Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis

NCT ID: NCT02877537

Last Updated: 2016-08-24

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

Clinical Phase

PHASE4

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose is to characterize the change of respiratory admittance induced by salbutamol inhalation in children and young adults. A variation threshold will be fixed to distinguish asthmatic and healthy subjects.

This project could allow a better identification of asthmatic individuals needing a treatment, a reduction of morbidity of asthma, a reduction of unnecessary treatments administered in individuals with respiratory but not asthmatic symptoms, a better comprehension of bronchial hyperreactivity and its role in asthmatic disease.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Asthma child

Group Type EXPERIMENTAL

Salbutamol

Intervention Type DRUG

bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber

Forced oscillation technique

Intervention Type PROCEDURE

before and after bronchodilation

Plethysmography

Intervention Type PROCEDURE

Control adult

Group Type EXPERIMENTAL

Salbutamol

Intervention Type DRUG

bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber

Forced oscillation technique

Intervention Type PROCEDURE

before and after bronchodilation

Plethysmography

Intervention Type PROCEDURE

Control child

Group Type EXPERIMENTAL

Salbutamol

Intervention Type DRUG

bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber

Forced oscillation technique

Intervention Type PROCEDURE

before and after bronchodilation

Plethysmography

Intervention Type PROCEDURE

Interventions

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Salbutamol

bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber

Intervention Type DRUG

Forced oscillation technique

before and after bronchodilation

Intervention Type PROCEDURE

Plethysmography

Intervention Type PROCEDURE

Other Intervention Names

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Ventoline

Eligibility Criteria

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Inclusion Criteria

Asthmatic children group:

* Several episodes of paroxysmal wheezes, spontaneous or after exercise, without bronchial-pulmonary infection
* Absence of bronchodilator taking during last 12 hours
* Absence of reported intolerance to adrenergic substances
* Parental authorization and consent of child to participate to the study

Control children group:

\- Parental authorization and consent of child to participate to the study

Control adult group:

\- Consent to participate to the study

Exclusion Criteria

Control children and adult groups:

* At least 2 episodes of wheezes during breathing
* Several wheezes, abnormal breathlessness, cough during physical exercise
* Asthma diagnosed by family doctor
* Administration of drugs to treat asthma
* Eczema or food allergy at inclusion
* Episode of cough for longer than 6 weeks, without bronchial infection
* Bronchitis, throat infection, rhino-pharyngitis during last 15 days
* Paleness or cyanosis with loss of consciousness when the child was a baby or during an exercise
Minimum Eligible Age

3 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François MARCHAL

Role: PRINCIPAL_INVESTIGATOR

CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques

Locations

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CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2007-002822-31

Identifier Type: -

Identifier Source: org_study_id

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