomed | |
| Nyíregyháza, Hungary, 4400 | |
| Altana Pharma/Nycomed | |
| Szarvas, Hungary, 5540 | |
| Altana Pharma/Nycomed | |
| Kecskemet, Hungary, 6000 | |
| Poland | |
| Altana Pharma/Nycomed | |
| Rzeszow, Poland, 35-302 | |
| Altana Pharma/Nycomed | |
| Rzeszow, Poland, 35-068 | |
| Altana Pharma/Nycomed | |
| Warszawa, Poland, 01-138 | |
| Altana Pharma/Nycomed | |
| Wroclaw, Poland, 50-417 | |
| Altana Pharma/Nycomed | |
| Wroclaw, Poland, 53-674 | |
| Altana Pharma/Nycomed | |
| Bydgoszcz, Poland, 85-091 | |
| Altana Pharma/Nycomed | |
| Bydgoszcz, Poland, 85-681 | |
| Altana Pharma/Nycomed | |
| Lódz', Poland, 90-153 | |
| Altana Pharma/Nycomed | |
| Lodz, Poland, 91-520 | |
| South Africa | |
| Altana Pharma/Nycomed | |
| Arcadia, Pretoria, South Africa, 132 | |
| Altana Pharma/Nycomed | |
| Daveyton, South Africa, 1520 | |
| Altana Pharma/Nycomed | |
| Centurion, Pretoria, South Africa, 157 | |
| Altana Pharma/Nycomed | |
| Midrand, South Africa, 1685 | |
| Altana Pharma/Nycomed | |
| Pretoria, South Africa, 186 | |
| Altana Pharma/Nycomed | |
| Berea, Durban, South Africa, 4000 | |
| Altana Pharma/Nycomed | |
| Durban, Amanzimtoti, South Africa, 4126 | |
| Altana Pharma/Nycomed | |
| George, South Africa, 6539 | |
| Altana Pharma/Nycomed | |
| Bloemfontein, South Africa, 9301 | |
| Altana Pharma/Nycomed | |
| Bellville, Cape Town, South Africa, 7530 | |
| Altana Pharma/Nycomed | |
| Paarl, South Africa, 7646 | |
| Altana Pharma/Nycomed | |
| Cape Town, South Africa, 7764 | |
| Altana Pharma/Nycomed | |
| Mowbray, Cape Town, South Africa, 7925 | |
| Altana Pharma/Nycomed | |
| Bloemfontein, South Africa, 9300 | |
| Altana Pharma/Nycomed | |
| Panorama / RSA-Cape Town, South Africa, 7500 | |
| Spain | |
| Altana Pharma/Nycomed | |
| Barcelona, Spain, 8222 | |
| Altana Pharma/Nycomed | |
| Peralada (Girona), Spain, 17491 | |
| Altana Pharma/Nycomed | |
| Campdevanol (Girona), Spain, 17530 | |
| Altana Pharma/Nycomed | |
| Guadalajara, Spain, 19002 | |
| Altana Pharma/Nycomed | |
| Leganes (Madrid), Spain, 28914 | |
| Altana Pharma/Nycomed | |
| Alcorcón (Madrid), Spain, 28922 | |
| Altana Pharma/Nycomed | |
| Alicante, Spain, 3001 | |
| Altana Pharma/Nycomed | |
| San Vicente del Raspeig (Alicante), Spain, 3187 | |
| Altana Pharma/Nycomed | |
| Alicante, Spain, 3540 | |
| Altana Pharma/Nycomed | |
| Elda (Alicante), Spain, 3600 | |
| Altana Pharma/Nycomed | |
| Petrer (Alicante), Spain, 3610 | |
| Altana Pharma/Nycomed | |
| Valencia, Spain, 46017 | |
| Altana Pharma/Nycomed | |
| Palma de Mallorca, Spain, 7014 | |
| Altana Pharma/Nycomed | |
| Santiago de Compostela, Spain, 15706 | |
| Study Chair: | Paul O'Byrne, Prof. | McMaster University in Hamilton, Ontario, Canada |
| Study Chair: | Søren Pedersen, Prof. | University of Odense, Kolding, Denmark |
| Study Chair: | D.S. Postma, Prof. | University Hospital of Groningen, The Netherlands |
More Information
| Study ID Numbers: | BY9010/M1-132 |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00163358 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Asthma Ciclesonide Fluticasone propionate Salmeterol |
|
Anti-Inflammatory Agents Neurotransmitter Agents Salmeterol Bronchial Diseases Adrenergic Agents Adrenergic beta-Agonists Ciclesonide Anti-Asthmatic Agents Asthma Anti-Allergic Agents |
Adrenergic Agonists Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
|
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Ciclesonide Physiological Effects of Drugs Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Fluticasone |
Dermatologic Agents Salmeterol Adrenergic beta-Agonists Immune System Diseases Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
