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Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis (SALBUTAMOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02877537
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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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.


Condition or disease Intervention/treatment Phase
Asthma Drug: Salbutamol Procedure: Forced oscillation technique Procedure: Plethysmography Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Measurements of Change of Respiratory Admittance Induced by Salbutamol for Pediatric Asthma Diagnosis
Study Start Date : October 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Asthma child Drug: Salbutamol
bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber
Other Name: 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 Name: 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 Name: Ventoline

Procedure: Forced oscillation technique
before and after bronchodilation

Procedure: Plethysmography


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Thoracic gas volume [ Time Frame: day 0 ]
    Measured with Plethysmography.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877537


Locations
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France
CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques
Vandœuvre-lès-Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: François MARCHAL CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques
More Information
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02877537    
Other Study ID Numbers: 2007-002822-31
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action