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Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis (SALBUTAMOL)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Salbutamol
Forced oscillation technique
Plethysmography
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma

Eligibility Criteria

3 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Asthma child

Control adult

Control child

Arm Description

Outcomes

Primary Outcome Measures

Ventilatory mechanical impedance
Measured with Forced oscillation technique. 2 measures at basal status at 10 min interval for reproducibility and after 10 min broncodilation with salbutamol
Thoracic gas volume
Measured with Plethysmography.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2016
Last Updated
August 19, 2016
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02877537
Brief Title
Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis
Acronym
SALBUTAMOL
Official Title
Measurements of Change of Respiratory Admittance Induced by Salbutamol for Pediatric Asthma Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthma child
Arm Type
Experimental
Arm Title
Control adult
Arm Type
Experimental
Arm Title
Control child
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Other Intervention Name(s)
Ventoline
Intervention Description
bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber
Intervention Type
Procedure
Intervention Name(s)
Forced oscillation technique
Intervention Description
before and after bronchodilation
Intervention Type
Procedure
Intervention Name(s)
Plethysmography
Primary Outcome Measure Information:
Title
Ventilatory mechanical impedance
Description
Measured with Forced oscillation technique. 2 measures at basal status at 10 min interval for reproducibility and after 10 min broncodilation with salbutamol
Time Frame
day 0
Title
Thoracic gas volume
Description
Measured with Plethysmography.
Time Frame
day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François MARCHAL
Organizational Affiliation
CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques
City
Vandœuvre-lès-Nancy
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis

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