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

Brief 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

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

Brief Summary

The main purpose of this open randomized, ex-vivo comparative study, is to assess and to<br /> compare the inhalable dose of inhaled corticosteroid collected through a nasal filter and a<br /> mouth filter located in a partitioned face mask and delivered to an infant with asthma via a<br /> 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.