AsthmaPegaseNCT02195258
Pharmacogenetic of Salbutamol in Pediatric Asthma Crisis
An observational study of Asthma, run by Hôpital Necker-Enfants Malades at 1 site in France.
Trial summary
this study is designed to identify the genetic factors which can be implicated in the salbutamol responsiveness for asthmatic children in pediatric emergency department Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Asthma
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Jun 2013
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: children 6-16 years old asthmatic patients consulting for an exacerbation in a pediatric emergency department
Who may be able to join
- children
- 6-16 years old
- asthmatic patients
- consulting for an exacerbation in a pediatric emergency department
- parental informed consent
Who cannot join
- comorbidity
- peak flow no available
- pneumonia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacogenetic of the Salbutamol Efficacy in Asthma Crisis for Children in Emergency Department
this study is designed to identify the genetic factors which can be implicated in the salbutamol responsiveness for asthmatic children in pediatric emergency department
Read the detailed description
Patients from 6 to 16 years old consulting for an acute asthma exacerbation and receiving a treatment by salbutamol according to the usual care could be recruited.Saliva from patient were collected using Oragen®.DNA OG-500 kit or swabs.Based on literature review, four SNP were chosen:ADBR2 gene), ARG gene, and GSNOR gene.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| salbutamol | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1)
comparison of acute response to salbutamol calculated as the percentage difference between the pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1) between the different polymorphism
Measured: Day 0
Secondary outcomes (1)
polymorphism on the response delay
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 posted21 Jul 2014 (estimated)
- Study startNov 2010
- Primary completionMay 2012
- Study completionJun 2013
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hôpital Necker-Enfants Malades
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Chappuy, Hôpital Necker-Enfants Malades
- Investigators
- Hélène Chappuy, MDPhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195258
- Sponsor's protocol ID
- URC Paris centre
- Acronym
- Pegase
- Status last verified
- Jul 2013
- First submitted
- 4 Jul 2013
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic of the Salbutamol Efficacy in Asthma Crisis for Children in Emergency Department
- ClinicalTrials.gov ID
- NCT02195258
- Acronym / sponsor ID
- Pegase / URC Paris centre
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hôpital Necker-Enfants MaladesUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Jul 2014 (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.
this study is designed to identify the genetic factors which can be implicated in the salbutamol responsiveness for asthmatic children in pediatric emergency department
Detailed description
Patients from 6 to 16 years old consulting for an acute asthma exacerbation and receiving a treatment by salbutamol according to the usual care could be recruited.Saliva from patient were collected using Oragen®.DNA OG-500 kit or swabs.Based on literature review, four SNP were chosen:ADBR2 gene), ARG gene, and GSNOR gene.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| salbutamol | – | – |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children 6-16 years old asthmatic patients consulting for an exacerbation in a pediatric emergency department
Key inclusion criteria (5 listed)
- children
- 6-16 years old
- asthmatic patients
- consulting for an exacerbation in a pediatric emergency department
- parental informed consent
Key exclusion criteria (3 listed)
- comorbidity
- peak flow no available
- pneumonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1)
Time frame: Day 0
comparison of acute response to salbutamol calculated as the percentage difference between the pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1) between the different polymorphism
1 secondary outcome
polymorphism on the response delay
Time frame: Day 0
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 21 Jul 2014.
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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.
Hélène Chappuy, MDPhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Hôpital Necker-Enfants Malades 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 5 inclusion and 3 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 21 Jul 2014. 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.
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?
pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1) (time frame: Day 0). 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 21 Jul 2014.