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

NCT ID: NCT03364959

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2021-07-09

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

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 asthma.

The nose effectively filters the air particles and it may reduce the amount of inhaled drug. Thus it is reported that the drug deposited in the lung dose is halved in older children inhaling through the nose with respect to those inhaling through the mouth.

In very young children the efficiency of nasal filtration is unknown for inhaled treatment. In infants, an in-vitro study suggests that nasal breathing allows a similar or more important drug delivery than mouth breathing, contrary to what is observed in the oldest and adults.

So it seems of great import to characterize the drug delivery in this age group comparing the nasal with the mouth breathing.

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. 60 children, aged between 1 and 4 years old, with a medically diagnosed asthma will be recruited. Each child will inhale four puffs of both Fluticasone 125 µg/puff and Beclometasone dipropionate 100 µg/puff administered by a single observer in a standardized and randomized way. No drug will be inhaled by the children. The drugs collected on the filters between the holding chamber and patient will be analysed by high performance liquid chromatography HPLC). Filter doses will be expressed in percentage of the total dose filtered. The analysis will cover the difference between oral dose and nasal dose compared to zero. Student's test will be performed with p < 0.05.

Conditions

Asthma in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flixotide

Patients inhale first Flixotide and then Qvar

Group Type: EXPERIMENTAL

Corticosteroids inhalation

Intervention Type: 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

Qvar

Patients inhale first Qvar and then Flixotide

Group Type: EXPERIMENTAL

Corticosteroids inhalation

Intervention Type: OTHER

Qvar inhalation followed by Flixotide 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

Interventions

Corticosteroids inhalation

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

Intervention Type: OTHER

Corticosteroids inhalation

Qvar inhalation followed by Flixotide 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Olivier ARNAUD, Director

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2016-A01839-42

Identifier Type: OTHER

Identifier Source: secondary_id

2016-47

Identifier Type: -

Identifier Source: org_study_id