Bronchial AsthmaNCT01240707
Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation
A study testing Fiberoptic bronchoscopy in people with Bronchial Asthma, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Fire smoke inhalation may contribute to intrabronchial inflammation, airway obstruction and impaired gas exchange. In this study the investigators will examine if the scope of inhalation injury can be assessed soon after hospital admission based on clinical markers, biochemical markers, Peak Expiratory Flow (PEF)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Fiberoptic bronchoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2010to May 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fire smoke exposed patient
- > 18 years of age
- admitted to hospital
Who cannot join
- < 18 years of ager
- trauma patient
- Control group (healthy volunteers/hospital staff):
- > 18 years of age
- non-smoker
- no exposure to fire smoke
Trial locations and contacts
1 site in 1 country.
About this study
Fire smoke inhalation may contribute to intrabronchial inflammation, airway obstruction and impaired gas exchange. In this study the investigators will examine if the scope of inhalation injury can be assessed soon after hospital admission based on clinical markers, biochemical markers, Peak Expiratory Flow (PEF), spirometry and bronchoscopy. At 6 months a lung function test and metacholine test will be performed to examine whether patients have developed increased bronchial hyperreactivity (asthma) or not after the initial fire smoke exposure.
Read the detailed description
Fire smoke inhalation may contribute to intrabronchial inflammation, airway obstruction and impaired gas exchange. The scope of injury in fire smoke victims ranges from cough and minor airway irritation to severe respiratory failure and long term mechanical ventilation in the Intensive Care Unit. Some patients with high HbCO-levels are also treated with hyperbaric oxygen therapy.
In this study the investigators will examine if the scope of inhalation injury can be assessed soon after admission based on clinical markers, biochemical markers, Peak Expiratory Flow (PEF), spirometry and bronchoscopy. The clinical effect of fiberoptic bronchoscopy after severe smoke inhalation will also be examined. At 6 months a lung function test and metacholine test will be performed to examine whether they have developed asthma/increased bronchial hyperreactivity or not after the initial fire smoke exposure. Lab staff (flowcytometer and cytokine analysis) are unaware of patient identity and whether the patient is a smoke-exposed patient or a healthy volunteer in the control group of non-exposed persons.
- Conditions
- Bronchial Asthma
- Being tested
- Fiberoptic bronchoscopy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiberoptic bronchoscopyOther
Also called Bronchopscopy
Fiberoptic bronchoscopy performed to remove secretions and assess soot in central airways
| Study group | Role | What they receive |
|---|---|---|
| LF tests, Fiberoptic bronchoscopy | Other | Spirometry, Peak Expiratory Flow (PEF). Bronchoscopic assessment of soot in central airways. Receives: Other: Fiberoptic bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive metacholine test (bronchial hyperreactivity).
At 6 months a lung function test and metacholine test will be performed to examine whether patients have developed asthma/increased bronchial hyperreactivity after the initial fire smoke exposure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Espen Rostrup Nakstad, Oslo University Hospital
- Investigators
- Espen R Nakstad, MD, Principal investigator, Oslo University Hospital - Ulleval, NorwayHelge Opdahl, MD, PhD, Study director, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240707
- Sponsor's protocol ID
- REK S-O, Ref 2010/1340, part A
- Status last verified
- Sep 2016
- First submitted
- 10 Nov 2010
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation
- ClinicalTrials.gov ID
- NCT01240707
- Acronym / sponsor ID
- REK S-O, Ref 2010/1340, part A
- Conditions
- Bronchial Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Nov 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.
Fire smoke inhalation may contribute to intrabronchial inflammation, airway obstruction and impaired gas exchange. In this study the investigators will examine if the scope of inhalation injury can be assessed soon after hospital admission based on clinical markers, biochemical markers, Peak Expiratory Flow (PEF), spirometry and bronchoscopy. At 6 months a lung function test and metacholine test will be performed to examine whether patients have developed increased bronchial hyperreactivity (asthma) or not after the initial fire smoke exposure.
Detailed description
Fire smoke inhalation may contribute to intrabronchial inflammation, airway obstruction and impaired gas exchange. The scope of injury in fire smoke victims ranges from cough and minor airway irritation to severe respiratory failure and long term mechanical ventilation in the Intensive Care Unit. Some patients with high HbCO-levels are also treated with hyperbaric oxygen therapy.
In this study the investigators will examine if the scope of inhalation injury can be assessed soon after admission based on clinical markers, biochemical markers, Peak Expiratory Flow (PEF), spirometry and bronchoscopy. The clinical effect of fiberoptic bronchoscopy after severe smoke inhalation will also be examined. At 6 months a lung function test and metacholine test will be performed to examine whether they have developed asthma/increased bronchial hyperreactivity or not after the initial fire smoke exposure. Lab staff (flowcytometer and cytokine analysis) are unaware of patient identity and whether the patient is a smoke-exposed patient or a healthy volunteer in the control group of non-exposed persons.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LF tests, Fiberoptic bronchoscopy | Other | Other: Fiberoptic bronchoscopySpirometry, Peak Expiratory Flow (PEF). Bronchoscopic assessment of soot in central airways. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- fire smoke exposed patient
- > 18 years of age
- admitted to hospital
Key exclusion criteria (6 listed)
- < 18 years of ager
- trauma patient
- > 18 years of age
- non-smoker
- no exposure to fire smoke
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 |
|---|---|---|
| Fiberoptic bronchoscopyAlso: BronchopscopyFiberoptic bronchoscopy performed to remove secretions and assess soot in central airways | Other | LF tests, Fiberoptic bronchoscopy |
Primary outcome
Positive metacholine test (bronchial hyperreactivity).
Time frame: 6 months
At 6 months a lung function test and metacholine test will be performed to examine whether patients have developed asthma/increased bronchial hyperreactivity after the initial fire smoke exposure.
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 27 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Espen R Nakstad, MD principal investigator
Oslo University Hospital - Ulleval, Norway
Helge Opdahl, MD, PhD study director
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiberoptic bronchoscopy in people with Bronchial Asthma, run by Oslo University Hospital at 1 site in Norway.
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 6 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 27 Sep 2016. 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 Norway. 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?
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.
What does the primary outcome measure?
Positive metacholine test (bronchial hyperreactivity). (time frame: 6 months). 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 27 Sep 2016.