AsthmaPhase 4SALBUTAMOLNCT02877537
Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis
A Phase 4 study testing Salbutamol, Forced oscillation technique and Plethysmography in people with Asthma, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Salbutamol, Forced oscillation technique and Plethysmography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Apr 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
Show all 9Show fewer
- Parental authorization and consent of child to participate to the study
- Control adult group:
- Consent to participate to the study
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques
Vandœuvre-lès-Nancy
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- Salbutamol, Forced oscillation technique, Plethysmography
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
Also called Ventoline
bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber
Forced oscillation techniqueProcedure or surgery
before and after bronchodilation
PlethysmographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Asthma child | Experimental | Not described Receives: Drug: Salbutamol; Procedure: Forced oscillation technique; Procedure: Plethysmography |
| Control adult | Experimental | Not described Receives: Drug: Salbutamol; Procedure: Forced oscillation technique; Procedure: Plethysmography |
| Control child | Experimental | Not described Receives: Drug: Salbutamol; Procedure: Forced oscillation technique; Procedure: Plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 0
Thoracic gas volume
Measured with Plethysmography.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startOct 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François MARCHAL, Principal investigator, CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877537
- Sponsor's protocol ID
- 2007-002822-31
- Acronym
- SALBUTAMOL
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Change of Respiratory Admittance Induced by Salbutamol for Pediatric Asthma Diagnosis
- ClinicalTrials.gov ID
- NCT02877537
- Acronym / sponsor ID
- SALBUTAMOL / 2007-002822-31
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma child | Experimental | Drug: Salbutamol, Procedure: Forced oscillation technique, Procedure: Plethysmography |
| Control adult | Experimental | Drug: Salbutamol, Procedure: Forced oscillation technique, Procedure: Plethysmography |
| Control child | Experimental | Drug: Salbutamol, Procedure: Forced oscillation technique, Procedure: Plethysmography |
Who may qualify
- Ages
- 3 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
- Parental authorization and consent of child to participate to the study
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalbutamolAlso: Ventolinebronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber | Drug | Asthma child, Control adult, Control child |
| Forced oscillation techniquebefore and after bronchodilation | Procedure or surgery | Asthma child, Control adult, Control child |
| Plethysmography | Procedure or surgery | Asthma child, Control adult, Control child |
Primary outcome
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
Thoracic gas volume
Time frame: day 0
Measured with Plethysmography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François MARCHAL principal investigator
CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salbutamol, Forced oscillation technique and Plethysmography in people with Asthma, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory mechanical impedance (time frame: day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.