ATEM (Alvesco Non-interventional Study)
This study has been completed.
Sponsor:
Nycomed: A Takeda Company
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT01147224
First received: June 17, 2010
Last updated: May 4, 2012
Last verified: May 2012
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Purpose
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 .
| Condition | Intervention |
|---|---|
|
Asthma Allergy |
Drug: Alvesco |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Alvesco for the Therapy of Persistent Asthma With or Without Allergic Component |
Resource links provided by NLM:
Further study details as provided by Nycomed: A Takeda Company:
Primary Outcome Measures:
- Treatment success with Alvesco [ Time Frame: after 3 months ] [ Designated as safety issue: No ]Pre-/ post comparison of FEV1, Quality of life, Patient Questionnaire
Secondary Outcome Measures:
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: after 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2010 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 Name: Ciclesonide
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Outpatients
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147224
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Hide Study LocationsLocations
| Austria | |
| Nycomed Pharma GmbH | |
| 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, 8036 | |
| Nycomed Pharma GmbH | |
| Graz, Austria, 8042 | |
| Nycomed Pharma GmbH | |
| Graz, Austria, 8020 | |
| 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, 4030 | |
| Nycomed Pharma GmbH | |
| Linz, Austria, 4040 | |
| Nycomed Pharma GmbH | |
| Linz, Austria, 4020 | |
| 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, 1030 | |
| Nycomed Pharma GmbH | |
| Wien, Austria, 1080 | |
| Nycomed Pharma GmbH | |
| Wien, Austria, 1190 | |
| Nycomed Pharma GmbH | |
| Wien, Austria, 1010 | |
| Nycomed Pharma GmbH | |
| Wien, Austria, 1220 | |
| Nycomed Pharma GmbH | |
| Wien, Austria, 1210 | |
| Nycomed Pharma GmbH | |
| Wien, Austria, 1100 | |
| Nycomed Pharma GmbH | |
| Wien, Austria, 1090 | |
| 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 | |
Sponsors and Collaborators
Nycomed: A Takeda Company
Investigators
| Study Director: | Ingrid Moll-Schüler, MD | Nycomed Pharma GmbH |
More Information
No publications provided
| Responsible Party: | Dr. Ingrid Moll-Schüler, Nycomed Pharma GmbH |
| ClinicalTrials.gov Identifier: | NCT01147224 History of Changes |
| Other Study ID Numbers: | CL-9709-401-DE |
| Study First Received: | June 17, 2010 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Nycomed: A Takeda Company:
|
Asthma Allergy Ciclesonide Alvesco Inhaled steroids |
Additional relevant MeSH terms:
|
Hypersensitivity Asthma Immune System Diseases Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Ciclesonide Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013