Asthma | The Effect of Single Dose Paracetamol on the Lower Airways of Asthmatic and Healthy Children
Asthma research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:paracetamolsingle dose of paracetamol 15mg/kg.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
asthmatic subjectsAsthmatic children will be randomly exposed to paracetamol and placebo consecutively and their lung functions will be blindly compared.
Healthy childrenChildren with no asthma as control group.
Start Date: March 2010
Primary Outcome: A measurable change in lung functions in response to paracetamol exposure.
Study sponsors, principal investigator, and references
Principal Investigator: Ruth Soferman, M.D
Lead Sponsor: Tel-Aviv Sourasky Medical Center