Asthma Clinical Trial
— ATEMOfficial title:
Alvesco for the Therapy of Persistent Asthma With or Without Allergic Component
| Verified date | September 2016 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Observational |
The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent asthma including or excluding allergic components over 3 months, especially in the spring season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of Alvesco .
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | August 2011 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Main Inclusion Criteria: - Asthma with or without allergic components Main Exclusion Criteria: - Hypersensitive to compounds of Alvesco - Other criteria as defined in the Summary of Product Characteristics, Chapter 4.3 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Nycomed Pharma GmbH | Amstetten | |
| Austria | Nycomed Pharma GmbH | Baden | |
| Austria | Nycomed Pharma GmbH | Bludenz | |
| Austria | Nycomed Pharma GmbH | Böhlerwerk | |
| Austria | Nycomed Pharma GmbH | Braunau | |
| Austria | Nycomed Pharma GmbH | Bregenz | |
| Austria | Nycomed Pharma GmbH | Dornbirn | |
| Austria | Nycomed Pharma GmbH | Enns | |
| Austria | Nycomed Pharma GmbH | Feldbach | |
| Austria | Nycomed Pharma GmbH | Feldkirch | |
| Austria | Nycomed Pharma GmbH | Furth | |
| Austria | Nycomed Pharma GmbH | Gföhl | |
| Austria | Nycomed Pharma GmbH | Gr. Siegharts | |
| Austria | Nycomed Pharma GmbH | Graz | |
| Austria | Nycomed Pharma GmbH | Graz | |
| Austria | Nycomed Pharma GmbH | Graz | |
| Austria | Nycomed Pharma GmbH | Graz | |
| Austria | Nycomed Pharma GmbH | Graz-Gösting | |
| Austria | Nycomed Pharma GmbH | Groß Gerungs | |
| Austria | Nycomed Pharma GmbH | Gunskirchen | |
| Austria | Nycomed Pharma GmbH | Güssing | |
| Austria | Nycomed Pharma GmbH | Haag | |
| Austria | Nycomed Pharma GmbH | Hall in Tirol | |
| Austria | Nycomed Pharma GmbH | Hallein | |
| Austria | Nycomed Pharma GmbH | Hartberg | |
| Austria | Nycomed Pharma GmbH | Herzogenburg | |
| Austria | Nycomed Pharma GmbH | Innsbruck | |
| Austria | Nycomed Pharma GmbH | Judenburg | |
| Austria | Nycomed Pharma GmbH | Kaltenbach | |
| Austria | Nycomed Pharma GmbH | Kirchdorf and der Krems | |
| Austria | Nycomed Pharma GmbH | Kitzbühel | |
| Austria | Nycomed Pharma GmbH | Klein-Pöchlam | |
| Austria | Nycomed Pharma GmbH | Landeck | |
| Austria | Nycomed Pharma GmbH | Leibnitz | |
| Austria | Nycomed Pharma GmbH | Lenzing | |
| Austria | Nycomed Pharma GmbH | Linz | |
| Austria | Nycomed Pharma GmbH | Linz | |
| Austria | Nycomed Pharma GmbH | Linz | |
| Austria | Nycomed Pharma GmbH | Litschau | |
| Austria | Nycomed Pharma GmbH | Mank | |
| Austria | Nycomed Pharma GmbH | Melk | |
| Austria | Nycomed Pharma GmbH | Mittersill | |
| Austria | Nycomed Pharma GmbH | Mödling | |
| Austria | Nycomed Pharma GmbH | Mühldorf | |
| Austria | Nycomed Pharma GmbH | Munster | |
| Austria | Nycomed Pharma GmbH | Neumarkt | |
| Austria | Nycomed Pharma GmbH | Niederkreuzstetten | |
| Austria | Nycomed Pharma GmbH | Pasching | |
| Austria | Nycomed Pharma GmbH | Pinkafeld | |
| Austria | Nycomed Pharma GmbH | Pucking | |
| Austria | Nycomed Pharma GmbH | Salzburg | |
| Austria | Nycomed Pharma GmbH | Schlüßlberg | |
| Austria | Nycomed Pharma GmbH | Schörfling | |
| Austria | Nycomed Pharma GmbH | Schwanenstadt | |
| Austria | Nycomed Pharma GmbH | St. Johann i. Pg. | |
| Austria | Nycomed Pharma GmbH | St. Pölten | |
| Austria | Nycomed Pharma GmbH | St.Georgen i.A. | |
| Austria | Nycomed Pharma GmbH | Steyr | |
| Austria | Nycomed Pharma GmbH | Strallegg | |
| Austria | Nycomed Pharma GmbH | Sulz | |
| Austria | Nycomed Pharma GmbH | Thalheim bei Wels | |
| Austria | Nycomed Pharma GmbH | Traisen | |
| Austria | Nycomed Pharma GmbH | Traismauer | |
| Austria | Nycomed Pharma GmbH | Voitsberg | |
| Austria | Nycomed Pharma GmbH | Waidhofen/Thaya | |
| Austria | Nycomed Pharma GmbH | Weitra | |
| Austria | Nycomed Pharma GmbH | Wien | |
| Austria | Nycomed Pharma GmbH | Wien | |
| Austria | Nycomed Pharma GmbH | Wien | |
| Austria | Nycomed Pharma GmbH | Wien | |
| Austria | Nycomed Pharma GmbH | Wien | |
| Austria | Nycomed Pharma GmbH | Wien | |
| Austria | Nycomed Pharma GmbH | Wien | |
| Austria | Nycomed Pharma GmbH | Wien | |
| Austria | Nycomed Pharma GmbH | Wien | |
| Austria | Nycomed Pharma GmbH | Wiener Neustadt | |
| Austria | Nycomed Pharma GmbH | Wilhelmsburg | |
| Austria | Nycomed Pharma GmbH | Wr. Neustadt | |
| Austria | Nycomed Pharma GmbH | Yspertal | |
| Austria | Nycomed Pharma GmbH | Zwettl |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment success with Alvesco | Pre-/ post comparison of FEV1, Quality of life, Patient Questionnaire | after 3 months | No |
| Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | after 3 months | Yes |
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