Clinical trial NCT01147224: ATEM (Alvesco Non-interventional Study)
Official title: Alvesco for the Therapy of Persistent Asthma With or Without Allergic Component
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Allergy
Keywords: Asthma
Allergy
Ciclesonide
Alvesco
Inhaled steroids
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients

Brief summary: 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 .


Eligibility criteria: 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

Primary outcomes:
measure: Treatment success with Alvesco
timeFrame: after 3 months
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: after 3 months
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Nycomed Pharma GmbH
city: Baden
country: Austria
facility: Nycomed Pharma GmbH
city: Bludenz
country: Austria
facility: Nycomed Pharma GmbH
city: Braunau
country: Austria
facility: Nycomed Pharma GmbH
city: Bregenz
country: Austria
facility: Nycomed Pharma GmbH
city: Böhlerwerk
country: Austria
facility: Nycomed Pharma GmbH
city: Dornbirn
country: Austria
facility: Nycomed Pharma GmbH
city: Enns
country: Austria
facility: Nycomed Pharma GmbH
city: Feldbach
country: Austria
facility: Nycomed Pharma GmbH
city: Feldkirch
country: Austria
facility: Nycomed Pharma GmbH
city: Furth
country: Austria
facility: Nycomed Pharma GmbH
city: Gföhl
country: Austria
facility: Nycomed Pharma GmbH
city: Gr. Siegharts
country: Austria
facility: Nycomed Pharma GmbH
city: Graz-Gösting
country: Austria
facility: Nycomed Pharma GmbH
city: Graz
country: Austria
facility: Nycomed Pharma GmbH
city: Graz
country: Austria
facility: Nycomed Pharma GmbH
city: Graz
country: Austria
facility: Nycomed Pharma GmbH
city: Graz
country: Austria
facility: Nycomed Pharma GmbH
city: Groß Gerungs
country: Austria
facility: Nycomed Pharma GmbH
city: Gunskirchen
country: Austria
facility: Nycomed Pharma GmbH
city: Güssing
country: Austria
facility: Nycomed Pharma GmbH
city: Haag
country: Austria
facility: Nycomed Pharma GmbH
city: Hall in Tirol
country: Austria
facility: Nycomed Pharma GmbH
city: Hallein
country: Austria
facility: Nycomed Pharma GmbH
city: Hartberg
country: Austria
facility: Nycomed Pharma GmbH
city: Herzogenburg
country: Austria
facility: Nycomed Pharma GmbH
city: Innsbruck
country: Austria
facility: Nycomed Pharma GmbH
city: Judenburg
country: Austria
facility: Nycomed Pharma GmbH
city: Kaltenbach
country: Austria
facility: Nycomed Pharma GmbH
city: Kirchdorf and der Krems
country: Austria
facility: Nycomed Pharma GmbH
city: Kitzbühel
country: Austria
facility: Nycomed Pharma GmbH
city: Klein-Pöchlam
country: Austria
facility: Nycomed Pharma GmbH
city: Landeck
country: Austria
facility: Nycomed Pharma GmbH
city: Leibnitz
country: Austria
facility: Nycomed Pharma GmbH
city: Lenzing
country: Austria
facility: Nycomed Pharma GmbH
city: Linz
country: Austria
facility: Nycomed Pharma GmbH
city: Linz
country: Austria
facility: Nycomed Pharma GmbH
city: Linz
country: Austria
facility: Nycomed Pharma GmbH
city: Litschau
country: Austria
facility: Nycomed Pharma GmbH
city: Mank
country: Austria
facility: Nycomed Pharma GmbH
city: Melk
country: Austria
facility: Nycomed Pharma GmbH
city: Mittersill
country: Austria
facility: Nycomed Pharma GmbH
city: Munster
country: Austria
facility: Nycomed Pharma GmbH
city: Mödling
country: Austria
facility: Nycomed Pharma GmbH
city: Mühldorf
country: Austria
facility: Nycomed Pharma GmbH
city: Neumarkt
country: Austria
facility: Nycomed Pharma GmbH
city: Niederkreuzstetten
country: Austria
facility: Nycomed Pharma GmbH
city: Pasching
country: Austria
facility: Nycomed Pharma GmbH
city: Pinkafeld
country: Austria
facility: Nycomed Pharma GmbH
city: Pucking
country: Austria
facility: Nycomed Pharma GmbH
city: Salzburg
country: Austria
facility: Nycomed Pharma GmbH
city: Schlüßlberg
country: Austria
facility: Nycomed Pharma GmbH
city: Schwanenstadt
country: Austria
facility: Nycomed Pharma GmbH
city: Schörfling
country: Austria
facility: Nycomed Pharma GmbH
city: St. Johann i. Pg.
country: Austria
facility: Nycomed Pharma GmbH
city: St. Pölten
country: Austria
facility: Nycomed Pharma GmbH
city: St.Georgen i.A.
country: Austria
facility: Nycomed Pharma GmbH
city: Steyr
country: Austria
facility: Nycomed Pharma GmbH
city: Strallegg
country: Austria
facility: Nycomed Pharma GmbH
city: Sulz
country: Austria
facility: Nycomed Pharma GmbH
city: Thalheim bei Wels
country: Austria
facility: Nycomed Pharma GmbH
city: Traisen
country: Austria
facility: Nycomed Pharma GmbH
city: Traismauer
country: Austria
facility: Nycomed Pharma GmbH
city: Voitsberg
country: Austria
facility: Nycomed Pharma GmbH
city: Waidhofen/Thaya
country: Austria
facility: Nycomed Pharma GmbH
city: Weitra
country: Austria
facility: Nycomed Pharma GmbH
city: Wiener Neustadt
country: Austria
facility: Nycomed Pharma GmbH
city: Wien
country: Austria
facility: Nycomed Pharma GmbH
city: Wien
country: Austria
facility: Nycomed Pharma GmbH
city: Wien
country: Austria
facility: Nycomed Pharma GmbH
city: Wien
country: Austria
facility: Nycomed Pharma GmbH
city: Wien
country: Austria
facility: Nycomed Pharma GmbH
city: Wien
country: Austria
facility: Nycomed Pharma GmbH
city: Wien
country: Austria
facility: Nycomed Pharma GmbH
city: Wien
country: Austria
facility: Nycomed Pharma GmbH
city: Wien
country: Austria
facility: Nycomed Pharma GmbH
city: Wilhelmsburg
country: Austria
facility: Nycomed Pharma GmbH
city: Wr. Neustadt
country: Austria
facility: Nycomed Pharma GmbH
city: Yspertal
country: Austria
facility: Nycomed Pharma GmbH
city: Zwettl
country: Austria
facility: Nycomed Pharma GmbH
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: