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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01573364
First received: April 5, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Prevalence and the Reversibility of the Lung Hyperinflation in Uncontrolled Persistent Asthmatic Patients With Dyspnea

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Enrollment: 450
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573364

Locations
France
Laboratoire Chiesi S.A.
Courbevoie, France
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01573364     History of Changes
Other Study ID Numbers: EQFST5213
Study First Received: April 5, 2012
Last Updated: April 5, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority

Keywords provided by Chiesi Farmaceutici S.p.A.:
Distal Airways
Hyperinflation
Reversibility

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014