AsthmaNCT01073748
The Effect of Single Dose Paracetamol on the Lower Airways of Asthmatic and Healthy Children
A study testing paracetamol in people with Asthma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- paracetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Assaf Tsivion, M.D
About this study
Official title: The Effect of Paracetamol on Lower Airway Obstruction in Asthmatic Versus Non Asthmatic Children
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- paracetamol
- Keywords
- Asthma, Acetaminophen, paracetamol, FeNO, Spirometry, Lung function
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
Also called Acetaminophen, Acamol
single dose of paracetamol 15mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| asthmatic subjects | Active comparator | Asthmatic children will be randomly exposed to paracetamol and placebo consecutively and their lung functions will be blindly compared. Receives: Drug: paracetamol |
| Healthy children | Other | Children with no asthma as control group. Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
A measurable change in lung functions in response to paracetamol exposure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Ruth Soferman, M.D, Principal investigator, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073748
- Sponsor's protocol ID
- TASMC-10-RS-422-CTIL
- Status last verified
- Jan 2011
- First submitted
- 22 Feb 2010
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Paracetamol on Lower Airway Obstruction in Asthmatic Versus Non Asthmatic Children
- ClinicalTrials.gov ID
- NCT01073748
- Acronym / sponsor ID
- TASMC-10-RS-422-CTIL
- Conditions
- Asthma
- Keywords
- Asthma, Acetaminophen, paracetamol, FeNO, Spirometry, Lung function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (estimated)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asthmatic subjects | Active comparator | Drug: paracetamolAsthmatic children will be randomly exposed to paracetamol and placebo consecutively and their lung functions will be blindly compared. |
| Healthy children | Other | Drug: paracetamolChildren with no asthma as control group. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paracetamolAlso: Acetaminophen, Acamolsingle dose of paracetamol 15mg/kg. | Drug | Healthy children, asthmatic subjects |
Primary outcome
A measurable change in lung functions in response to paracetamol exposure.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Soferman, M.D principal investigator
TASMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paracetamol in people with Asthma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruth Soferman, M.D (972-3-6975691, ruthso@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A measurable change in lung functions in response to paracetamol exposure. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2011.