Healthy Non-smokersNCT00180622
Markers for Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Healthy Non-smokers and Current Smokers, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The primary aim of this study is to exploit a difference between COPD patients, chronic smokers without COPD and healthy non-smoking subjects. This will help to assess the utility of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the lung function, clinical parameters and… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Non-smokers, Current Smokers, COPD Patients
- What is being tested?
- Spirometry, Exhaled Nitric Oxide and Carbon Monoxide and Exhaled Breath Condensate
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2001to 1 Jul 2002
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy non-smokers
- FEV1 >80% predicted
- FEV1 reversibility of <10% after inhaled (beta2-agonists
- Current smokers
- FEV1 no less than 80% predicted
- FEV1 reversibility of <10% after inhaled (beta2-agonists
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- Smoking history of > 10 pack-years
- Moderate COPD
- FEV1 40-59% predicted
- FEV1 reversibility of <10% after inhaled (beta2-agonists
- Smoking history of > 10 pack-years**
- Severe COPD
- FEV1 <40% predicted
- FEV1 reversibility of <10% after inhaled (beta2-agonists
- Smoking history of > 10 pack-years
Who cannot join
- FEV1 increases by 200 ml and 15% of the baseline value after inhaled (beta2-agonists
- Asthma
- unstable disease (FEV1 <35% predicted) and/or current, or within the last 4 weeks, respiratory tract infection.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, SW3 6LY
About this study
Official title: Non-Invasive Markers for Chronic Obstructive Pulmonary Disease (COPD)
The primary aim of this study is to exploit a difference between COPD patients, chronic smokers without COPD and healthy non-smoking subjects. This will help to assess the utility of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the lung function, clinical parameters and computerised tomography (CT).
- Conditions
- Healthy Non-smokers, Current Smokers, COPD Patients
- Being tested
- Spirometry, Exhaled Nitric Oxide and Carbon Monoxide, Exhaled Breath Condensate, Induced Sputum, CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryProcedure or surgery
Exhaled Nitric Oxide and Carbon MonoxideProcedure or surgery
Exhaled Breath CondensateProcedure or surgery
Induced SputumProcedure or surgery
CT ScanProcedure or surgery
Blood testProcedure or surgery
St Georges QuestionnaireProcedure or surgery
BodypletysmographyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start1 Jul 2001 (estimated)
- Primary completion1 Jul 2002 (estimated)
- Study completion1 Jul 2002 (estimated)
Why it stopped: No resources available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Non-smokersStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Sergei A Kharitonov, MD PhD, Principal investigator, Imperial College LondonPeter J Barnes, MA DM DSc FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180622
- Sponsor's protocol ID
- SD-000-068
- Status last verified
- Jul 2019
- First submitted
- 9 Sep 2005
- Last updated
- 5 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Markers for Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00180622
- Acronym / sponsor ID
- SD-000-068
- Conditions
- Healthy Non-smokers, Current Smokers, COPD Patients
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No resources available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Jul 2001 (estimated)
- Primary completion
- 1 Jul 2002 (estimated)
- Study completion
- 1 Jul 2002 (estimated)
- First posted
- 16 Sep 2005 (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 primary aim of this study is to exploit a difference between COPD patients, chronic smokers without COPD and healthy non-smoking subjects. This will help to assess the utility of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the lung function, clinical parameters and computerised tomography (CT).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy non-smokers
- FEV1 >80% predicted
- FEV1 reversibility of <10% after inhaled (beta2-agonists
- Current smokers
- FEV1 no less than 80% predicted
Key exclusion criteria (3 listed)
- FEV1 increases by 200 ml and 15% of the baseline value after inhaled (beta2-agonists
- Asthma
- unstable disease (FEV1 <35% predicted) and/or current, or within the last 4 weeks, respiratory tract infection.
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 |
|---|---|---|
| Spirometry | Procedure or surgery | – |
| Exhaled Nitric Oxide and Carbon Monoxide | Procedure or surgery | – |
| Exhaled Breath Condensate | Procedure or surgery | – |
| Induced Sputum | Procedure or surgery | – |
| CT Scan | Procedure or surgery | – |
| Blood test | Procedure or surgery | – |
| St Georges Questionnaire | Procedure or surgery | – |
| Bodypletysmography | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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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
Imperial College London
Peter J Barnes, MA DM DSc FRCP principal investigator
Imperial College London
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 Healthy Non-smokers and Current Smokers, 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 15 inclusion and 3 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: withdrawn, as of the sponsor's last update on 5 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 was withdrawn before enrolling participants, so there are no results.
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.
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 5 Jul 2019.