ATEM (Alvesco Non-interventional Study) (ATEM)

December 2, 2016 updated by: AstraZeneca

Alvesco for the Therapy of Persistent Asthma With or Without Allergic Component

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Amstetten, Austria, 3300
        • Nycomed Pharma GmbH
      • Baden, Austria, 2500
        • Nycomed Pharma GmbH
      • Bludenz, Austria, 6700
        • Nycomed Pharma GmbH
      • Braunau, Austria, 5280
        • Nycomed Pharma GmbH
      • Bregenz, Austria, 6900
        • Nycomed Pharma GmbH
      • Böhlerwerk, Austria, 3333
        • Nycomed Pharma GmbH
      • Dornbirn, Austria, 6850
        • Nycomed Pharma GmbH
      • Enns, Austria, 4470
        • Nycomed Pharma GmbH
      • Feldbach, Austria, 8330
        • Nycomed Pharma GmbH
      • Feldkirch, Austria, 6800
        • Nycomed Pharma GmbH
      • Furth, Austria, 3511
        • Nycomed Pharma GmbH
      • Gföhl, Austria, 3542
        • Nycomed Pharma GmbH
      • Gr. Siegharts, Austria, 3812
        • Nycomed Pharma GmbH
      • Graz, Austria, 8010
        • Nycomed Pharma GmbH
      • Graz, Austria, 8020
        • Nycomed Pharma GmbH
      • Graz, Austria, 8036
        • Nycomed Pharma GmbH
      • Graz, Austria, 8042
        • Nycomed Pharma GmbH
      • Graz-Gösting, Austria, 8051
        • Nycomed Pharma GmbH
      • Groß Gerungs, Austria, 3920
        • Nycomed Pharma GmbH
      • Gunskirchen, Austria, 4623
        • Nycomed Pharma GmbH
      • Güssing, Austria, 7540
        • Nycomed Pharma GmbH
      • Haag, Austria, 4680
        • Nycomed Pharma GmbH
      • Hall in Tirol, Austria, 6060
        • Nycomed Pharma GmbH
      • Hallein, Austria, 5400
        • Nycomed Pharma GmbH
      • Hartberg, Austria, 8230
        • Nycomed Pharma GmbH
      • Herzogenburg, Austria, 3130
        • Nycomed Pharma GmbH
      • Innsbruck, Austria, 6020
        • Nycomed Pharma GmbH
      • Judenburg, Austria, 8750
        • Nycomed Pharma GmbH
      • Kaltenbach, Austria, 6272
        • Nycomed Pharma GmbH
      • Kirchdorf and der Krems, Austria, 4560
        • Nycomed Pharma GmbH
      • Kitzbühel, Austria, 6370
        • Nycomed Pharma GmbH
      • Klein-Pöchlam, Austria, 3660
        • Nycomed Pharma GmbH
      • Landeck, Austria, 6500
        • Nycomed Pharma GmbH
      • Leibnitz, Austria, 8430
        • Nycomed Pharma GmbH
      • Lenzing, Austria, 4860
        • Nycomed Pharma GmbH
      • Linz, Austria, 4020
        • Nycomed Pharma GmbH
      • Linz, Austria, 4030
        • Nycomed Pharma GmbH
      • Linz, Austria, 4040
        • Nycomed Pharma GmbH
      • Litschau, Austria, 3874
        • Nycomed Pharma GmbH
      • Mank, Austria, 3240
        • Nycomed Pharma GmbH
      • Melk, Austria, 3390
        • Nycomed Pharma GmbH
      • Mittersill, Austria, 5730
        • Nycomed Pharma GmbH
      • Munster, Austria, 6232
        • Nycomed Pharma GmbH
      • Mödling, Austria, 2340
        • Nycomed Pharma GmbH
      • Mühldorf, Austria, 3622
        • Nycomed Pharma GmbH
      • Neumarkt, Austria, 7461
        • Nycomed Pharma GmbH
      • Niederkreuzstetten, Austria, 2124
        • Nycomed Pharma GmbH
      • Pasching, Austria, 4061
        • Nycomed Pharma GmbH
      • Pinkafeld, Austria, 7423
        • Nycomed Pharma GmbH
      • Pucking, Austria, 4055
        • Nycomed Pharma GmbH
      • Salzburg, Austria, 5020
        • Nycomed Pharma GmbH
      • Schlüßlberg, Austria, 4707
        • Nycomed Pharma GmbH
      • Schwanenstadt, Austria, 4690
        • Nycomed Pharma GmbH
      • Schörfling, Austria, 4861
        • Nycomed Pharma GmbH
      • St. Johann i. Pg., Austria, 5600
        • Nycomed Pharma GmbH
      • St. Pölten, Austria, 3100
        • Nycomed Pharma GmbH
      • St.Georgen i.A., Austria, 4880
        • Nycomed Pharma GmbH
      • Steyr, Austria, 4400
        • Nycomed Pharma GmbH
      • Strallegg, Austria, 8192
        • Nycomed Pharma GmbH
      • Sulz, Austria, 6832
        • Nycomed Pharma GmbH
      • Thalheim bei Wels, Austria, 4600
        • Nycomed Pharma GmbH
      • Traisen, Austria, 3160
        • Nycomed Pharma GmbH
      • Traismauer, Austria, 3133
        • Nycomed Pharma GmbH
      • Voitsberg, Austria, 8570
        • Nycomed Pharma GmbH
      • Waidhofen/Thaya, Austria, 3830
        • Nycomed Pharma GmbH
      • Weitra, Austria, 3970
        • Nycomed Pharma GmbH
      • Wien, Austria, 1010
        • Nycomed Pharma GmbH
      • Wien, Austria, 1030
        • Nycomed Pharma GmbH
      • Wien, Austria, 1080
        • Nycomed Pharma GmbH
      • Wien, Austria, 1090
        • Nycomed Pharma GmbH
      • Wien, Austria, 1100
        • Nycomed Pharma GmbH
      • Wien, Austria, 1190
        • Nycomed Pharma GmbH
      • Wien, Austria, 1210
        • Nycomed Pharma GmbH
      • Wien, Austria, 1220
        • Nycomed Pharma GmbH
      • Wien, Austria, 1230
        • Nycomed Pharma GmbH
      • Wiener Neustadt, Austria, 2700
        • Nycomed Pharma GmbH
      • Wilhelmsburg, Austria, 3150
        • Nycomed Pharma GmbH
      • Wr. Neustadt, Austria, 2700
        • Nycomed Pharma GmbH
      • Yspertal, Austria, 3683
        • Nycomed Pharma GmbH
      • Zwettl, Austria, 3910
        • Nycomed Pharma GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Outpatients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ATEM
A prospective one-arm non-interventional study with asthma patients treated with Alvesco.
Drug: Alvesco
This is an observational study. Therefore, the physician decides about dosage according to individual needs.
Other Names:
  • Ciclesonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success with Alvesco
Time Frame: after 3 months
Pre-/ post comparison of FEV1, Quality of life, Patient Questionnaire
after 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: after 3 months
after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

June 17, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-9709-401-DE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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