AsthmaPEGASE2NCT03592212
Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma
An observational study of Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study is designed to investigate whether the Phosphodiesterase 4 gene variability could be implicated in the salbutamol responsiveness in asthmatic children. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Salbutamol
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2018to 14 Nov 2019
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children 6-18 years old asthmatic patients consulting in the Department of Pediatric Pulmonology and Allergy of Necker University Hospital.
Who may be able to join
- Children 6-18 years
- Asthma: confirmed asthma symptoms (wheeze, cough, dyspnea, chest tightness) and evidence for variable airflow limitation (≥ 12% increase in post bronchodilator FEV1, or ≥ 20% decrease in FEV1 post methacholine)
- Spirometry prescribed for follow-up
- Airflow limitation: FEV1<80% and/or FEV1/FVC <80 pre-bronchodilator
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to investigate whether the Phosphodiesterase 4 gene variability could be implicated in the salbutamol responsiveness in asthmatic children.
Read the detailed description
Patients from 6 to 18 years old with asthma and receiving a treatment by salbutamol according to the usual care will be recruited. Saliva from patients will be collected using Oragen®.DNA OG-575 kit.
- Conditions
- Asthma
- Being tested
- Salbutamol
- Keywords
- Asthma, Salbutamol response, Phosphodiesterase 4 variant, lung function, airflow limitation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
Measurement of bronchodilator response (BDR)
What is being measured
The primary outcome is the main question the study is designed to answer.
pre- and post-bronchodilator VEMS value
comparison of acute response to salbutamol calculated as the percentage difference between the pre- and post-bronchodilator VEMS value (BDR = 100 x [post-VEMS - pre-VEMS]/pre-VEMS) according to the genotype of the rs1504982
Measured: Day 0
Secondary outcomes (2)
Locating other regions of the PDE4 gene that may be associated with the response to salbutamol by gene mapping (using SNP tags)
To identify other SNPs on PDE4 associated with the response (BDR) to salbutamol in childhood asthma.
Measured: Day 0
Screening other SNPs (other genes than PDE4) associated with the response to salbutamol in childhood asthma using SNP tags
To identify other genes that could be associated with the phenotype of interest (BDR) by tagging other genes.
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 posted19 Jul 2018
- Study start23 Nov 2018
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Why it stopped: Number of inclusioNs not reached
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 Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Guillaume LEZMI, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592212
- Sponsor's protocol ID
- NI16014
- Acronym
- PEGASE2
- Status last verified
- Apr 2026
- First submitted
- 9 May 2018
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphodiesterase 4 Gene Variant and Salbutamol Response in Persistent Childhood Asthma
- ClinicalTrials.gov ID
- NCT03592212
- Acronym / sponsor ID
- PEGASE2 / NI16014
- Conditions
- Asthma
- Keywords
- Asthma, Salbutamol response, Phosphodiesterase 4 variant, lung function, airflow limitation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Number of inclusioNs not reached
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 19 Jul 2018 (actual)
- 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 investigate whether the Phosphodiesterase 4 gene variability could be implicated in the salbutamol responsiveness in asthmatic children.
Detailed description
Patients from 6 to 18 years old with asthma and receiving a treatment by salbutamol according to the usual care will be recruited. Saliva from patients will be collected using Oragen®.DNA OG-575 kit.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children 6-18 years old asthmatic patients consulting in the Department of Pediatric Pulmonology and Allergy of Necker University Hospital.
Key inclusion criteria (4 listed)
- Children 6-18 years
- Asthma: confirmed asthma symptoms (wheeze, cough, dyspnea, chest tightness) and evidence for variable airflow limitation (≥ 12% increase in post bronchodilator FEV1, or ≥ 20% decrease in FEV1 post methacholine)
- Spirometry prescribed for follow-up
- Airflow limitation: FEV1<80% and/or FEV1/FVC <80 pre-bronchodilator
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| SalbutamolMeasurement of bronchodilator response (BDR) | Drug | – |
Primary outcome
pre- and post-bronchodilator VEMS value
Time frame: Day 0
comparison of acute response to salbutamol calculated as the percentage difference between the pre- and post-bronchodilator VEMS value (BDR = 100 x [post-VEMS - pre-VEMS]/pre-VEMS) according to the genotype of the rs1504982
2 secondary outcomes
Locating other regions of the PDE4 gene that may be associated with the response to salbutamol by gene mapping (using SNP tags)
Time frame: Day 0
Screening other SNPs (other genes than PDE4) associated with the response to salbutamol in childhood asthma using SNP tags
Time frame: Day 0
Results and safety
The study was stopped early (reason given: Number of inclusioNs not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- 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.
Guillaume LEZMI, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 May 2026. 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 was stopped early (reason given: Number of inclusioNs not reached). Results are not available in the source record.
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 VEMS value (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 6 May 2026.