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The Effect of Single Dose Paracetamol on the Lower Airways of Asthmatic and Healthy Children

The Effect of Paracetamol on Lower Airway Obstruction in Asthmatic Versus Non Asthmatic Children

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01073748
Enrollment
60
Registered
2010-02-23
Start date
2010-03-31
Completion date
Unknown
Last updated
2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Acetaminophen, paracetamol, FeNO, Spirometry, Lung function

Brief summary

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.

Detailed description

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.

Interventions

DRUGparacetamol

single dose of paracetamol 15mg/kg.

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

* age: 7-16 years * research group: children who have been diagnosed as asthmatic according to the American thoracic society (ATS) criteria * control group: children who are not known to have asthma

Exclusion criteria

* paracetamol sensitivity * children with any kind of chronic disease (except asthma) * children with non asthma related chronic lung disease * acute asthma attack * children on systemic steroids

Design outcomes

Primary

MeasureTime frame
A measurable change in lung functions in response to paracetamol exposure.1 year

Countries

Israel

Contacts

Primary ContactRuth Soferman, M.D
ruthso@tasmc.health.gov.il972-3-6975691
Backup ContactAssaf Tsivion, M.D
assaft@hotmail.com972-52-7360333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026