Prevalence and Reversibility of Lung Hyperinflation in Asthma

NCT ID: NCT01573364

Last Updated: 2012-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Capucine de Meynard, MD

Role: STUDY_DIRECTOR

Chiesi S.A.

Daniel Dusser, MD, Prof

Role: STUDY_CHAIR

Hopital Cochin Paris France

Locations

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Laboratoire Chiesi S.A.

Courbevoie, , France

Site Status

Countries

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France

References

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Perez T, Chanez P, Dusser D, Devillier P. Prevalence and reversibility of lung hyperinflation in adult asthmatics with poorly controlled disease or significant dyspnea. Allergy. 2016 Jan;71(1):108-14. doi: 10.1111/all.12789. Epub 2015 Nov 6.

Reference Type DERIVED
PMID: 26466328 (View on PubMed)

Other Identifiers

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EQFST5213

Identifier Type: -

Identifier Source: org_study_id

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