ATEM (Alvesco Non-interventional Study)

Completed

• Conditions: Asthma; Allergy
• Interventions: Drug: Alvesco

• Registration Number: NCT01147224
• Lead Sponsor: AstraZeneca

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Primary Completion: 2011-05
• Study Completion: 2011-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ATEM	Alvesco	A prospective one-arm non-interventional study with asthma patients treated with Alvesco.

Primary Outcome Measures

Name	Time	Method
Treatment success with Alvesco	after 3 months	Pre-/ post comparison of FEV1, Quality of life, Patient Questionnaire

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	after 3 months

Trial Locations

Locations (1)

Nycomed Pharma GmbH; 🇦🇹 Zwettl, Austria