Prevalence and Reversibility of Lung Hyperinflation in As... | NCT01573364

Studies
Prevalence and Reversibility of Lung Hyperinflation in Asthma

NCT01573364

Sponsor

Chiesi Farmaceutici S.p.A.

Status

Completed

Last Update Posted

Apr 9, 2012Estimated

Enrollment

450Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Apr 5, 2012

First Submission Date that Met QC Criteria

Apr 5, 2012

First Posted Date

Apr 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2012

Last Update Posted Date

Apr 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Actual

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Capucine de Meynard, MD	Chiesi S.A.	Study Director
Daniel Dusser, MD, Prof	Hopital Cochin Paris France	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratoire Chiesi S.A.		Courbevoie			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26466328	Derived	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.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases