NCT02877537

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

3.5 years

First QC Date

August 19, 2016

Last Update Submit

August 19, 2016

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

  • 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

    day 0

  • Thoracic gas volume

    Measured with Plethysmography.

    day 0

Study Arms (3)

Asthma child

EXPERIMENTAL
Drug: SalbutamolProcedure: Forced oscillation techniqueProcedure: Plethysmography

Control adult

EXPERIMENTAL
Drug: SalbutamolProcedure: Forced oscillation techniqueProcedure: Plethysmography

Control child

EXPERIMENTAL
Drug: SalbutamolProcedure: Forced oscillation techniqueProcedure: Plethysmography

Interventions

SalbutamolDRUG

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

Also known as: Ventoline
Asthma childControl adultControl child
Forced oscillation techniquePROCEDURE

before and after bronchodilation

Asthma childControl adultControl child
PlethysmographyPROCEDURE
Asthma childControl adultControl child

Eligibility Criteria

Age3 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • François MARCHAL

    CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 24, 2016

Study Start

October 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 24, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)