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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01073748
• Other study ID #: TASMC-10-RS-422-CTIL
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2010
• Last updated: January 23, 2011
• Start date: March 2010

Study information

• Verified date: January 2011
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ruth Soferman, M.D
• Phone: 972-3-6975691
• Email: ruthso[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• paracetamol
single dose of paracetamol 15mg/kg.

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A measurable change in lung functions in response to paracetamol exposure.		1 year	No