Post Bronchoscopy FeverPhase 2NCT00954200
Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever
A Phase 2 study testing ibuprofen in people with Post Bronchoscopy Fever, run by Shaare Zedek Medical Center at 2 sites in Israel.
Trial summary
Scientific background: Bronchoscopy is a procedure commonly performed in the management of persistent respiratory illness. In the last decades this exam has become a routine and safe procedure even in children and there are few side-effects. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Post Bronchoscopy Fever
- What is being tested?
- ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesIsrael
- Study dates
- Start not givento Jan 2015
- Phase
- Phase 2
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- under twelve years of age
- all patients undergoing bronchoscopy and bronchoalveolar lavage
Who cannot join
- children with immune deficiency
- allergy to NSAIDS
- previous exacerbation of asthma due to NSAIDS
- fever on the day of the examination
- current antibiotic treatment
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Shaare Zedek Medical Center POB 3235
Jerusalem, 91031
Shaare Zedek Medical Center
Jerusalem
About this study
Scientific background: Bronchoscopy is a procedure commonly performed in the management of persistent respiratory illness. In the last decades this exam has become a routine and safe procedure even in children and there are few side-effects. However, one known side effect is transient fever and even high fever a few hours after the bronchoscopy. This side effect is not dangerous but very uncomfortable for the patients and it would be interesting to try to reduce this phenomena. This fever is due to a release of cytokines during the broncho-alveolar lavage procedure and not to sepsis. In a previous study a single dose of dexamethasone was shown to prevent the fever post bronchoscopy with no apparent detriment to the child. It is well known that steroids are immunosuppressive. Even though the post-bronchoscopy fever is not caused by an infection, it seems preferable to use other anti-inflammatory drugs to fight this very inconvenient side effect.
Ibuprofen (Nurofen*) is known as an effective medication to reduce fever in infectious illnesses and is even considered as superior to paracetamol. It has no immunosuppressive effect and is usually well tolerated by children with very few side effects when taken in the normal therapeutic dose of 10mg/Kg. The investigators postulate that a dose of Nurofen prior to bronchoscopy could significantly reduce fever post bronchoscopy.
- Conditions
- Post Bronchoscopy Fever
- Being tested
- ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofenDrug
ibuprofen 10mg/kg syrup, single dose vs placebo
ibuprofenDrug
10mg/kg syrup - single dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: ibuprofen |
| ibuprofen | Active comparator | Not described Receives: Drug: ibuprofen |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Bronchoscopy FeverStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954200
- Sponsor's protocol ID
- 26.07.09.ctil
- Status last verified
- Oct 2020
- First submitted
- 26 Jul 2009
- Last updated
- 26 Oct 2020
- Results posted
- No
Publications
Picard E, Schwartz S, Goldberg S, Glick T, Villa Y, Kerem E. A prospective study of fever and bacteremia after flexible fiberoptic bronchoscopy in children. Chest. 2000 Feb;117(2):573-7. doi: 10.1378/chest.117.2.573.
PubMed 10669705Fonseca MT, Camargos PA, Abou Taam R, Le Bourgeois M, Scheinmann P, de Blic J. Incidence rate and factors related to post-bronchoalveolar lavage fever in children. Respiration. 2007;74(6):653-8. doi: 10.1159/000107737. Epub 2007 Aug 29.
PubMed 17728531
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever
- ClinicalTrials.gov ID
- NCT00954200
- Acronym / sponsor ID
- 26.07.09.ctil
- Conditions
- Post Bronchoscopy Fever
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Aug 2009 (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.
Scientific background: Bronchoscopy is a procedure commonly performed in the management of persistent respiratory illness. In the last decades this exam has become a routine and safe procedure even in children and there are few side-effects. However, one known side effect is transient fever and even high fever a few hours after the bronchoscopy. This side effect is not dangerous but very uncomfortable for the patients and it would be interesting to try to reduce this phenomena. This fever is due to a release of cytokines during the broncho-alveolar lavage procedure and not to sepsis. In a previous study a single dose of dexamethasone was shown to prevent the fever post bronchoscopy with no apparent detriment to the child. It is well known that steroids are immunosuppressive. Even though the post-bronchoscopy fever is not caused by an infection, it seems preferable to use other anti-inflammatory drugs to fight this very inconvenient side effect.
Ibuprofen (Nurofen*) is known as an effective medication to reduce fever in infectious illnesses and is even considered as superior to paracetamol. It has no immunosuppressive effect and is usually well tolerated by children with very few side effects when taken in the normal therapeutic dose of 10mg/Kg. The investigators postulate that a dose of Nurofen prior to bronchoscopy could significantly reduce fever post bronchoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: ibuprofen |
| ibuprofen | Active comparator | Drug: ibuprofen |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- under twelve years of age
- all patients undergoing bronchoscopy and bronchoalveolar lavage
Key exclusion criteria (5 listed)
- children with immune deficiency
- allergy to NSAIDS
- previous exacerbation of asthma due to NSAIDS
- fever on the day of the examination
- current antibiotic treatment
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 |
|---|---|---|
| ibuprofenibuprofen 10mg/kg syrup, single dose vs placebo | Drug | ibuprofen |
| ibuprofen10mg/kg syrup - single dose | Drug | Placebo, ibuprofen |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Background: PubMed 10669705Picard E, Schwartz S, Goldberg S, Glick T, Villa Y, Kerem E. A prospective study of fever and bacteremia after flexible fiberoptic bronchoscopy in children. Chest. 2000 Feb;117(2):573-7. doi: 10.1378/chest.117.2.573.
- Background: PubMed 17728531Fonseca MT, Camargos PA, Abou Taam R, Le Bourgeois M, Scheinmann P, de Blic J. Incidence rate and factors related to post-bronchoalveolar lavage fever in children. Respiration. 2007;74(6):653-8. doi: 10.1159/000107737. Epub 2007 Aug 29.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ibuprofen in people with Post Bronchoscopy Fever, run by Shaare Zedek Medical Center at 2 sites 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 2 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: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00954200, which also lists 2 linked publications.
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 26 Oct 2020.