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 : Recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma in Children||Other: Corticosteroids inhalation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- 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.
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
|Contact: Jean-Christophe DUBUS, PD-PhD||491386816 ext +33||JeanChristophe.DUBUS@ap-hm.fr|
|Contact: Camille DELANNOY, Manager||491382747 ext +email@example.com|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: jean christophe DUBUS firstname.lastname@example.org|
|Sub-Investigator: jean christophe DUBUS|
|Study Director:||Jean-Olivier ARNAUD, Director||Assistance Publique Hôpitaux de Marseille|