Asthma Clinical Trial
Official title:
The Effect of Paracetamol on Lower Airway Obstruction in Asthmatic Versus Non Asthmatic Children
Asthma is a common inflammatory airway disease. Several researches have demonstrated a
possible connection between asthma and exposure to paracetamol.
Our hypothesis is that even a single dose of paracetamol is sufficient to cause a measurable
change in lung functions.
This trial aims to identify a possible effect of single dose paracetamol on lower airway
function.
Asthma is a common inflammatory airway disease and its prevalence is on the rise all around
the world, Most significantly in children under 5 years.
Paracetamol is one of the most common drugs used with children at thus age groups and
several studies have proved a causative connection between exposure to paracetamol and
asthma prevalence as well as other allergic conditions.
The mechanism is presumably by reduction of glutathione level, resulting in oxidative burst
and formation of reactive oxygen species (ROS).
In addition, paracetamol maybe directly cytotoxic to pneumocytes if given in overdose.
The goal of this research is to identify and quantify the effect of single dose of
paracetamol on lung functions of asthmatic and healthy subjects.
The study group will include 40 children aged 7-16 years, who are known to have asthma and a
control group of 20 healthy children.
The children will be randomized to receive a dose of paracetamol or placebo, and lung
functions will be measured by both spirometry and Fraction of expired Nitric Oxide (FeNO)
test.
Each child will receive both paracetamol and placebo, randomly in to consecutive tests, thus
children will serve as their own control.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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