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NCT01470755: DORESI
Study on Dose-response to Bronchodilator Then Bronchodilator Dose-finding Using the Flow Interruption Technique in Children Aged 2.5 TO 6 Years
Phase 2 trial testing salbutamol in Asthma in 90 participants. Completed in 1 January 2014.
1 January 2014
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 1 January 2012 |
| Primary completion | 1 January 2014 |
| Estimated completion | 1 January 2014 |
| Sites | 1 location across France |
Drugs / interventions tested
- salbutamol (salbutamol) — full drug profile →
- Salbutamol - dose2 — full drug profile →
- Salbutamol -dose3
- salbutamol -dose4
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 2 to 6, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Estimate of bronchodilator dose-effect
Time frame: 90 MINUTES
Estimate of bronchodilator dose-effect in young children using the technique of interruption of airflow.
Sponsor's own 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. 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)
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01470755
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Asthma
Currently open trials in the same condition.
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Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01470755 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 3 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01470755.
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