Lung Function TestsNCT01477645
Health Effects Following Use of Lead Free Ammunition Used With HK416
An observational study of Lung Function Tests and Markers of Inflammation, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether use of lead free ammunitions cause more respiratory problems than use of lead containing ammunitions. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lung Function Tests, Markers of Inflammation
- How many people
- 55 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2011to Mar 2012
- Phase
- Observational
- 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 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Voluntary army soldiers
Who may be able to join
- healthy volunteers
Who cannot join
- active respiratory disease
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian Defence Research Establishment
Kjeller, Akershus, N-2007
About this study
Official title: In Norwegian: Helseffekter av Stoff Som Avgis Ved Skyting Med HK416
The purpose of this study is to determine whether use of lead free ammunitions cause more respiratory problems than use of lead containing ammunitions.
- Conditions
- Lung Function Tests, Markers of Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Leaded ammunition | Not described | |
| Non-leaded ammunition | Not described | |
| Modified non-leaded ammunition | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume (FEV1)
Measured: Before, Immediately after, and 24 hrs after exposure
Secondary outcomes (1)
Inflammation markers
Measured: Before and 24 hrs after esposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Function TestsStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Defence Research Establishment
- Responsible party
- Principal investigator, Svein Grahnstedt, Oslo University Hospital
- Investigators
- Kjetil Longva, PhD, Study director, Norwegian Defence Reasearch EstablishmentAnne-Katrine Borander, MD, Principal investigator, Oslo University HospitalØyvind Albert Voie, PhD, Principal investigator, Norwegian Research Defence EstablishmentJohny S Kongerud, MD PhD, Study director, Oslo University HospitalLiv Ingunn Bjoner Sikkeland, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477645
- Sponsor's protocol ID
- 2011/1335
- Status last verified
- Oct 2013
- First submitted
- 18 Nov 2011
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Borander AK, Voie OA, Longva K, Danielsen TE, Grahnstedt S, Sandvik L, Kongerud J, Sikkeland LIB. Military small arms fire in association with acute decrements in lung function. Occup Environ Med. 2017 Sep;74(9):639-644. doi: 10.1136/oemed-2016-104207. Epub 2017 Apr 13.
PubMed 28408655
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Norwegian: Helseffekter av Stoff Som Avgis Ved Skyting Med HK416
- ClinicalTrials.gov ID
- NCT01477645
- Acronym / sponsor ID
- 2011/1335
- Conditions
- Lung Function Tests, Markers of Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Defence Research Establishment
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Nov 2011 (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.
The purpose of this study is to determine whether use of lead free ammunitions cause more respiratory problems than use of lead containing ammunitions.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leaded ammunition | – | – |
| Non-leaded ammunition | – | – |
| Modified non-leaded ammunition | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Voluntary army soldiers
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- active respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Forced Expiratory Volume (FEV1)
Time frame: Before, Immediately after, and 24 hrs after exposure
1 secondary outcome
Inflammation markers
Time frame: Before and 24 hrs after esposure
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 16 Oct 2013.
- Derived from this study: PubMed 28408655Borander AK, Voie OA, Longva K, Danielsen TE, Grahnstedt S, Sandvik L, Kongerud J, Sikkeland LIB. Military small arms fire in association with acute decrements in lung function. Occup Environ Med. 2017 Sep;74(9):639-644. doi: 10.1136/oemed-2016-104207. Epub 2017 Apr 13.
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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.
Kjetil Longva, PhD study director
Norwegian Defence Reasearch Establishment
Anne-Katrine Borander, MD principal investigator
Oslo University Hospital
Øyvind Albert Voie, PhD principal investigator
Norwegian Research Defence Establishment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Function Tests and Markers of Inflammation, 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 1 inclusion and 1 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 16 Oct 2013. 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?
Forced Expiratory Volume (FEV1) (time frame: Before, Immediately after, and 24 hrs after exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477645, which also lists 1 linked publication.
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 16 Oct 2013.