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ATEM (Alvesco Non-interventional Study)

This study has been completed.
Sponsor:
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
History of Changes
  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:

MedlinePlus related topics: Allergy Asthma
Drug Information available for: Ciclesonide
U.S. FDA Resources

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

  Show 80 Study Locations
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 May 22, 2013