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

NCT03364959 | Terminated

• 2 other identifiers: 2016-472016-A01839-42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 located in a partitioned face mask and delivered to an infant with asthma via a Tipshaler® holding chamber

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Percentage (%) of corticoisteroids proportion delivered to the nose with respect to the mouth by chromatography.

  Compare by chromatography the proportion of product administered to the nose with respect to the mouth for the administration of inhaled corticosteroids in children with asthma. Filter doses will be expressed as a percentage of the total filtered dose.

  12 months

Study Arms (2)

Flixotide

EXPERIMENTAL

Patients inhale first Flixotide and then Qvar

Other: Corticosteroids inhalation

Qvar

EXPERIMENTAL

Patients inhale first Qvar and then Flixotide

Other: Corticosteroids inhalation

Interventions

Corticosteroids inhalation OTHER

Flixotide inhalation followed by Qvar inhalation through a nasal filter and a mouth filter located in a partitioned face mask and delivered to an infant with asthma via a Tipshaler® holding chamber

Flixotide

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patients whose parents are unable to understand the purpose and conditions of the study
• Patients whose parents are unable to give their consent
• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Officials

• Jean-Olivier ARNAUD, Director

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: December 7, 2017
• Study Start: October 23, 2018
• Primary Completion: October 10, 2019
• Study Completion: July 9, 2021
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

FR (1)