- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02877537
Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis (SALBUTAMOL)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Vandœuvre-lès-Nancy, France
- CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber
Other Names:
before and after bronchodilation
|
EXPERIMENTAL: Control adult
|
bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber
Other Names:
before and after bronchodilation
|
EXPERIMENTAL: Control child
|
bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber
Other Names:
before and after bronchodilation
|
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
Sponsor
Investigators
- Principal Investigator: François MARCHAL, CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
Other Study ID Numbers
- 2007-002822-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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