Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis (SALBUTAMOL)

August 19, 2016 updated by: Central Hospital, Nancy, France

Measurements of Change of Respiratory Admittance Induced by Salbutamol for Pediatric Asthma Diagnosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France
        • CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Asthma child
Drug: Salbutamol
bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber
Other Names:
  • Ventoline
Procedure: Forced oscillation technique
before and after bronchodilation
Procedure: Plethysmography
EXPERIMENTAL: Control adult
Drug: Salbutamol
bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber
Other Names:
  • Ventoline
Procedure: Forced oscillation technique
before and after bronchodilation
Procedure: Plethysmography
EXPERIMENTAL: Control child
Drug: Salbutamol
bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber
Other Names:
  • Ventoline
Procedure: Forced oscillation technique
before and after bronchodilation
Procedure: Plethysmography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilatory mechanical impedance
Time Frame: day 0
Measured with Forced oscillation technique. 2 measures at basal status at 10 min interval for reproducibility and after 10 min broncodilation with salbutamol
day 0
Thoracic gas volume
Time Frame: day 0
Measured with Plethysmography.
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: François MARCHAL, CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (ESTIMATE)

August 24, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-002822-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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