Clinical trial NCT00608218: Efficacy of Ciclesonide During the Cold Season in Patients Older Than 12 Years With Persistent Asthma
Official title: Ciclesonide for the Therapy of Asthma During the Cold Season.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
ciclesonide
inhaled steroids
Alvesco
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 2100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: FEV1, symptom score assessment
timeFrame: within 3 months
Secondary outcomes:
measure: Handling of the metered-dose inhaler, safety and tolerability
timeFrame: within 3 months
Other outcomes:
Locations:
city: Adendorf
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Arnstadt
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Auerbach
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Augsburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Backnang
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bad Bramstedt
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bad Kreuznach
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bad Lippspringe
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bad Neuenahr-Ahrweiler
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bad Neustadt
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bad Soden
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bad Tölz
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bautzen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bergisch Gladbach
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Berlin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bietigheim-Bissingen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Braunschweig
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Braunschweig
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bredstedt
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Breisach
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bremen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bremen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bremerhaven
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bremerhaven
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bruchsal
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Bröckel
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Burgwedel
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Castrop-Rauxel
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Coburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Cottbus
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Delitzsch
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Dortmund
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Dortmund
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Dresden
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Dresden
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Duisburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Düren
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Düsseldorf
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Eisenach
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Erfurt
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Eschwege
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Finsterwalde
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Flensburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Frankfurt
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Freising
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Friedrichshafen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Fürstenwalde
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Garmisch-Partenkirchen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Gelsenkirchen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Gotha
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Greiz
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Hagen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Halle
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Halle
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Hamburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Hamburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Hamburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Hannover
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Hartha
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Haßloch
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Heidelberg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Heilbronn
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Herne
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Herten
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Hoyerswerda
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Husum
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Höchstadt
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Jettingen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Karlsruhe
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Kiel
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Kiel
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Koblenz
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Konstanz
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Köln
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Köln
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Laatzen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Leipzig
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Leipzig
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Leipzig
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Leipzig
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Limburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Lohfelden
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Mainz
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Mainz
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Mannheim
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Mannheim
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Marburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Markkleeberg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Menden
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Minden
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Moers
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Mühlhausen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: München
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Neu Wulmstorf
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Neubrandenburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Neumarkt
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Neuruppin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Neuss
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Nordhausen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Oberursel
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Offenburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Osnabrück
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Plauen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Radebeul
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Rendsburg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Rosengarten
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Rostock
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Saalfeld
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Saarbrücken
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Saarlouis
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Salzgitter
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Schmölln
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Schwalmtal
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Schwarmstedt
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Schwerin
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Siegen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Sinsheim
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Solingen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Sonneberg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Stadthagen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Starnberg
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Steißlingen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Straelen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Stuttgart
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Stuttgart
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Stuttgart
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Teterow
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Teuchern
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Uelzen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Ulm
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Umkirch
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Villingen-Schwenningen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Vilshofen
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Wallertheim
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Wilhelmshaven
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Witten
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Wörrstadt
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Wörth
country: Germany
facility: "Nycomed Deutschland GmbH"
city: Würzburg
country: Germany
facility: "Nycomed Deutschland GmbH"
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: