Asthma Clinical Trial
Official title:
Comparison of the Efficacy and Safety of 160 mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma
| Verified date | October 2016 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).
| Status | Completed |
| Enrollment | 450 |
| Est. completion date | January 2006 |
| Est. primary completion date | January 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 75 Years |
| Eligibility |
Main Inclusion Criteria: - Written informed consent - History of persistent bronchial asthma for at least 6 months - Good health with the exception of asthma Main Exclusion Criteria: - Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids - Smoking history with =10 cigarette pack years - Pregnancy - Intention to become pregnant - Breast feeding - Lack of safe contraception - Previous enrolment into the current study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Altana Pharma/Nycomed | La Malbaie, Quebec | |
| Canada | Altana Pharma/Nycomed | London | |
| Canada | Altana Pharma/Nycomed | London,ON | |
| Canada | Altana Pharma/Nycomed | Mississauga | |
| Canada | Altana Pharma/Nycomed | Montreal, Quebec | |
| Canada | Altana Pharma/Nycomed | Quebec City | |
| Canada | Altana Pharma/Nycomed | Richmond Hill | |
| Canada | Altana Pharma/Nycomed | Sainte-Foy, Quebec | |
| Canada | Altana Pharma/Nycomed | Saskatoon,SK | |
| Canada | Altana Pharma/Nycomed | Scarborough,ON | |
| Canada | Altana Pharma/Nycomed | Toronto | |
| Canada | Altana Pharma/Nycomed | Vancouver, BC | |
| Canada | Altana Pharma/Nycomed | Winnipeg | |
| Canada | Altana Pharma/Nycomed | Winnipeg MB | |
| Canada | Altana Pharma/Nycomed | Woodstock | |
| France | Altana Pharma/Nycomed | Aix En Provence | |
| France | Altana Pharma/Nycomed | Chauny CEDEX | |
| France | Altana Pharma/Nycomed | Ferolles-Attily | |
| France | Altana Pharma/Nycomed | Grasse | |
| France | Altana Pharma/Nycomed | La Rochelle | |
| France | Altana Pharma/Nycomed | La Teste de Buch | |
| France | Altana Pharma/Nycomed | Libourne | |
| France | Altana Pharma/Nycomed | Lille | |
| France | Altana Pharma/Nycomed | Martigues Cedex | |
| France | Altana Pharma/Nycomed | Montbrison | |
| France | Altana Pharma/Nycomed | Montpellier Cedex | |
| France | Altana Pharma/Nycomed | Nice | |
| France | Altana Pharma/Nycomed | Nimes | |
| France | Altana Pharma/Nycomed | Saint Laurent Du Var | |
| France | Altana Pharma/Nycomed | Saint-Quentin | |
| Germany | Altana Pharma/Nycomed | Berlin | |
| Germany | Altana Pharma/Nycomed | Berlin | |
| Germany | Altana Pharma/Nycomed | Oschersleben | |
| Germany | Altana Pharma/Nycomed | Rüdersdorf | |
| Germany | Altana Pharma/Nycomed | Schwetzingen | |
| Germany | Altana Pharma/Nycomed | Weinheim | |
| Hungary | Altana Pharma/Nycomed | Balassagyarmat | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Budapet | |
| Hungary | Altana Pharma/Nycomed | Érd | |
| Hungary | Altana Pharma/Nycomed | Gyula | |
| Hungary | Altana Pharma/Nycomed | Komárom | |
| Hungary | Altana Pharma/Nycomed | Miskolc | |
| Hungary | Altana Pharma/Nycomed | Mosdós | |
| Hungary | Altana Pharma/Nycomed | Nyiregyháza | |
| Hungary | Altana Pharma/Nycomed | Pécs | |
| Hungary | Altana Pharma/Nycomed | Szeged | |
| Hungary | Altana Pharma/Nycomed | Székesfehérvár | |
| India | Altana Pharma/Nycomed | Bangalore | |
| India | Altana Pharma/Nycomed | Chennai | |
| India | Altana Pharma/Nycomed | Coimbatore | |
| India | Altana Pharma/Nycomed | Coimbatore | |
| India | Altana Pharma/Nycomed | Coimbatore, Tamilnadu | |
| India | Altana Pharma/Nycomed | Goa | |
| India | Altana Pharma/Nycomed | Gulbarga | |
| India | Altana Pharma/Nycomed | Mumbai | |
| India | Altana Pharma/Nycomed | Mumbai, Dadar (E) | |
| India | Altana Pharma/Nycomed | Pune | |
| Italy | Altana Pharma/Nycomed | Firenze | |
| Italy | Altana Pharma/Nycomed | Milano | |
| Italy | Altana Pharma/Nycomed | Milano | |
| Italy | Altana Pharma/Nycomed | Milano | |
| Italy | Altana Pharma/Nycomed | Napoli | |
| Italy | Altana Pharma/Nycomed | Pordenone | |
| Italy | Altana Pharma/Nycomed | Verona |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Canada, France, Germany, Hungary, India, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FEV1. | |||
| Secondary | FVC | |||
| Secondary | morning and evening PEF from diaries | |||
| Secondary | asthma symptom score | |||
| Secondary | use of rescue medication | |||
| Secondary | number of patients with an asthma exacerbation | |||
| Secondary | time to the first asthma exacerbation | |||
| Secondary | percentage of days on which patient perceived asthma control | |||
| Secondary | percentage of nocturnal awakening-free days | |||
| Secondary | percentage of rescue medication-free days | |||
| Secondary | percentage of asthma symptom-free days | |||
| Secondary | adverse events | |||
| Secondary | physical examination | |||
| Secondary | vital signs | |||
| Secondary | standard laboratory work-up | |||
| Secondary | 8 am serum cortisol. |
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