Asthma Clinical Trial
— ARTISTOfficial title:
Ciclesonide for the Therapy of Asthma During the Cold Season.
| Verified date | September 2016 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Observational |
The aim of the study is to evaluate the efficacy of ciclesonide in patients with persistent asthma over 3 months, especially in the cold season. Ciclesonide will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of ciclesonide.
| Status | Completed |
| Enrollment | 2100 |
| Est. completion date | August 2008 |
| Est. primary completion date | August 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Main inclusion criteria: - History of persistent bronchial asthma Main exclusion criteria: - Hypersensitive to compounds of Alvesco - Other criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3) |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | "Nycomed Deutschland GmbH" | Adendorf | |
| Germany | "Nycomed Deutschland GmbH" | Arnstadt | |
| Germany | "Nycomed Deutschland GmbH" | Auerbach | |
| Germany | "Nycomed Deutschland GmbH" | Augsburg | |
| Germany | "Nycomed Deutschland GmbH" | Backnang | |
| Germany | "Nycomed Deutschland GmbH" | Bad Bramstedt | |
| Germany | "Nycomed Deutschland GmbH" | Bad Kreuznach | |
| Germany | "Nycomed Deutschland GmbH" | Bad Lippspringe | |
| Germany | "Nycomed Deutschland GmbH" | Bad Neuenahr-Ahrweiler | |
| Germany | "Nycomed Deutschland GmbH" | Bad Neustadt | |
| Germany | "Nycomed Deutschland GmbH" | Bad Soden | |
| Germany | "Nycomed Deutschland GmbH" | Bad Tölz | |
| Germany | "Nycomed Deutschland GmbH" | Bautzen | |
| Germany | "Nycomed Deutschland GmbH" | Bergisch Gladbach | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Berlin | |
| Germany | "Nycomed Deutschland GmbH" | Bietigheim-Bissingen | |
| Germany | "Nycomed Deutschland GmbH" | Braunschweig | |
| Germany | "Nycomed Deutschland GmbH" | Braunschweig | |
| Germany | "Nycomed Deutschland GmbH" | Bredstedt | |
| Germany | "Nycomed Deutschland GmbH" | Breisach | |
| Germany | "Nycomed Deutschland GmbH" | Bremen | |
| Germany | "Nycomed Deutschland GmbH" | Bremen | |
| Germany | "Nycomed Deutschland GmbH" | Bremerhaven | |
| Germany | "Nycomed Deutschland GmbH" | Bremerhaven | |
| Germany | "Nycomed Deutschland GmbH" | Bröckel | |
| Germany | "Nycomed Deutschland GmbH" | Bruchsal | |
| Germany | "Nycomed Deutschland GmbH" | Burgwedel | |
| Germany | "Nycomed Deutschland GmbH" | Castrop-Rauxel | |
| Germany | "Nycomed Deutschland GmbH" | Coburg | |
| Germany | "Nycomed Deutschland GmbH" | Cottbus | |
| Germany | "Nycomed Deutschland GmbH" | Delitzsch | |
| Germany | "Nycomed Deutschland GmbH" | Dortmund | |
| Germany | "Nycomed Deutschland GmbH" | Dortmund | |
| Germany | "Nycomed Deutschland GmbH" | Dresden | |
| Germany | "Nycomed Deutschland GmbH" | Dresden | |
| Germany | "Nycomed Deutschland GmbH" | Duisburg | |
| Germany | "Nycomed Deutschland GmbH" | Düren | |
| Germany | "Nycomed Deutschland GmbH" | Düsseldorf | |
| Germany | "Nycomed Deutschland GmbH" | Eisenach | |
| Germany | "Nycomed Deutschland GmbH" | Erfurt | |
| Germany | "Nycomed Deutschland GmbH" | Eschwege | |
| Germany | "Nycomed Deutschland GmbH" | Finsterwalde | |
| Germany | "Nycomed Deutschland GmbH" | Flensburg | |
| Germany | "Nycomed Deutschland GmbH" | Frankfurt | |
| Germany | "Nycomed Deutschland GmbH" | Freising | |
| Germany | "Nycomed Deutschland GmbH" | Friedrichshafen | |
| Germany | "Nycomed Deutschland GmbH" | Fürstenwalde | |
| Germany | "Nycomed Deutschland GmbH" | Garmisch-Partenkirchen | |
| Germany | "Nycomed Deutschland GmbH" | Gelsenkirchen | |
| Germany | "Nycomed Deutschland GmbH" | Gotha | |
| Germany | "Nycomed Deutschland GmbH" | Greiz | |
| Germany | "Nycomed Deutschland GmbH" | Hagen | |
| Germany | "Nycomed Deutschland GmbH" | Halle | |
| Germany | "Nycomed Deutschland GmbH" | Halle | |
| Germany | "Nycomed Deutschland GmbH" | Hamburg | |
| Germany | "Nycomed Deutschland GmbH" | Hamburg | |
| Germany | "Nycomed Deutschland GmbH" | Hamburg | |
| Germany | "Nycomed Deutschland GmbH" | Hannover | |
| Germany | "Nycomed Deutschland GmbH" | Hartha | |
| Germany | "Nycomed Deutschland GmbH" | Haßloch | |
| Germany | "Nycomed Deutschland GmbH" | Heidelberg | |
| Germany | "Nycomed Deutschland GmbH" | Heilbronn | |
| Germany | "Nycomed Deutschland GmbH" | Herne | |
| Germany | "Nycomed Deutschland GmbH" | Herten | |
| Germany | "Nycomed Deutschland GmbH" | Höchstadt | |
| Germany | "Nycomed Deutschland GmbH" | Hoyerswerda | |
| Germany | "Nycomed Deutschland GmbH" | Husum | |
| Germany | "Nycomed Deutschland GmbH" | Jettingen | |
| Germany | "Nycomed Deutschland GmbH" | Karlsruhe | |
| Germany | "Nycomed Deutschland GmbH" | Kiel | |
| Germany | "Nycomed Deutschland GmbH" | Kiel | |
| Germany | "Nycomed Deutschland GmbH" | Koblenz | |
| Germany | "Nycomed Deutschland GmbH" | Köln | |
| Germany | "Nycomed Deutschland GmbH" | Köln | |
| Germany | "Nycomed Deutschland GmbH" | Konstanz | |
| Germany | "Nycomed Deutschland GmbH" | Laatzen | |
| Germany | "Nycomed Deutschland GmbH" | Leipzig | |
| Germany | "Nycomed Deutschland GmbH" | Leipzig | |
| Germany | "Nycomed Deutschland GmbH" | Leipzig | |
| Germany | "Nycomed Deutschland GmbH" | Leipzig | |
| Germany | "Nycomed Deutschland GmbH" | Limburg | |
| Germany | "Nycomed Deutschland GmbH" | Lohfelden | |
| Germany | "Nycomed Deutschland GmbH" | Mainz | |
| Germany | "Nycomed Deutschland GmbH" | Mainz | |
| Germany | "Nycomed Deutschland GmbH" | Mannheim | |
| Germany | "Nycomed Deutschland GmbH" | Mannheim | |
| Germany | "Nycomed Deutschland GmbH" | Marburg | |
| Germany | "Nycomed Deutschland GmbH" | Markkleeberg | |
| Germany | "Nycomed Deutschland GmbH" | Menden | |
| Germany | "Nycomed Deutschland GmbH" | Minden | |
| Germany | "Nycomed Deutschland GmbH" | Moers | |
| Germany | "Nycomed Deutschland GmbH" | Mühlhausen | |
| Germany | "Nycomed Deutschland GmbH" | München | |
| Germany | "Nycomed Deutschland GmbH" | Neu Wulmstorf | |
| Germany | "Nycomed Deutschland GmbH" | Neubrandenburg | |
| Germany | "Nycomed Deutschland GmbH" | Neumarkt | |
| Germany | "Nycomed Deutschland GmbH" | Neuruppin | |
| Germany | "Nycomed Deutschland GmbH" | Neuss | |
| Germany | "Nycomed Deutschland GmbH" | Nordhausen | |
| Germany | "Nycomed Deutschland GmbH" | Oberursel | |
| Germany | "Nycomed Deutschland GmbH" | Offenburg | |
| Germany | "Nycomed Deutschland GmbH" | Osnabrück | |
| Germany | "Nycomed Deutschland GmbH" | Plauen | |
| Germany | "Nycomed Deutschland GmbH" | Radebeul | |
| Germany | "Nycomed Deutschland GmbH" | Rendsburg | |
| Germany | "Nycomed Deutschland GmbH" | Rosengarten | |
| Germany | "Nycomed Deutschland GmbH" | Rostock | |
| Germany | "Nycomed Deutschland GmbH" | Saalfeld | |
| Germany | "Nycomed Deutschland GmbH" | Saarbrücken | |
| Germany | "Nycomed Deutschland GmbH" | Saarlouis | |
| Germany | "Nycomed Deutschland GmbH" | Salzgitter | |
| Germany | "Nycomed Deutschland GmbH" | Schmölln | |
| Germany | "Nycomed Deutschland GmbH" | Schwalmtal | |
| Germany | "Nycomed Deutschland GmbH" | Schwarmstedt | |
| Germany | "Nycomed Deutschland GmbH" | Schwerin | |
| Germany | "Nycomed Deutschland GmbH" | Siegen | |
| Germany | "Nycomed Deutschland GmbH" | Sinsheim | |
| Germany | "Nycomed Deutschland GmbH" | Solingen | |
| Germany | "Nycomed Deutschland GmbH" | Sonneberg | |
| Germany | "Nycomed Deutschland GmbH" | Stadthagen | |
| Germany | "Nycomed Deutschland GmbH" | Starnberg | |
| Germany | "Nycomed Deutschland GmbH" | Steißlingen | |
| Germany | "Nycomed Deutschland GmbH" | Straelen | |
| Germany | "Nycomed Deutschland GmbH" | Stuttgart | |
| Germany | "Nycomed Deutschland GmbH" | Stuttgart | |
| Germany | "Nycomed Deutschland GmbH" | Stuttgart | |
| Germany | "Nycomed Deutschland GmbH" | Teterow | |
| Germany | "Nycomed Deutschland GmbH" | Teuchern | |
| Germany | "Nycomed Deutschland GmbH" | Uelzen | |
| Germany | "Nycomed Deutschland GmbH" | Ulm | |
| Germany | "Nycomed Deutschland GmbH" | Umkirch | |
| Germany | "Nycomed Deutschland GmbH" | Villingen-Schwenningen | |
| Germany | "Nycomed Deutschland GmbH" | Vilshofen | |
| Germany | "Nycomed Deutschland GmbH" | Wallertheim | |
| Germany | "Nycomed Deutschland GmbH" | Wilhelmshaven | |
| Germany | "Nycomed Deutschland GmbH" | Witten | |
| Germany | "Nycomed Deutschland GmbH" | Wörrstadt | |
| Germany | "Nycomed Deutschland GmbH" | Wörth | |
| Germany | "Nycomed Deutschland GmbH" | Würzburg |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FEV1, symptom score assessment | within 3 months | ||
| Secondary | Handling of the metered-dose inhaler, safety and tolerability | within 3 months |
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