AsthmaPhase 2DORESINCT01470755
Study of Dose-response to Bronchodilator and Dose-finding in Child 2.5 to 6 Years - Study Golden
A Phase 2 study testing salbutamol, Salbutamol - dose2 and Salbutamol -dose3 in people with Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In older children and adults, bronchodilator (BD) dose-effect relationship is part of the characteristics of asthma disease. There are no data on BD dose-response relationship in wheezy preschool children whose disease pathophysiology is poorly understood, but may, in part, takes on the characteristics of asthma. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Asthma
- What is being tested?
- salbutamol, Salbutamol - dose2 and Salbutamol -dose3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jan 2014
- Phase
- Phase 2
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any patient between 2 years 6 months and 6 years 11 months of age referred for pulmonary function testing with bronchodilator test, due to recurrent wheezing ,at least three times in the past year, to LFT laboratories at Armand Trousseau, Robert Debré, both in Paris and Arnaud de VILLENEUVE, in Montpellier hospitals
- No use of bronchodilator in the previous 12 hours before the test
- Parents gave their signed consent for the study
Who cannot join
- Any patient aged 2 years 6 months and 6 years 11 months :
- with another chronic lung disease (bronchopulmonary dysplasia, chronic bronchitis, viral sequel, pathology of inhalation, thoracic-pulmonary malformation, tracheomalacia), anatomical or functional abnormality of the pharyngolaryngeal tract (tonsils touching or in contact with the uvula, laryngomalacia, subglottic stenosis, vocal cord paralysis, laryngeal obstruction)
- taking regular treatment including leukotrienes receptor antagonist during the week before the test.
- treated with oral glucocorticosteroids within 15 days before the test.
- without social security insurance
- with opposition of the family
- known intolerant to Salbutamol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Dose-response to Bronchodilator Then Bronchodilator Dose-finding Using the Flow Interruption Technique in Children Aged 2.5 TO 6 Years
In older children and adults, bronchodilator (BD) dose-effect relationship is part of the characteristics of asthma disease. There are no data on BD dose-response relationship in wheezy preschool children whose disease pathophysiology is poorly understood, but may, in part, takes on the characteristics of asthma.
The investigators assume that 1) in young children interrupter resistance (Rint) could be used to measure a BD effect 2) the response to BD may vary depending on the dose used 3) the dose-response relationship could depend on the environment and gene polymorphism ADBR2.
Read more
This is a prospective phase II study on dose-response relationship and description of the dose-response curve design using a "sparse" and a modeling approach MCP-Mod.
The dose-response relationship will be modeled by sparse data. The investigators will test two doses per child in four designs that will be drawn. These doses will be assessed using Rint technique by a person blinded to the actual dose delivered to the child.
Measurements of 90 children will estimate E0, Imax and D50 (pharmacokinetic constants) with an accuracy of 3.5%, 8.9% and 25.7% respectively.
The bronchodilator used in the study is the Salbutamol as Ventolin ® (GSK) suspension for inhalation as an aerosol at a dose of 100μg per puff. Ventolin ® is used as part of the MA (No. 344 387-3)
Read the detailed description
In older children and adults, bronchodilator (BD) dose-effect relationship is part of the characteristics of asthma disease. There are no data on BD dose-response relationship in wheezy preschool children whose disease pathophysiology is poorly understood, but may, in part, takes on the characteristics of asthma.
We assume that 1) in young children interrupter resistance (Rint) could be used to measure a BD effect 2) the response to BD may vary depending on the dose used 3) the dose-response relationship could depend on the environment and gene polymorphism ADBR2.
This is a prospective phase II study on dose-response relationship and description of the dose-response curve design using a "sparse" and a modeling approach MCP-Mod.
The dose-response relationship will be modeled by sparse data. We will test two doses per child in four designs that will be drawn. These doses will be assessed using Rint technique by a person blinded to the actual dose delivered to the child.
Measurements of 90 children will estimate E0, Imax and D50 (pharmacokinetic constants) with an accuracy of 3.5%, 8.9% and 25.7% respectively.
The bronchodilator used in the study is the Salbutamol as Ventolin ® (GSK) suspension for inhalation as an aerosol at a dose of 100μg per puff. Ventolin ® is used as part of the MA (No. 344 387-3) clinical implications The demonstration, first, of the possibility for Rint to detect a dose-response to BD will lead, secondly, to the determination of the minimum dose required for the detection of a reversibility in young children using Rint. It will end a long-standing debate about whether, when no Rint change is observed after BD administration in a young child, the child has actually no reversibility or the BD dose used was not sufficient to demonstrate one.
Moreover, the demonstration of a BD dose-response relationship in young children will suggest similarity between wheezy young children and older children and adults with asthma bronchial behaviour that may have possible therapeutic implications.
- Conditions
- Asthma
- Being tested
- salbutamol, Salbutamol - dose2, Salbutamol -dose3, salbutamol -dose4
- Keywords
- Pediatrics, Bronchial wheeze, bronchodilator, lung function, airway resistance
- 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 Salbutamol -100µg+300µg
Metered dose inhaler, 100µg+300µg per puff, administered one day
Salbutamol - dose2Drug
Also called salbutamol -100µg+500µg
Metered dose inhaler, 100µg+500µg per puff, administered one day
Salbutamol -dose3Drug
Also called salbutamol -200µg+600µg
Metered dose inhaler, 200µg+600µg per puff, administered one day
salbutamol -dose4Drug
Also called salbutamol -200µg+200µg
Metered dose inhaler, 200µg+200µg per puff, administered one day
| Study group | Role | What they receive |
|---|---|---|
| salbutamol - dose 1 | Other | Metered dose inhaler, 100µg+300µg per puff, administered one day Receives: Drug: salbutamol |
| Salbutamol - dose2 | Other | Metered dose inhaler, 100µg+500µg per puff, administered one day Receives: Drug: Salbutamol - dose2 |
| Salbutamol - dose3 | Other | Metered dose inhaler, 200µg+600µg per puff, administered one day Receives: Drug: Salbutamol -dose3 |
| salbutamol - dose4 | Other | Metered dose inhaler, 200µg+200µg per puff, administered one day Receives: Drug: salbutamol -dose4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate of bronchodilator dose-effect
Estimate of bronchodilator dose-effect in young children using the technique of interruption of airflow.
Measured: 90 MINUTES
Secondary outcomes (1)
Determine the minimum dose to be used routinely in a bronchodilator test and study the effect of environment on the dose-effect of the BD and the minimum dose to be used when testing the BD.
Determine the minimum dose of bronchodilator to use during a routine test to bronchodilator in young children to demonstrate bronchial reversibility.
To study the effect of the environment (preventer treatment, atopy, disease control) on the BD dose-response relationship and the minimum BD dose to use to study bronchodilator response.
Study on the genotype of the beta2-adrenergic receptor as a source of variation in the dose-response to bronchodilator.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beydon Nicole, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470755
- Sponsor's protocol ID
- P100504
- Other IDs
- 2011-002261-38
- Acronym
- DORESI
- Status last verified
- Jul 2011
- First submitted
- 9 Nov 2011
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Mukhopadhyay S, Seddon P, Earl G, Wileman E, Symes L, Olden C, Alberti C, Bremner S, Lansley A, Palmer CN, Beydon N. How can we optimise inhaled beta2 agonist dose as 'reliever' medicine for wheezy pre-school children? Study protocol for a randomised controlled trial. Trials. 2016 Nov 11;17(1):541. doi: 10.1186/s13063-016-1437-7.
PubMed 27836009Beydon N, Nguyen TT, Amsallem F, Denjean A, Fenu G, Seddon P, Mentre F, Alberti C, Lombardi E. Interrupter resistance to measure dose-response to salbutamol in wheezy preschool children. Pediatr Pulmonol. 2018 Sep;53(9):1252-1259. doi: 10.1002/ppul.24116. Epub 2018 Jul 3.
PubMed 29972634
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Dose-response to Bronchodilator Then Bronchodilator Dose-finding Using the Flow Interruption Technique in Children Aged 2.5 TO 6 Years
- ClinicalTrials.gov ID
- NCT01470755
- Acronym / sponsor ID
- DORESI / P100504
- Conditions
- Asthma
- Keywords
- Pediatrics, Bronchial wheeze, bronchodilator, lung function, airway resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Nov 2011 (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.
In older children and adults, bronchodilator (BD) dose-effect relationship is part of the characteristics of asthma disease. There are no data on BD dose-response relationship in wheezy preschool children whose disease pathophysiology is poorly understood, but may, in part, takes on the characteristics of asthma.
The investigators assume that 1) in young children interrupter resistance (Rint) could be used to measure a BD effect 2) the response to BD may vary depending on the dose used 3) the dose-response relationship could depend on the environment and gene polymorphism ADBR2.
This is a prospective phase II study on dose-response relationship and description of the dose-response curve design using a "sparse" and a modeling approach MCP-Mod.
The dose-response relationship will be modeled by sparse data. The investigators will test two doses per child in four designs that will be drawn. These doses will be assessed using Rint technique by a person blinded to the actual dose delivered to the child.
Measurements of 90 children will estimate E0, Imax and D50 (pharmacokinetic constants) with an accuracy of 3.5%, 8.9% and 25.7% respectively.
The bronchodilator used in the study is the Salbutamol as Ventolin ® (GSK) suspension for inhalation as an aerosol at a dose of 100μg per puff. Ventolin ® is used as part of the MA (No. 344 387-3)
Detailed description
In older children and adults, bronchodilator (BD) dose-effect relationship is part of the characteristics of asthma disease. There are no data on BD dose-response relationship in wheezy preschool children whose disease pathophysiology is poorly understood, but may, in part, takes on the characteristics of asthma.
We assume that 1) in young children interrupter resistance (Rint) could be used to measure a BD effect 2) the response to BD may vary depending on the dose used 3) the dose-response relationship could depend on the environment and gene polymorphism ADBR2.
This is a prospective phase II study on dose-response relationship and description of the dose-response curve design using a "sparse" and a modeling approach MCP-Mod.
The dose-response relationship will be modeled by sparse data. We will test two doses per child in four designs that will be drawn. These doses will be assessed using Rint technique by a person blinded to the actual dose delivered to the child.
Measurements of 90 children will estimate E0, Imax and D50 (pharmacokinetic constants) with an accuracy of 3.5%, 8.9% and 25.7% respectively.
The bronchodilator used in the study is the Salbutamol as Ventolin ® (GSK) suspension for inhalation as an aerosol at a dose of 100μg per puff. Ventolin ® is used as part of the MA (No. 344 387-3) clinical implications The demonstration, first, of the possibility for Rint to detect a dose-response to BD will lead, secondly, to the determination of the minimum dose required for the detection of a reversibility in young children using Rint. It will end a long-standing debate about whether, when no Rint change is observed after BD administration in a young child, the child has actually no reversibility or the BD dose used was not sufficient to demonstrate one.
Moreover, the demonstration of a BD dose-response relationship in young children will suggest similarity between wheezy young children and older children and adults with asthma bronchial behaviour that may have possible therapeutic implications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| salbutamol - dose 1 | Other | Drug: salbutamolMetered dose inhaler, 100µg+300µg per puff, administered one day |
| Salbutamol - dose2 | Other | Drug: Salbutamol - dose2Metered dose inhaler, 100µg+500µg per puff, administered one day |
| Salbutamol - dose3 | Other | Drug: Salbutamol -dose3Metered dose inhaler, 200µg+600µg per puff, administered one day |
| salbutamol - dose4 | Other | Drug: salbutamol -dose4Metered dose inhaler, 200µg+200µg per puff, administered one day |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Any patient between 2 years 6 months and 6 years 11 months of age referred for pulmonary function testing with bronchodilator test, due to recurrent wheezing ,at least three times in the past year, to LFT laboratories at Armand Trousseau, Robert Debré, both in Paris and Arnaud de VILLENEUVE, in Montpellier hospitals
- No use of bronchodilator in the previous 12 hours before the test
- Parents gave their signed consent for the study
Key exclusion criteria (7 listed)
- with another chronic lung disease (bronchopulmonary dysplasia, chronic bronchitis, viral sequel, pathology of inhalation, thoracic-pulmonary malformation, tracheomalacia), anatomical or functional abnormality of the pharyngolaryngeal tract (tonsils touching or in contact with the uvula, laryngomalacia, subglottic stenosis, vocal cord paralysis, laryngeal obstruction)
- taking regular treatment including leukotrienes receptor antagonist during the week before the test.
- treated with oral glucocorticosteroids within 15 days before the test.
- without social security insurance
- with opposition of the family
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: Salbutamol -100µg+300µgMetered dose inhaler, 100µg+300µg per puff, administered one day | Drug | salbutamol - dose 1 |
| Salbutamol - dose2Also: salbutamol -100µg+500µgMetered dose inhaler, 100µg+500µg per puff, administered one day | Drug | Salbutamol - dose2 |
| Salbutamol -dose3Also: salbutamol -200µg+600µgMetered dose inhaler, 200µg+600µg per puff, administered one day | Drug | Salbutamol - dose3 |
| salbutamol -dose4Also: salbutamol -200µg+200µgMetered dose inhaler, 200µg+200µg per puff, administered one day | Drug | salbutamol - dose4 |
Primary outcome
Estimate of bronchodilator dose-effect
Time frame: 90 MINUTES
Estimate of bronchodilator dose-effect in young children using the technique of interruption of airflow.
1 secondary outcome
Determine the minimum dose to be used routinely in a bronchodilator test and study the effect of environment on the dose-effect of the BD and the minimum dose to be used when testing the BD.
Time frame: 90 minutes
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 6 Feb 2023.
- Results publication: PubMed 27836009Mukhopadhyay S, Seddon P, Earl G, Wileman E, Symes L, Olden C, Alberti C, Bremner S, Lansley A, Palmer CN, Beydon N. How can we optimise inhaled beta2 agonist dose as 'reliever' medicine for wheezy pre-school children? Study protocol for a randomised controlled trial. Trials. 2016 Nov 11;17(1):541. doi: 10.1186/s13063-016-1437-7.
- Results publication: PubMed 29972634Beydon N, Nguyen TT, Amsallem F, Denjean A, Fenu G, Seddon P, Mentre F, Alberti C, Lombardi E. Interrupter resistance to measure dose-response to salbutamol in wheezy preschool children. Pediatr Pulmonol. 2018 Sep;53(9):1252-1259. doi: 10.1002/ppul.24116. Epub 2018 Jul 3.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Beydon Nicole, MD 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?
A Phase 2 study testing salbutamol, Salbutamol - dose2 and Salbutamol -dose3 in people with 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 3 inclusion and 7 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 6 Feb 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Estimate of bronchodilator dose-effect (time frame: 90 MINUTES). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01470755, which also lists 2 linked publications.
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 Feb 2023.