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CompletedNCT01147224ATEMUpdated Dec 5, 2016

ATEM (Alvesco Non-interventional Study)

An observational study in Asthma and Allergy, sponsored by AstraZeneca. Completed at 80 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-05.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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 .

02

Conditions studied

  • Asthma
  • Allergy

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Keywords

  • Asthma
  • Allergy
  • Ciclesonide
  • Alvesco
  • Inhaled steroids
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 400 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Outpatients

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)

Groups and cohorts

  • ATEM

    A prospective one-arm non-interventional study with asthma patients treated with Alvesco.

    Drug: Alvesco

Interventions

  • DrugAlvesco

    This is an observational study. Therefore, the physician decides about dosage according to individual needs.

    Also known as: Ciclesonide

06

What researchers measure

Primary outcomes

  1. Treatment success with Alvesco

    Pre-/ post comparison of FEV1, Quality of life, Patient Questionnaire

    Time frame: after 3 months

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: after 3 months

07

Study locations

80 sites
  • Nycomed Pharma GmbH
    Amstetten, 3300, Austria
  • Nycomed Pharma GmbH
    Baden, 2500, Austria
  • Nycomed Pharma GmbH
    Bludenz, 6700, Austria
  • Nycomed Pharma GmbH
    Braunau, 5280, Austria
  • Nycomed Pharma GmbH
    Bregenz, 6900, Austria
  • Nycomed Pharma GmbH
    Böhlerwerk, 3333, Austria
  • Nycomed Pharma GmbH
    Dornbirn, 6850, Austria
  • Nycomed Pharma GmbH
    Enns, 4470, Austria
  • Nycomed Pharma GmbH
    Feldbach, 8330, Austria
  • Nycomed Pharma GmbH
    Feldkirch, 6800, Austria
  • Nycomed Pharma GmbH
    Furth, 3511, Austria
  • Nycomed Pharma GmbH
    Gföhl, 3542, Austria
  • Nycomed Pharma GmbH
    Gr. Siegharts, 3812, Austria
  • Nycomed Pharma GmbH
    Graz-Gösting, 8051, Austria
  • Nycomed Pharma GmbH
    Graz, 8010, Austria
  • Nycomed Pharma GmbH
    Graz, 8020, Austria
  • Nycomed Pharma GmbH
    Graz, 8036, Austria
  • Nycomed Pharma GmbH
    Graz, 8042, Austria
  • Nycomed Pharma GmbH
    Groß Gerungs, 3920, Austria
  • Nycomed Pharma GmbH
    Gunskirchen, 4623, Austria
  • Nycomed Pharma GmbH
    Güssing, 7540, Austria
  • Nycomed Pharma GmbH
    Haag, 4680, Austria
  • Nycomed Pharma GmbH
    Hall in Tirol, 6060, Austria
  • Nycomed Pharma GmbH
    Hallein, 5400, Austria
  • Nycomed Pharma GmbH
    Hartberg, 8230, Austria
  • Nycomed Pharma GmbH
    Herzogenburg, 3130, Austria
  • Nycomed Pharma GmbH
    Innsbruck, 6020, Austria
  • Nycomed Pharma GmbH
    Judenburg, 8750, Austria
  • Nycomed Pharma GmbH
    Kaltenbach, 6272, Austria
  • Nycomed Pharma GmbH
    Kirchdorf and der Krems, 4560, Austria
  • Nycomed Pharma GmbH
    Kitzbühel, 6370, Austria
  • Nycomed Pharma GmbH
    Klein-Pöchlam, 3660, Austria
  • Nycomed Pharma GmbH
    Landeck, 6500, Austria
  • Nycomed Pharma GmbH
    Leibnitz, 8430, Austria
  • Nycomed Pharma GmbH
    Lenzing, 4860, Austria
  • Nycomed Pharma GmbH
    Linz, 4020, Austria
  • Nycomed Pharma GmbH
    Linz, 4030, Austria
  • Nycomed Pharma GmbH
    Linz, 4040, Austria
  • Nycomed Pharma GmbH
    Litschau, 3874, Austria
  • Nycomed Pharma GmbH
    Mank, 3240, Austria
  • Nycomed Pharma GmbH
    Melk, 3390, Austria
  • Nycomed Pharma GmbH
    Mittersill, 5730, Austria
  • Nycomed Pharma GmbH
    Munster, 6232, Austria
  • Nycomed Pharma GmbH
    Mödling, 2340, Austria
  • Nycomed Pharma GmbH
    Mühldorf, 3622, Austria
  • Nycomed Pharma GmbH
    Neumarkt, 7461, Austria
  • Nycomed Pharma GmbH
    Niederkreuzstetten, 2124, Austria
  • Nycomed Pharma GmbH
    Pasching, 4061, Austria
  • Nycomed Pharma GmbH
    Pinkafeld, 7423, Austria
  • Nycomed Pharma GmbH
    Pucking, 4055, Austria
  • Nycomed Pharma GmbH
    Salzburg, 5020, Austria
  • Nycomed Pharma GmbH
    Schlüßlberg, 4707, Austria
  • Nycomed Pharma GmbH
    Schwanenstadt, 4690, Austria
  • Nycomed Pharma GmbH
    Schörfling, 4861, Austria
  • Nycomed Pharma GmbH
    St. Johann i. Pg., 5600, Austria
  • Nycomed Pharma GmbH
    St. Pölten, 3100, Austria
  • Nycomed Pharma GmbH
    St.Georgen i.A., 4880, Austria
  • Nycomed Pharma GmbH
    Steyr, 4400, Austria
  • Nycomed Pharma GmbH
    Strallegg, 8192, Austria
  • Nycomed Pharma GmbH
    Sulz, 6832, Austria
  • Nycomed Pharma GmbH
    Thalheim bei Wels, 4600, Austria
  • Nycomed Pharma GmbH
    Traisen, 3160, Austria
  • Nycomed Pharma GmbH
    Traismauer, 3133, Austria
  • Nycomed Pharma GmbH
    Voitsberg, 8570, Austria
  • Nycomed Pharma GmbH
    Waidhofen/Thaya, 3830, Austria
  • Nycomed Pharma GmbH
    Weitra, 3970, Austria
  • Nycomed Pharma GmbH
    Wiener Neustadt, 2700, Austria
  • Nycomed Pharma GmbH
    Wien, 1010, Austria
  • Nycomed Pharma GmbH
    Wien, 1030, Austria
  • Nycomed Pharma GmbH
    Wien, 1080, Austria
  • Nycomed Pharma GmbH
    Wien, 1090, Austria
  • Nycomed Pharma GmbH
    Wien, 1100, Austria
  • Nycomed Pharma GmbH
    Wien, 1190, Austria
  • Nycomed Pharma GmbH
    Wien, 1210, Austria
  • Nycomed Pharma GmbH
    Wien, 1220, Austria
  • Nycomed Pharma GmbH
    Wien, 1230, Austria
  • Nycomed Pharma GmbH
    Wilhelmsburg, 3150, Austria
  • Nycomed Pharma GmbH
    Wr. Neustadt, 2700, Austria
  • Nycomed Pharma GmbH
    Yspertal, 3683, Austria
  • Nycomed Pharma GmbH
    Zwettl, 3910, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01147224
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jun 22, 2010
Start date
Mar 2010
Primary completion
May 2011
Completion
Aug 2011
Last update
Dec 5, 2016

Study contacts

AstraZeneca AstraZeneca
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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