COPDNCT02490358
Biomarker Assay Validation in Healthy Smokers and COPD Smokers and Ex-smokers
An observational study of COPD and Asthma, run by Respivert Ltd at 1 site in United Kingdom.
Trial summary
This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers to analyse biomarkers of inflammation Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Jan 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 20 of each of the following populations will be recruited in this study: * Healthy smoking subjects * Smoking subjects with COPD * Ex-smoking subjects with COPD
Who may be able to join
- Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Be between 18 and 75 years of age, inclusive, at informed consent.
- Healthy as determined by a physician, based on medical history and physical examination.
- Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of ≥ 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked).
- Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Aged between 40 and 75 years of age inclusive, at the time of signing the informed consent.
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- COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli, 2004). Symptoms must be compatible with COPD for at least 1 year prior to screening and post-bronchodilator spirometry readings at screening:
- Post-bronchodilator FEV1/FVC ratio of <0.7
- Post-bronchodilator FEV ≥40 % and ≤80 % of predicted normal values calculated using NHANES reference equations.
- Additional Inclusion for Smoking COPD Subjects 1. Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of ≥ 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked).
- Exclusion Criteria for Healthy Smoking Subjects Any potential subject who meets any of the following criteria will be excluded from the participating study.
- Upper or lower respiratory tract infection within 4 weeks of the screening visit.
- Positive test for alcohol at screening.
- Taking prescription medication in the 14 days before screening.
- Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded include, but are not limited to pipes, cigars and e-cigarettes.
- Subjects who are unable to produce a total weight of at least 0.1 grams (g) of selected sputum at screening
- Urinary cotinine levels at screening < 30 ng/ml.
- Subject is mentally or legally incapacitated.
- Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO.
- Any other reason that the Investigator considers makes the subject unsuitable to participate.
- Exclusion Criteria for COPD Subjects Any potential subject who meets any of the following criteria will be excluded from the participating study
- Upper or lower respiratory tract infection within 4 weeks of the screening visit.
- Positive test for alcohol at screening.
- Subjects who are unable to produce a total weight of at least 0.1g of selected sputum at screening.
- Subject is mentally or legally incapacitated.
- Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO.
- Any other reason that the Investigator considers makes the subject unsuitable to participate.
- A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
- Taking theophylline in the 28 days before screening
- Change in COPD medication in the 28 days before screening
- Taking oral steroids in the 28 days before screening
- Additional Exclusion Criterion for Smoking COPD Subjects
- Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded include, but are not limited to pipes, cigars and e-cigarettes.
- Urinary cotinine levels at screening < 30 ng/ml.
- Additional Exclusion Criterion for Ex-Smoking COPD Subjects
- 1. The subject is a smoker (regular or irregular), or has smoked or used nicotine-containing products within the 6 months prior to screening.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Sputum Sample Collection Protocol for Biomarker Assay Validation in Healthy Smokers and COPD Smokers and Ex-Smokers
This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers to analyse biomarkers of inflammation
- 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 |
|---|---|---|
| 1 | Healthy smoking subjects | |
| 2 | COPD smoking subjects | |
| 3 | COPD ex-smoker subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid metabolites in sputum cell homogenate from healthy smokers and smokers and ex-smokers with COPD.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivert Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Babraham Institute Enterprise Limited
- Responsible party
- Sponsor
- Investigators
- Ginny Norris, Dr, Study director, Respivert Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490358
- Sponsor's protocol ID
- ENA003
- Status last verified
- Feb 2016
- First submitted
- 26 May 2015
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sputum Sample Collection Protocol for Biomarker Assay Validation in Healthy Smokers and COPD Smokers and Ex-Smokers
- ClinicalTrials.gov ID
- NCT02490358
- Acronym / sponsor ID
- ENA003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Respivert LtdIndustry (pharma, biotech, devices)
- Collaborators
- Babraham Institute Enterprise Limited
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Jul 2015 (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.
This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers to analyse biomarkers of inflammation
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy smoking subjects |
| 2 | – | –COPD smoking subjects |
| 3 | – | –COPD ex-smoker subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 20 of each of the following populations will be recruited in this study: * Healthy smoking subjects * Smoking subjects with COPD * Ex-smoking subjects with COPD
Key inclusion criteria (36 listed)
- Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Be between 18 and 75 years of age, inclusive, at informed consent.
- Healthy as determined by a physician, based on medical history and physical examination.
- Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of ≥ 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked).
- Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Key exclusion criteria (0 listed)
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
Lipid metabolites in sputum cell homogenate from healthy smokers and smokers and ex-smokers with COPD.
Time frame: 8 months
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 3 Feb 2016.
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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.
Ginny Norris, Dr study director
Respivert Ltd
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 COPD and Asthma, run by Respivert Ltd 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 36 inclusion and 0 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 3 Feb 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 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?
Lipid metabolites in sputum cell homogenate from healthy smokers and smokers and ex-smokers with COPD. (time frame: 8 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 3 Feb 2016.