BronchiectasisNCT01906047
Impact of Chronic Air Pollution on Non-cystic Fibrosis Bronchiectasis
An observational study of Bronchiectasis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
We aim at investigation the impact of chronic air pollution exposure on non-cystic fibrosis bronchiectasis outcome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchiectasis
- How many people
- 189 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2006to Apr 2013
- How long will I take part?
- 6 Years
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a HRCT diagnosis of bronchiectasis and do not have a diagnosis of cystic fibrosis. They also need to have typical bronchiectatic disease (recurrent infections and sputum).
Who may be able to join
- HRCT diagnosis of bronchiectasis
- recurrent infections or chronic sputum production
- patients between 18 and 65 years old.
Who cannot join
- Cystic Fibrosis
- Tumoral disease
- Traction bronchiectasis due to interstitial lung disease
- patients older than 65 years or younger than 18 years at recruitment
- COPD
Trial locations and contacts
1 site in 1 country.
About this study
We aim at investigation the impact of chronic air pollution exposure on non-cystic fibrosis bronchiectasis outcome.
Read the detailed description
- Patient files will be search for time of death and cause of death.
- Other variables will be collected: bacterial culture results, therapy, gender, age, etc.
- These data will be linked with pollution data: trafic load, distance to major road, etc.
- Conditions
- Bronchiectasis
- Keywords
- Non-cystic fibrosis bronchiectasis
- Medical subject headings
- Bronchiectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
From June 2006 till October 2012, enrolled patients' medical file will be screened if death has occurred. If so, cause of death will be search for in the patients' file.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJun 2006
- Primary completionOct 2012
- Study completionApr 2013
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 BronchiectasisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lieven Dupont, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Lieven J Dupont, MD, PhD, Principal investigator, UZ LeuvenPieter C Goeminne, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906047
- Sponsor's protocol ID
- NCFB chronic pollution
- Status last verified
- Jul 2013
- First submitted
- 18 Jul 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Goeminne PC, Bijnens E, Nemery B, Nawrot TS, Dupont LJ. Impact of traffic related air pollution indicators on non-cystic fibrosis bronchiectasis mortality: a cohort analysis. Respir Res. 2014 Sep 3;15(1):108. doi: 10.1186/s12931-014-0108-z.
PubMed 25183428
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Air Pollution on Non-cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT01906047
- Acronym / sponsor ID
- NCFB chronic pollution
- Conditions
- Bronchiectasis
- Keywords
- Non-cystic fibrosis bronchiectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 Jul 2013 (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.
We aim at investigation the impact of chronic air pollution exposure on non-cystic fibrosis bronchiectasis outcome.
Detailed description
- Patient files will be search for time of death and cause of death.
- Other variables will be collected: bacterial culture results, therapy, gender, age, etc.
- These data will be linked with pollution data: trafic load, distance to major road, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a HRCT diagnosis of bronchiectasis and do not have a diagnosis of cystic fibrosis. They also need to have typical bronchiectatic disease (recurrent infections and sputum).
Key inclusion criteria (3 listed)
- HRCT diagnosis of bronchiectasis
- recurrent infections or chronic sputum production
- patients between 18 and 65 years old.
Key exclusion criteria (5 listed)
- Cystic Fibrosis
- Tumoral disease
- Traction bronchiectasis due to interstitial lung disease
- patients older than 65 years or younger than 18 years at recruitment
- COPD
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
Death
Time frame: 6 years
From June 2006 till October 2012, enrolled patients' medical file will be screened if death has occurred. If so, cause of death will be search for in the patients' file.
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 23 Jul 2013.
- Derived from this study: PubMed 25183428Goeminne PC, Bijnens E, Nemery B, Nawrot TS, Dupont LJ. Impact of traffic related air pollution indicators on non-cystic fibrosis bronchiectasis mortality: a cohort analysis. Respir Res. 2014 Sep 3;15(1):108. doi: 10.1186/s12931-014-0108-z.
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Bronchiectasis
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.
Lieven J Dupont, MD, PhD principal investigator
UZ Leuven
Pieter C Goeminne, MD principal investigator
UZ Leuven
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 Bronchiectasis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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: finished, as of the sponsor's last update on 23 Jul 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 Belgium. 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?
Death (time frame: 6 years). 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 NCT01906047, 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 23 Jul 2013.