Chronic Obstructive Pulmonary DiseaseNCT00839735
Trefoil Peptides in Lung Diseases
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The study focuses on trefoil family factor (TFF) peptides in sputum in lung diseases. The investigators hypothesize that TFF peptides are upregulated in lung diseases characterized by mucus hypersecretion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2009to May 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with chronic obstruction pulmonary disease (COPD) Subjects with asthma Healthy volunteers
Who may be able to join
- Age 18 years or older
- Informed consent
Who cannot join
- Upper and lower airway infection 2 weeks prior to visit 1
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Respiratory and Allergy Research Unit, Department of Respiratory Medicine L, Bispebjerg Hospital
Copenhagen, 2400
About this study
The study focuses on trefoil family factor (TFF) peptides in sputum in lung diseases. The investigators hypothesize that TFF peptides are upregulated in lung diseases characterized by mucus hypersecretion.
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
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 |
|---|---|---|
| COPD | Chronic obstructive pulmonary disease | |
| Asthma | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
TFF in sputum
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Lund, Bispebjerg Hospital
- Investigators
- Thomas K Lund, MD PhD, Principal investigator, Respiratory and Allergy Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839735
- Sponsor's protocol ID
- H-B-2008-120
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2009
- Last updated
- 17 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trefoil Peptides in Lung Diseases
- ClinicalTrials.gov ID
- NCT00839735
- Acronym / sponsor ID
- H-B-2008-120
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Feb 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.
The study focuses on trefoil family factor (TFF) peptides in sputum in lung diseases. The investigators hypothesize that TFF peptides are upregulated in lung diseases characterized by mucus hypersecretion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD | – | –Chronic obstructive pulmonary disease |
| Asthma | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with chronic obstruction pulmonary disease (COPD) Subjects with asthma Healthy volunteers
Key inclusion criteria (2 listed)
- Age 18 years or older
- Informed consent
Key exclusion criteria (1 listed)
- Upper and lower airway infection 2 weeks prior to visit 1
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
TFF in sputum
Time frame: Monthly
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 17 Feb 2021.
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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.
Thomas K Lund, MD PhD principal investigator
Respiratory and Allergy Research Unit
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 Chronic Obstructive Pulmonary Disease and Asthma, run by Bispebjerg Hospital at 1 site in Denmark.
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 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 17 Feb 2021. 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 Denmark. 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?
TFF in sputum (time frame: Monthly). 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 17 Feb 2021.