Pulmonary Disease, Chronic ObstructiveNCT00655954
Osteoprotegerin (OPG) in Induced Chronic Obstructive Pulmonary Disease (COPD) Sputum
An observational study of Pulmonary Disease, Chronic Obstructive, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Evaluation of OPG level as disease markers has also been reported. It has been showed that patients with coronary artery disease had higher serum OPG levels than healthy volunteers. Moreover, serum OPG levels correlate with the number of stenotic coronary arteries Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Induced sputum
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2008to Mar 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants were recruited from the outpatient department of Royal Brompton Hospital and local general practices. Patients with COPD were diagnosed using the GOLD (Global Initiative for Obstructive Lung Disease) criteria. 25 Patients with COPD who had an exacerbation during the last 2 months prior to the visit were excluded. Patients with asthma were diagnosed using the GINA (Global Initiative for Asthma) guidelines for asthma. 26 Patients with any other lung diseases were excluded from the study. This study was reviewed and approved by the Hounslow and Hillingdon Research Ethics Committee. Written informed consent was obtained from all subjects.
Who may be able to join
- Healthy non-smokers
- Age <35 years (younger group)
- Aged matched to COPD patients (older group)
- Normal spirometry
- Subjects are able to give informed consent
- Healthy smokers
Show all 21Show fewer
- Age <35 years (younger group)
- Aged matched to COPD patients (older group)
- Normal spirometry
- Subjects are able to give informed consent Stable COPD patients: Stage I-IV according to the GOLD guidelines (3), (9)
- Current and/or ex-smokers with no less than 10 pack-year smoking history
- The subjects are able to give informed consent COPD patients with acute exacerbation: Stage I-IV according to the GOLD guidelines (3), (9)
- Exacerbation of COPD defined as "an event in the natural course of the disease characterised by a change in the patient's baseline dyspnoea, cough and/or sputum beyond day to day variability sufficient to warrant a change in management" (9)
- Current and/or ex-smokers with no less than 10 pack-year smoking history
- The subjects are able to give informed consent Asthma patients
- Patients diagnosed with asthma
- The subjects are able to give informed consent Bronchiectasis patients
- Patients with CT-confirmed bronchiectasis
- The subjects are able to give informed consent Cystic fibrosis patients
- Patients diagnosed with cystic fibrosis
- The subjects are able to give informed consent
Who cannot join
- Healthy non-smokers and smokers
- Upper respiratory infection within the last 4 weeks.
- Subjects who have received research medication within the previous one month.
- Subjects unable to give informed consent.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study Stable COPD patients
- Patients who have had an exacerbation which required treatment with oral steroids during the last 2 months prior to the visit
Show all 21Show fewer
- Upper respiratory infection within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study COPD patients with acute exacerbation
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study Asthma
- Upper respiratory infection within the last 4 weeks
- Subjects who have received research medication within the previous one month
- Subjects unable to give informed consent.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- Bronchiectasis and cystic fibrosis
- Subjects who have received research medication within the previous one month.
- Subjects unable to give informed consent.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteoprotegerin (OPG) in Induced Sputum as a Novel Biomarker for COPD
Evaluation of OPG level as disease markers has also been reported. It has been showed that patients with coronary artery disease had higher serum OPG levels than healthy volunteers. Moreover, serum OPG levels correlate with the number of stenotic coronary arteries
Read the detailed description
Osteoprotegerin (OPG) is a secreted glycoprotein containing 401 amino acids. It is a member of the tumour necrosis factor (TNF) receptor superfamily. It was firstly discovered as a protein regulating bone metabolism, inhibiting osteoclastogenesis, consequently, inhibiting bone resorption OPG is detected in lung using Northern blot analysis. It is likely that OPG would contribute to the pathogenesis of COPD and could be an effective disease marker of the disease
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Induced sputum
- Keywords
- COPD, asthma, smokers, healthy volunteers, bronchiectasis, cystic fibrosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Bronchiectasis, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced sputumProcedure or surgery
Used Ultrasonic nebuliser
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers non smoker | 18 volunteers Receives: Procedure: Induced sputum | |
| Healthy volunteers smoker | 15 volunteers Receives: Procedure: Induced sputum | |
| Chronic Obstructive Pulmonary Disease COPD | 39 volunteers Receives: Procedure: Induced sputum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum OPG
Sputum OPG as assessed by ELISA at baseline
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2010
- Study completionMar 2010
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 Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergei A Kharitonov, MD PhD, Principal investigator, National Heart and Lung Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655954
- Sponsor's protocol ID
- 05-Q0407-91
- Status last verified
- Jul 2019
- First submitted
- 4 Apr 2008
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
To M, Ito K, Ausin PM, Kharitonov SA, Barnes PJ. Osteoprotegerin in sputum is a potential biomarker in COPD. Chest. 2011 Jul;140(1):76-83. doi: 10.1378/chest.10-1608. Epub 2010 Dec 2.
PubMed 21127170
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoprotegerin (OPG) in Induced Sputum as a Novel Biomarker for COPD
- ClinicalTrials.gov ID
- NCT00655954
- Acronym / sponsor ID
- 05-Q0407-91
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, asthma, smokers, healthy volunteers, bronchiectasis, cystic fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Apr 2008 (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.
Evaluation of OPG level as disease markers has also been reported. It has been showed that patients with coronary artery disease had higher serum OPG levels than healthy volunteers. Moreover, serum OPG levels correlate with the number of stenotic coronary arteries
Detailed description
Osteoprotegerin (OPG) is a secreted glycoprotein containing 401 amino acids. It is a member of the tumour necrosis factor (TNF) receptor superfamily. It was firstly discovered as a protein regulating bone metabolism, inhibiting osteoclastogenesis, consequently, inhibiting bone resorption OPG is detected in lung using Northern blot analysis. It is likely that OPG would contribute to the pathogenesis of COPD and could be an effective disease marker of the disease
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers non smoker | – | Procedure: Induced sputum18 volunteers |
| Healthy volunteers smoker | – | Procedure: Induced sputum15 volunteers |
| Chronic Obstructive Pulmonary Disease COPD | – | Procedure: Induced sputum39 volunteers |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were recruited from the outpatient department of Royal Brompton Hospital and local general practices. Patients with COPD were diagnosed using the GOLD (Global Initiative for Obstructive Lung Disease) criteria. 25 Patients with COPD who had an exacerbation during the last 2 months prior to the visit were excluded. Patients with asthma were diagnosed using the GINA (Global Initiative for Asthma) guidelines for asthma. 26 Patients with any other lung diseases were excluded from the study. This study was reviewed and approved by the Hounslow and Hillingdon Research Ethics Committee. Written informed consent was obtained from all subjects.
Key inclusion criteria (21 listed)
- Healthy non-smokers
- Healthy smokers
Key exclusion criteria (21 listed)
- Healthy non-smokers and smokers
- Bronchiectasis and cystic fibrosis
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 |
|---|---|---|
| Induced sputumUsed Ultrasonic nebuliser | Procedure or surgery | Chronic Obstructive Pulmonary Disease COPD, Healthy volunteers non smoker, Healthy volunteers smoker |
Primary outcome
Sputum OPG
Time frame: 1 hour
Sputum OPG as assessed by ELISA at baseline
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 10 Jul 2019.
- Results publication: PubMed 21127170To M, Ito K, Ausin PM, Kharitonov SA, Barnes PJ. Osteoprotegerin in sputum is a potential biomarker in COPD. Chest. 2011 Jul;140(1):76-83. doi: 10.1378/chest.10-1608. Epub 2010 Dec 2.
- Individual participant dataSharing planned: No
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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.
Sergei A Kharitonov, MD PhD principal investigator
National Heart and Lung Institute
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 Pulmonary Disease, Chronic Obstructive, run by Imperial College London at 1 site in United Kingdom.
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 21 inclusion and 21 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 10 Jul 2019. 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 United Kingdom. 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?
Sputum OPG (time frame: 1 hour). 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 NCT00655954, 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 10 Jul 2019.