Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT03364959
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.
Study:
NCT03364959
Study Brief:
Protocol Section:
NCT03364959