Study of Dose-response to Bronchodilator and Dose-finding in Child 2.5 to 6 Years - Study Golden
DORESI
Study on Dose-response to Bronchodilator Then Bronchodilator Dose-finding Using the Flow Interruption Technique in Children Aged 2.5 TO 6 Years
2 other identifiers
interventional
90
1 country
1
Brief 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. 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Jan 2012
Typical duration for phase_2 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2011
CompletedFirst Posted
Study publicly available on registry
November 11, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFebruary 6, 2023
July 1, 2011
2 years
November 9, 2011
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimate of bronchodilator dose-effect
Estimate of bronchodilator dose-effect in young children using the technique of interruption of airflow.
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.
90 minutes
Study Arms (4)
salbutamol - dose 1
OTHERMetered dose inhaler, 100µg+300µg per puff, administered one day
Salbutamol - dose2
OTHERMetered dose inhaler, 100µg+500µg per puff, administered one day
Salbutamol - dose3
OTHERMetered dose inhaler, 200µg+600µg per puff, administered one day
salbutamol - dose4
OTHERMetered dose inhaler, 200µg+200µg per puff, administered one day
Interventions
Metered dose inhaler, 100µg+300µg per puff, administered one day
Metered dose inhaler, 100µg+500µg per puff, administered one day
Metered dose inhaler, 200µg+600µg per puff, administered one day
Metered dose inhaler, 200µg+200µg per puff, administered one day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beydon
Paris, 75012, France
Related Publications (2)
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.
PMID: 27836009RESULTBeydon 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.
PMID: 29972634RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beydon Nicole, MD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2011
First Posted
November 11, 2011
Study Start
January 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
February 6, 2023
Record last verified: 2011-07