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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| time until the first severe asthma exacerbation occurs | ||
| number of poorly controlled asthma days. |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of days with asthma control | ||
| percentage of days with asthma symptoms | ||
| percentage of nocturnal awakenings due to asthma |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altana Pharma/Nycomed | Adelaide South Australia | 5000 | Australia | |||
| Altana Pharma/Nycomed |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21088114 | Derived | 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. |
| Label | URL |
|---|---|
| BY9010-MI-132-RDS-2007-02-12.pdf | View source |
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| asthma symptom score |
| number of inhalations of rescue medication |
| proportion of patients with severe asthma exacerbations |
| differences in morning PEF from diary |
| differences in FEV1 and FVC from spirometry |
| blood eosinophils |
| AQLQ(S) |
| health economic data |
| vital signs |
| laboratory work-up |
| adverse events. |
| Auchenflower |
| QLD 4066 |
| Australia |
| Altana Pharma/Nycomed | Bracken Ridge | QLD 4017 | Australia |
| Altana Pharma/Nycomed | Burwood | NSW 2134 | Australia |
| Altana Pharma/Nycomed | Camperdown | NSW 2050 | Australia |
| Altana Pharma/Nycomed | Carina Heights | QLD 4152 | Australia |
| Altana Pharma/Nycomed | Clayton | VIC 3168 | Australia |
| Altana Pharma/Nycomed | Concord | 2139 | Australia |
| Altana Pharma/Nycomed | Geelong | VIC 3220 | Australia |
| Altana Pharma/Nycomed | Inala | QLD 4077 | Australia |
| Altana Pharma/Nycomed | Kippa-Ring | QLD 4021 | Australia |
| Altana Pharma/Nycomed | Nedlands | WA 6009 | Australia |
| Altana Pharma/Nycomed | Rosebud | VIC 3939 | Australia |
| Altana Pharma/Nycomed | South Brisbane | QLD 4101 | Australia |
| Altana Pharma/Nycomed | Toorak Gardens | SA 5056 | Australia |
| Altana Pharma/Nycomed | Wayville | SA 5034 | Australia |
| Altana Pharma/Nycomed | Beaconsfield, QC | H9W2X3 | Canada |
| Altana Pharma/Nycomed | Coquitlam | V3K 3P4 | Canada |
| Altana Pharma/Nycomed | Coquitlam, BC | V3K 3V9 | Canada |
| Altana Pharma/Nycomed | Corner Brook | NFLD | Canada |
| Altana Pharma/Nycomed | Cowansville | J2K2X9 | Canada |
| Altana Pharma/Nycomed | Kingston, Ontario | K7L 2V6 | Canada |
| Altana Pharma/Nycomed | Langley BC | V3A 4H9 | Canada |
| Altana Pharma/Nycomed | Laval | H7V3Y7 | Canada |
| Altana Pharma/Nycomed | Les Saules, QC | G1P 1J6 | Canada |
| Altana Pharma/Nycomed | Longueuil, PQ | J4N 1E1 | Canada |
| Altana Pharma/Nycomed | Montreal | H4J1C5 | Canada |
| Altana Pharma/Nycomed | Montreal, PQ | H3H 1V4 | Canada |
| Altana Pharma/Nycomed | North Bay | P1B2H3 | Canada |
| Altana Pharma/Nycomed | North York | M3H 3S3 | Canada |
| Altana Pharma/Nycomed | Ottawa | K1Y 4G2 | Canada |
| Altana Pharma/Nycomed | Penticton, BC | V2A 5C8 | Canada |
| Altana Pharma/Nycomed | Québec | G8T 7A1 | Canada |
| Altana Pharma/Nycomed | Saint John | E2K2T8 | Canada |
| Altana Pharma/Nycomed | Sainte-Foy, Quebec | G1V4G5 | Canada |
| Altana Pharma/Nycomed | Saskatoon, SK | S7K 3H3 | Canada |
| Altana Pharma/Nycomed | St. John's | A1A 3R5 | Canada |
| Altana Pharma/Nycomed | St. John's | A1E 2C2 | Canada |
| Altana Pharma/Nycomed | Ste-Foy PQ | G1V 4M6 | Canada |
| Altana Pharma/Nycomed | Toronto | M4N3N5 | Canada |
| Altana Pharma/Nycomed | Toronto | M4P1P2 | Canada |
| Altana Pharma/Nycomed | Toronto | M9W 4L6 | Canada |
| Altana Pharma/Nycomed | Toronto on | M5S 2A5 | Canada |
| Altana Pharma/Nycomed | Beroun | 266 01 | Czechia |
| Altana Pharma/Nycomed | Cvikov | 471 54 | Czechia |
| Altana Pharma/Nycomed | Česká Lípa | 470 01 | Czechia |
| Altana Pharma/Nycomed | Havlickuv | 580 01 | Czechia |
| Altana Pharma/Nycomed | Jihlava | 58601 | Czechia |
| Altana Pharma/Nycomed | Jindřichův Hradec | 377 01 | Czechia |
| Altana Pharma/Nycomed | Karlovy Vary | 360 00 | Czechia |
| Altana Pharma/Nycomed | Kladno | 272 01 | Czechia |
| Altana Pharma/Nycomed | Kutná Hora | 28401 | Czechia |
| Altana Pharma/Nycomed | Ostrava-Marián.Hory | 70030 | Czechia |
| Altana Pharma/Nycomed | Prague | 100 00 | Czechia |
| Altana Pharma/Nycomed | Prague | 128 00 | Czechia |
| Altana Pharma/Nycomed | Prague | 14046 | Czechia |
| Altana Pharma/Nycomed | Prague | 181 00 | Czechia |
| Altana Pharma/Nycomed | Prague | 190 61 | Czechia |
| Altana Pharma/Nycomed | Pribram VI | 261 05 | Czechia |
| Altana Pharma/Nycomed | Príbram VIII | 261 01 | Czechia |
| Altana Pharma/Nycomed | Rokycany | 337 01 | Czechia |
| Altana Pharma/Nycomed | Strakonice | 38601 | Czechia |
| Altana Pharma/Nycomed | Trutnov | 54101 | Czechia |
| Altana Pharma/Nycomed | Ústí nad Labem | 401 13 | Czechia |
| Altana Pharma/Nycomed | Budapest | 1046 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1134 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1529 | Hungary |
| Altana Pharma/Nycomed | Budapest XI | 1117 | Hungary |
| Altana Pharma/Nycomed | Budapet | 1529 | Hungary |
| Altana Pharma/Nycomed | Kecskemét | 6000 | Hungary |
| Altana Pharma/Nycomed | Nyíregyháza | 4400 | Hungary |
| Altana Pharma/Nycomed | Szarvas | 5540 | Hungary |
| Altana Pharma/Nycomed | Tatabánya | 2800 | Hungary |
| Altana Pharma/Nycomed | Bydgoszcz | 85-091 | Poland |
| Altana Pharma/Nycomed | Bydgoszcz | 85-681 | Poland |
| Altana Pharma/Nycomed | Lodz | 91-520 | Poland |
| Altana Pharma/Nycomed | Lódz' | 90-153 | Poland |
| Altana Pharma/Nycomed | Rzeszów | 35-068 | Poland |
| Altana Pharma/Nycomed | Rzeszów | 35-302 | Poland |
| Altana Pharma/Nycomed | Warsaw | 01-138 | Poland |
| Altana Pharma/Nycomed | Wroclaw | 50-417 | Poland |
| Altana Pharma/Nycomed | Wroclaw | 53-674 | Poland |
| Altana Pharma/Nycomed | Arcadia, Pretoria | 132 | South Africa |
| Altana Pharma/Nycomed | Bellville, Cape Town | 7530 | South Africa |
| Altana Pharma/Nycomed | Berea, Durban | 4000 | South Africa |
| Altana Pharma/Nycomed | Bloemfontein | 9300 | South Africa |
| Altana Pharma/Nycomed | Bloemfontein | 9301 | South Africa |
| Altana Pharma/Nycomed | Cape Town | 7764 | South Africa |
| Altana Pharma/Nycomed | Centurion, Pretoria | 157 | South Africa |
| Altana Pharma/Nycomed | Daveyton | 1520 | South Africa |
| Altana Pharma/Nycomed | Durban, Amanzimtoti | 4126 | South Africa |
| Altana Pharma/Nycomed | George | 6539 | South Africa |
| Altana Pharma/Nycomed | Midrand | 1685 | South Africa |
| Altana Pharma/Nycomed | Mowbray, Cape Town | 7925 | South Africa |
| Altana Pharma/Nycomed | Paarl | 7646 | South Africa |
| Altana Pharma/Nycomed | Panorama / RSA-Cape Town | 7500 | South Africa |
| Altana Pharma/Nycomed | Pretoria | 186 | South Africa |
| Altana Pharma/Nycomed | Alcorcón (Madrid) | 28922 | Spain |
| Altana Pharma/Nycomed | Alicante | 3001 | Spain |
| Altana Pharma/Nycomed | Alicante | 3540 | Spain |
| Altana Pharma/Nycomed | Barcelona | 8222 | Spain |
| Altana Pharma/Nycomed | Campdevanol (Girona) | 17530 | Spain |
| Altana Pharma/Nycomed | Elda (Alicante) | 3600 | Spain |
| Altana Pharma/Nycomed | Guadalajara | 19002 | Spain |
| Altana Pharma/Nycomed | Leganes (Madrid) | 28914 | Spain |
| Altana Pharma/Nycomed | Palma de Mallorca | 7014 | Spain |
| Altana Pharma/Nycomed | Peralada (Girona) | 17491 | Spain |
| Altana Pharma/Nycomed | Petrer (Alicante) | 3610 | Spain |
| Altana Pharma/Nycomed | San Vicente Del Raspeig (Alicante) | 3187 | Spain |
| Altana Pharma/Nycomed | Santiago de Compostela | 15706 | Spain |
| Altana Pharma/Nycomed | Valencia | 46017 | Spain |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C120481 | ciclesonide |
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