Asthma Clinical Trial
Official title:
Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma
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.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | November 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Main Inclusion Criteria: - Written informed consent - History of bronchial asthma for at least 6 months - Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) = 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination - FEV1 = 80% of predicted Main Exclusion Criteria: - Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs - COPD - Smoking with =10 pack-years - Pregnancy - Intention to become pregnant during the course of the study - Breast feeding - Lack of safe contraception |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Altana Pharma/Nycomed | Bruxelles | |
| Belgium | Altana Pharma/Nycomed | Bruxelles | |
| Belgium | Altana Pharma/Nycomed | Bruxelles | |
| Belgium | Altana Pharma/Nycomed | Halen | |
| Belgium | Altana Pharma/Nycomed | Jette | |
| Belgium | Altana Pharma/Nycomed | Maison-Saint-Gérard | |
| Belgium | Altana Pharma/Nycomed | Namur | |
| Belgium | Altana Pharma/Nycomed | Oostende | |
| Belgium | Altana Pharma/Nycomed | Turnhout | |
| Belgium | Altana Pharma/Nycomed | Veurne | |
| France | Altana Pharma/Nycomed | Aix En Provence | |
| France | Altana Pharma/Nycomed | Beziers | |
| France | Altana Pharma/Nycomed | Chauny CEDEX | |
| France | Altana Pharma/Nycomed | Grasse | |
| France | Altana Pharma/Nycomed | La Rochelle | |
| France | Altana Pharma/Nycomed | Marseille | |
| France | Altana Pharma/Nycomed | Martigues Cedex | |
| France | Altana Pharma/Nycomed | Metz | |
| France | Altana Pharma/Nycomed | Montfermeil | |
| France | Altana Pharma/Nycomed | Montpellier Cedex | |
| France | Altana Pharma/Nycomed | Nice | |
| France | Altana Pharma/Nycomed | Nimes | |
| France | Altana Pharma/Nycomed | Paris | |
| France | Altana Pharma/Nycomed | Perpignan CEDEX | |
| France | Altana Pharma/Nycomed | Vieux Conde | |
| Italy | Altana Pharma/Nycomed | Ancona | |
| Italy | Altana Pharma/Nycomed | Brescia | |
| Italy | Altana Pharma/Nycomed | Chieti | |
| Italy | Altana Pharma/Nycomed | Firenze | |
| Italy | Altana Pharma/Nycomed | Livorno | |
| Italy | Altana Pharma/Nycomed | Milano | |
| Italy | Altana Pharma/Nycomed | Milano | |
| Italy | Altana Pharma/Nycomed | Milazzo (ME) | |
| Italy | Altana Pharma/Nycomed | Napoli | |
| Italy | Altana Pharma/Nycomed | Pavia | |
| Italy | Altana Pharma/Nycomed | Pirri-Cagliari | |
| Italy | Altana Pharma/Nycomed | Pordenone | |
| Italy | Altana Pharma/Nycomed | Roma | |
| Italy | Altana Pharma/Nycomed | Verona | |
| Netherlands | Altana Pharma/Nycomed | Almere | |
| Netherlands | Altana Pharma/Nycomed | Haarlem | |
| Netherlands | Altana Pharma/Nycomed | Harderwijk | |
| Netherlands | Altana Pharma/Nycomed | Heerlen | |
| Netherlands | Altana Pharma/Nycomed | Helmond | |
| Netherlands | Altana Pharma/Nycomed | Schiedam | |
| Netherlands | Altana Pharma/Nycomed | Utrecht | |
| Netherlands | Altana Pharma/Nycomed | Veldhoven | |
| Spain | Altana Pharma/Nycomed | Almeria | |
| Spain | Altana Pharma/Nycomed | Barcelona | |
| Spain | Altana Pharma/Nycomed | Córdoba | |
| Spain | Altana Pharma/Nycomed | Elche | |
| Spain | Altana Pharma/Nycomed | Guadalajara | |
| Spain | Altana Pharma/Nycomed | Madrid | |
| Spain | Altana Pharma/Nycomed | Madrid | |
| Spain | Altana Pharma/Nycomed | Madrid | |
| Spain | Altana Pharma/Nycomed | Madrid | |
| Spain | Altana Pharma/Nycomed | Requena | |
| Spain | Altana Pharma/Nycomed | San Sebastián | |
| Spain | Altana Pharma/Nycomed | Valencia | |
| Spain | Altana Pharma/Nycomed | Valencia | |
| Switzerland | Altana Pharma/Nycomed | Basel | |
| Switzerland | Altana Pharma/Nycomed | Bellinzona | |
| Switzerland | Altana Pharma/Nycomed | Bern | |
| Switzerland | Altana Pharma/Nycomed | Bruderholz | |
| Switzerland | Altana Pharma/Nycomed | La Chauxe-de-Fonds | |
| Switzerland | Altana Pharma/Nycomed | Lugano | |
| Switzerland | Altana Pharma/Nycomed | Münchenstein | |
| Switzerland | Altana Pharma/Nycomed | Münsingen | |
| Switzerland | Altana Pharma/Nycomed | Münsterlingen | |
| Switzerland | Altana Pharma/Nycomed | Zürich | |
| Switzerland | Altana Pharma/Nycomed | Zürich | |
| Switzerland | Altana Pharma/Nycomed | Zürich | |
| United Kingdom | Altana Pharma/Nycomed | Belfast | |
| United Kingdom | Altana Pharma/Nycomed | Belfast, Irland | |
| United Kingdom | Altana Pharma/Nycomed | Bradford on Avon, Wiltshire | |
| United Kingdom | Altana Pharma/Nycomed | Chesterfield Derbyshire | |
| United Kingdom | Altana Pharma/Nycomed | Chippenham, Wiltshire | |
| United Kingdom | Altana Pharma/Nycomed | Co. Antrim | |
| United Kingdom | Altana Pharma/Nycomed | Downpatrick, Northern Ireland | |
| United Kingdom | Altana Pharma/Nycomed | Dronfield | |
| United Kingdom | Altana Pharma/Nycomed | Glengormley | |
| United Kingdom | Altana Pharma/Nycomed | Glengormley Newtownabbey | |
| United Kingdom | Altana Pharma/Nycomed | Hastings | |
| United Kingdom | Altana Pharma/Nycomed | Maidenhead, Berks | |
| United Kingdom | Altana Pharma/Nycomed | Nottingham | |
| United Kingdom | Altana Pharma/Nycomed | Nottingham | |
| United Kingdom | Altana Pharma/Nycomed | Solihull | |
| United Kingdom | Altana Pharma/Nycomed | Warminster Wiltshire | |
| United Kingdom | Altana Pharma/Nycomed | Watford |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Belgium, France, Italy, Netherlands, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number of patients with candidiasis of the oropharynx or hoarseness. | |||
| Secondary | inhaled Corticosteroids Questionnaire (ICQ) | |||
| Secondary | proportion of cases of candidiasis of the oropharynx or | |||
| Secondary | hoarseness at each visit Secondary variables | |||
| Secondary | FEV1, FVC, PEF from spirometry | |||
| Secondary | morning and evening PEF from diaries | |||
| Secondary | diurnal PEF fluctuation | |||
| Secondary | onset of treatment effect | |||
| Secondary | percent days on which patient perceived asthma control | |||
| Secondary | percent of nocturnal awakening-free days | |||
| Secondary | percent of rescue medication free days | |||
| Secondary | percent symptom free days | |||
| Secondary | asthma symptom score | |||
| Secondary | use of rescue medication | |||
| Secondary | time to first asthma exacerbation | |||
| Secondary | number of patients with an asthma exacerbation | |||
| Secondary | AQLQ | |||
| Secondary | number of patients with candidiasis of the oropharynx or hoarseness by severity | |||
| Secondary | physical examination, ECG | |||
| Secondary | vital sings | |||
| Secondary | adverse events | |||
| Secondary | standard laboratory work-up | |||
| Secondary | morning serum cortisol | |||
| Secondary | skin bruising. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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