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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2010
CompletedFirst Posted
Study publicly available on registry
February 23, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedJanuary 25, 2011
January 1, 2011
1 year
February 22, 2010
January 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A measurable change in lung functions in response to paracetamol exposure.
1 year
Study Arms (2)
asthmatic subjects
ACTIVE COMPARATORAsthmatic children will be randomly exposed to paracetamol and placebo consecutively and their lung functions will be blindly compared.
Healthy children
OTHERChildren with no asthma as control group.
Interventions
single dose of paracetamol 15mg/kg.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruth Soferman, M.D
TASMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
February 22, 2010
First Posted
February 23, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2011
Last Updated
January 25, 2011
Record last verified: 2011-01