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
| Tracking Information | |||||
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| First Received Date ICMJE | June 17, 2010 | ||||
| Last Updated Date | May 4, 2012 | ||||
| Start Date ICMJE | March 2010 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Treatment success with Alvesco [ Time Frame: after 3 months ] [ Designated as safety issue: No ] Pre-/ post comparison of FEV1, Quality of life, Patient Questionnaire |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01147224 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: after 3 months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Tolerability [ Time Frame: after 3 months ] [ Designated as safety issue: Yes ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | ATEM (Alvesco Non-interventional Study) | ||||
| Official Title ICMJE | Alvesco for the Therapy of Persistent Asthma With or Without Allergic Component | ||||
| 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 . |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Outpatients |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Alvesco
This is an observational study. Therefore, the physician decides about dosage according to individual needs.
Other Name: Ciclesonide |
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| Study Group/Cohort (s) | ATEM
A prospective one-arm non-interventional study with asthma patients treated with Alvesco.
Intervention: Drug: Alvesco |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Completion Date | August 2011 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Main Inclusion Criteria:
Main Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01147224 | ||||
| Other Study ID Numbers ICMJE | CL-9709-401-DE | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Ingrid Moll-Schüler, Nycomed Pharma GmbH | ||||
| Study Sponsor ICMJE | Nycomed: A Takeda Company | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nycomed: A Takeda Company | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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