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The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). 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 |
|---|---|---|
| number of patients with candidiasis of the oropharynx or hoarseness. |
| Measure | Description | Time Frame |
|---|---|---|
| inhaled Corticosteroids Questionnaire (ICQ) | ||
| proportion of cases of candidiasis of the oropharynx or | ||
| hoarseness at each visit Secondary variables |
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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 | Brussels | 1000 | Belgium | |||
| Altana Pharma/Nycomed |
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| Label | URL |
|---|---|
| BY9010-IT-101-RDS-2006-09-21.pdf | View source |
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| FEV1, FVC, PEF from spirometry |
| morning and evening PEF from diaries |
| diurnal PEF fluctuation |
| onset of treatment effect |
| percent days on which patient perceived asthma control |
| percent of nocturnal awakening-free days |
| percent of rescue medication free days |
| percent symptom free days |
| asthma symptom score |
| use of rescue medication |
| time to first asthma exacerbation |
| number of patients with an asthma exacerbation |
| AQLQ |
| number of patients with candidiasis of the oropharynx or hoarseness by severity |
| physical examination, ECG |
| vital sings |
| adverse events |
| standard laboratory work-up |
| morning serum cortisol |
| skin bruising. |
| Brussels |
| 1040 |
| Belgium |
| Altana Pharma/Nycomed | Brussels | 1190 | Belgium |
| Altana Pharma/Nycomed | Halen | 3545 | Belgium |
| Altana Pharma/Nycomed | Jette | 1090 | Belgium |
| Altana Pharma/Nycomed | Maison-Saint-Gérard | 5640 | Belgium |
| Altana Pharma/Nycomed | Namur | 5000 | Belgium |
| Altana Pharma/Nycomed | Ostend | 8400 | Belgium |
| Altana Pharma/Nycomed | Turnhout | 2300 | Belgium |
| Altana Pharma/Nycomed | Veurne | 8630 | Belgium |
| Altana Pharma/Nycomed | Aix-en-Provence | 13090 | France |
| Altana Pharma/Nycomed | Béziers | 34500 | France |
| Altana Pharma/Nycomed | Chauny | 2303 | France |
| Altana Pharma/Nycomed | Grasse | 6130 | France |
| Altana Pharma/Nycomed | La Rochelle | 17000 | France |
| Altana Pharma/Nycomed | Marseille | 13008 | France |
| Altana Pharma/Nycomed | Martigues | 13695 | France |
| Altana Pharma/Nycomed | Metz | 57000 | France |
| Altana Pharma/Nycomed | Montfermeil | 93370 | France |
| Altana Pharma/Nycomed | Montpellier | 34070 | France |
| Altana Pharma/Nycomed | Nice | 6000 | France |
| Altana Pharma/Nycomed | Nîmes | 30900 | France |
| Altana Pharma/Nycomed | Paris | 75014 | France |
| Altana Pharma/Nycomed | Perpignan | 66046 | France |
| Altana Pharma/Nycomed | Vieux-Condé | 59690 | France |
| Altana Pharma/Nycomed | Ancona | 60100 | Italy |
| Altana Pharma/Nycomed | Brescia | 25123 | Italy |
| Altana Pharma/Nycomed | Chieti | 66100 | Italy |
| Altana Pharma/Nycomed | Florence | 50134 | Italy |
| Altana Pharma/Nycomed | Livorno | 57124 | Italy |
| Altana Pharma/Nycomed | Milan | 20122 | Italy |
| Altana Pharma/Nycomed | Milan | 20142 | Italy |
| Altana Pharma/Nycomed | Milazzo (ME) | 98057 | Italy |
| Altana Pharma/Nycomed | Naples | 80131 | Italy |
| Altana Pharma/Nycomed | Pavia | 27100 | Italy |
| Altana Pharma/Nycomed | Pirri-Cagliari | 9134 | Italy |
| Altana Pharma/Nycomed | Pordenone | 33170 | Italy |
| Altana Pharma/Nycomed | Roma | 100 | Italy |
| Altana Pharma/Nycomed | Verona | 30012 | Italy |
| Altana Pharma/Nycomed | Almere Stad | 1315 RA | Netherlands |
| Altana Pharma/Nycomed | Haarlem | 2012 CE | Netherlands |
| Altana Pharma/Nycomed | Harderwijk | 3844 DG | Netherlands |
| Altana Pharma/Nycomed | Heerlen | 6419 PC | Netherlands |
| Altana Pharma/Nycomed | Helmond | 5707 HA | Netherlands |
| Altana Pharma/Nycomed | Schiedam | 3116 BA | Netherlands |
| Altana Pharma/Nycomed | Utrecht | 3584 CX | Netherlands |
| Altana Pharma/Nycomed | Veldhoven | 5504 DB | Netherlands |
| Altana Pharma/Nycomed | Almería | 4009 | Spain |
| Altana Pharma/Nycomed | Barcelona | 8222 | Spain |
| Altana Pharma/Nycomed | Córdoba | 14004 | Spain |
| Altana Pharma/Nycomed | Elche | 3203 | Spain |
| Altana Pharma/Nycomed | Guadalajara | 19002 | Spain |
| Altana Pharma/Nycomed | Madrid | 28001 | Spain |
| Altana Pharma/Nycomed | Madrid | 28006 | Spain |
| Altana Pharma/Nycomed | Madrid | 28040 | Spain |
| Altana Pharma/Nycomed | Madrid | 28047 | Spain |
| Altana Pharma/Nycomed | Requena | 46340 | Spain |
| Altana Pharma/Nycomed | San Sebastián | 20014 | Spain |
| Altana Pharma/Nycomed | Valencia | 46014 | Spain |
| Altana Pharma/Nycomed | Valencia | 46017 | Spain |
| Altana Pharma/Nycomed | Basel | 4031 | Switzerland |
| Altana Pharma/Nycomed | Bellinzona | 6500 | Switzerland |
| Altana Pharma/Nycomed | Bern | 3012 | Switzerland |
| Altana Pharma/Nycomed | Bruderholz | 4101 | Switzerland |
| Altana Pharma/Nycomed | La Chauxe-de-Fonds | 2300 | Switzerland |
| Altana Pharma/Nycomed | Lugano | 6900 | Switzerland |
| Altana Pharma/Nycomed | Münchenstein | 4142 | Switzerland |
| Altana Pharma/Nycomed | Münsingen | 3110 | Switzerland |
| Altana Pharma/Nycomed | Münsterlingen | 8596 | Switzerland |
| Altana Pharma/Nycomed | Zurich | 8048 | Switzerland |
| Altana Pharma/Nycomed | Zurich | 8050 | Switzerland |
| Altana Pharma/Nycomed | Zurich | 8063 | Switzerland |
| Altana Pharma/Nycomed | Belfast | BT7 1DA | United Kingdom |
| Altana Pharma/Nycomed | Belfast, Irland | BT15 3LL | United Kingdom |
| Altana Pharma/Nycomed | Bradford on Avon, Wiltshire | BA15 1DQ | United Kingdom |
| Altana Pharma/Nycomed | Chesterfield Derbyshire | S40 4TF | United Kingdom |
| Altana Pharma/Nycomed | Chippenham, Wiltshire | SN15 2SB | United Kingdom |
| Altana Pharma/Nycomed | Co. Antrim | BT38 8TP | United Kingdom |
| Altana Pharma/Nycomed | Downpatrick, Northern Ireland | BT30 6HY | United Kingdom |
| Altana Pharma/Nycomed | Dronfield | S18 1RU | United Kingdom |
| Altana Pharma/Nycomed | Glengormley | BT36 4PP | United Kingdom |
| Altana Pharma/Nycomed | Glengormley Newtownabbey | BT36 5EQ | United Kingdom |
| Altana Pharma/Nycomed | Hastings | TN34 3EY | United Kingdom |
| Altana Pharma/Nycomed | Maidenhead, Berks | SI6 2LH | United Kingdom |
| Altana Pharma/Nycomed | Nottingham | NG3 7DQ | United Kingdom |
| Altana Pharma/Nycomed | Nottingham | NG5 1PB | United Kingdom |
| Altana Pharma/Nycomed | Solihull | B91 2JL | United Kingdom |
| Altana Pharma/Nycomed | Warminster Wiltshire | BA12 9AA | United Kingdom |
| Altana Pharma/Nycomed | Watford | WD25 0EA | United Kingdom |
| 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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