Prevalence and Reversibility of Lung Hyperinflation in Asthma (Dist'air2)

April 5, 2012 updated by: Chiesi Farmaceutici S.p.A.

Evaluation of the Prevalence and the Reversibility of the Lung Hyperinflation in Uncontrolled Persistent Asthmatic Patients With Dyspnea

The aim of this observational study is to evaluate the pulmonary hyperinflation and its immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent asthmatic patients with dyspnea.

Study Overview

Status

Completed

Conditions

Detailed Description

The other objectives are :

  • the evaluation of the hyperinflation defined by an increase of the residual volume (RV),
  • the observation of the relationship between the hyperinflation and the asthma characteristics,
  • the study of the improvement of the functional parameters after a reversibility test
  • the evaluation of the correlation between hyperinflation parameters evolution, chest tightness and dyspnea

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Courbevoie, France
        • Laboratoire Chiesi S.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults

Description

Inclusion Criteria:

  • Patient with a diagnosis of uncontrolled persistent asthma (ACT </= 19) or with an MRC score of dyspnea >/= 1
  • Patient requiring a check-up including a pulmonary function test by plethysmography with a reversibility test

Exclusion Criteria:

  • Patient participating to an other clinical trial or having participated to a clinical trial with medicine in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Study Director: Capucine de Meynard, MD, Chiesi S.A.
  • Study Chair: Daniel Dusser, MD, Prof, Hopital Cochin Paris FRance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimate)

April 9, 2012

Study Record Updates

Last Update Posted (Estimate)

April 9, 2012

Last Update Submitted That Met QC Criteria

April 5, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EQFST5213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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