An interventional study of paracetamol in Asthma, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to participants aged 7 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-25.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Basic science
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.
3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's planned enrollment of 60 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Asthmatic children will be randomly exposed to paracetamol and placebo consecutively and their lung functions will be blindly compared.
Drug: paracetamol
Children with no asthma as control group.
Drug: paracetamol
single dose of paracetamol 15mg/kg.
Also known as: Acetaminophen, Acamol
A measurable change in lung functions in response to paracetamol exposure.
Time frame: 1 year
This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Tel-Aviv Sourasky Medical Center