Prevalence and Reversibility of Lung Hyperinflation in Asthma

Asthma Clinical Trial

— Dist'air2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573364
• Other study ID #: EQFST5213
• Status: Completed
• Phase: N/A
• First received: April 5, 2012
• Last updated: April 5, 2012
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
France	Laboratoire Chiesi S.A.	Courbevoie

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

France,