Status:
TERMINATED
Ex Vivo Pilot Study of the Impact of Nasal Breathing During the Administration of Inhaled Corticosteroids by Inhalation Chamber in Asthmatic Children Ages Between 1 and 4-year-old
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Asthma in Children
Eligibility:
All Genders
1-4 years
Phase:
NA
Brief Summary
The main purpose of this open randomized, ex-vivo comparative study, is to assess and to compare the inhalable dose of inhaled corticosteroid collected through a nasal filter and a mouth filter locate...
Detailed Description
The use of a face mask is recommended for inhaled treatments delivered from a pressurized metered-dose inhaler and a spacer device in infants and young children with respiratory disorders such as asth...
Eligibility Criteria
Inclusion
- Aged from 1 to 4 years old
- Male or female
- With medically diagnosed asthma
- Patients who are used to use an inhalation chamber with a face mask
- Patients who have not had asthmatic decompensation for at least 1 month.
- Patients' parents having given their written consent
- With normal clinical respiratory examination on the day of the test.
Exclusion
- Patients whose parents are unable to understand the purpose and conditions of the study
- Patients whose parents are unable to give their consent
- Patients participating in another clinical trial or exclusion period from a previous clinical trial
- Patients presenting with a nasopharyngeal infection in the previous month
- Child with nasal obstruction, nocturnal snoring, adenoid facies or facial malformation
- Patient presenting with an asthmatic decompensation episode in the previous month
Key Trial Info
Start Date :
October 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03364959
Start Date
October 23 2018
End Date
July 9 2021
Last Update
June 7 2024
Active Locations (1)
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1
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354