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

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
paracetamol
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma focused on measuring Asthma, Acetaminophen, paracetamol, FeNO, Spirometry, Lung function

Eligibility Criteria

7 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tel Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

asthmatic subjects

Healthy children

Arm Description

Asthmatic children will be randomly exposed to paracetamol and placebo consecutively and their lung functions will be blindly compared.

Children with no asthma as control group.

Outcomes

Primary Outcome Measures

A measurable change in lung functions in response to paracetamol exposure.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2010
Last Updated
January 23, 2011
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01073748
Brief Title
The Effect of Single Dose Paracetamol on the Lower Airways of Asthmatic and Healthy Children
Official Title
The Effect of Paracetamol on Lower Airway Obstruction in Asthmatic Versus Non Asthmatic Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Acetaminophen, paracetamol, FeNO, Spirometry, Lung function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
asthmatic subjects
Arm Type
Active Comparator
Arm Description
Asthmatic children will be randomly exposed to paracetamol and placebo consecutively and their lung functions will be blindly compared.
Arm Title
Healthy children
Arm Type
Other
Arm Description
Children with no asthma as control group.
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
Acetaminophen, Acamol
Intervention Description
single dose of paracetamol 15mg/kg.
Primary Outcome Measure Information:
Title
A measurable change in lung functions in response to paracetamol exposure.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Soferman, M.D
Phone
972-3-6975691
Email
ruthso@tasmc.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Assaf Tsivion, M.D
Phone
972-52-7360333
Email
assaft@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Soferman, M.D
Organizational Affiliation
TASMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assaf Tsivion, M.D

12. IPD Sharing Statement

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

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