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Completed

NCT Number: NCT01147224

ATEM (Alvesco Non-interventional Study)

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed Pharma GmbH, Amstetten, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alvesco

Drug

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

Other names: Ciclesonide

Primary outcomes

  1. Treatment success with Alvesco

    Time frame: after 3 months

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

Secondary outcomes

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

    Time frame: after 3 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ATEM

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2010
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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