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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 (MASQUE)

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ClinicalTrials.gov Identifier: NCT03364959
Recruitment Status : Unknown
Verified November 2017 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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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

Condition or disease Intervention/treatment Phase
Asthma in Children Other: Corticosteroids inhalation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arms and Interventions
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Arm Intervention/treatment
Experimental: Flixotide
Patients inhale first Flixotide and then Qvar
 Other: 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
Experimental: Qvar
Patients inhale first Qvar and then Flixotide
 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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage (%) of corticoisteroids proportion delivered to the nose with respect to the mouth by chromatography. [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364959


Contacts
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Contact: Jean-Christophe DUBUS, PD-PhD 491386816 ext +33 JeanChristophe.DUBUS@ap-hm.fr
Contact: Camille DELANNOY, Manager 491382747 ext +33 drci@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: jean christophe DUBUS       jdubus@ap-hm.fr   
Sub-Investigator: jean christophe DUBUS         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD, Director Assistance Publique Hôpitaux de Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03364959    
Other Study ID Numbers: 2016-47
2016-A01839-42 ( Other Identifier: ANSM )
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Asthma
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
 Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases