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Clinical Trials/NCT01147224
NCT01147224CompletedNot Applicable

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

AstraZeneca1 site in 1 country400 target enrollmentStarted: March 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
400
Locations
1
Primary Endpoint
Treatment success with Alvesco

Study Overview

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 .

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Asthma with or without allergic components

Exclusion Criteria

  • Hypersensitive to compounds of Alvesco
  • Other criteria as defined in the Summary of Product Characteristics, Chapter 4.3

Arms & Interventions

ATEM

A prospective one-arm non-interventional study with asthma patients treated with Alvesco.

Intervention: Alvesco (Drug)

Outcomes

Primary Outcomes

Treatment success with Alvesco

Time Frame: after 3 months

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

Secondary Outcomes

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability(after 3 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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