Chronic Obstructive Pulmonary DiseaseNCT00159289
Endotoxin and Inflammatory Markers in Healthy Non-Smokers and Current Smokers Including Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Inhalation of LPS in people with Chronic Obstructive Pulmonary Disease, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The primary aim of this study is to investigate the effects of inhaled lipopolysaccharide endotoxin (LPS) on bronchial and alveolar exhaled nitric oxide (NO) and NO metabolites and other inflammatory markers and mediators in exhaled breath condensate, induced sputum, nasal lavage and mouthwash fluid in healthy… Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inhalation of LPS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2003to Jun 2003
- Phase
- Interventional
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy non-smokers: normal spirometry (forced expiratory volume in 1 second [FEV1] more than or equal to 90% predicted) and normal exhaled NO (between 8 and 24 ppb; flow 50 ml/s)
- 0: At risk (current or ex-smokers): normal spirometry, with or without chronic symptoms (cough, sputum production)
- I-II: Mild-moderate COPD
- FEV1 reversibility of < 15% after inhaled beta2-agonists
- FEV1/forced vital capacity (FVC) < 70% predicted
- FEV1 between greater than or equal to 50% and less than 80%
- With or without chronic symptoms (cough, sputum production)
- Able to comprehend and grant a written informed consent
Who cannot join
- Concomitant use or pre-treatment within the last 4 weeks with oral steroids
- Respiratory infection within 4 weeks prior to entry into the trial
- Females who are pregnant or lactating
- History of current or past drug or alcohol abuse
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: Effect of Endotoxin on Inflammatory Markers in Exhaled Breath, Sputum, Saliva and Nasal Lavage in Healthy Non-Smokers and Current Smokers Including Patients With COPD
The primary aim of this study is to investigate the effects of inhaled lipopolysaccharide endotoxin (LPS) on bronchial and alveolar exhaled nitric oxide (NO) and NO metabolites and other inflammatory markers and mediators in exhaled breath condensate, induced sputum, nasal lavage and mouthwash fluid in healthy non-smokers and current smokers, including patients with chronic obstructive pulmonary disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inhalation of LPS, Placebo
- Keywords
- Mild to moderate Chronic Obstructive Pulmonary Disease (COPD), Volunteers (healthy non-smokers), Volunteers (current or ex-smokers)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation of LPSProcedure or surgery
PlaceboProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Inhalation of LPS Receives: Procedure: Inhalation of LPS |
| 2 | Placebo comparator | PLacebo Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sputum induced
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJun 2003
- Study completionJun 2003
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 Chronic Obstructive Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Investigators
- Sergei A Kharitonov, MD, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159289
- Sponsor's protocol ID
- 2002AT032B
- Status last verified
- Apr 2024
- First submitted
- 8 Sep 2005
- Last updated
- 4 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endotoxin on Inflammatory Markers in Exhaled Breath, Sputum, Saliva and Nasal Lavage in Healthy Non-Smokers and Current Smokers Including Patients With COPD
- ClinicalTrials.gov ID
- NCT00159289
- Acronym / sponsor ID
- 2002AT032B
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Mild to moderate Chronic Obstructive Pulmonary Disease (COPD), Volunteers (healthy non-smokers), Volunteers (current or ex-smokers)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No resources available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2003 (actual)
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 12 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 investigate the effects of inhaled lipopolysaccharide endotoxin (LPS) on bronchial and alveolar exhaled nitric oxide (NO) and NO metabolites and other inflammatory markers and mediators in exhaled breath condensate, induced sputum, nasal lavage and mouthwash fluid in healthy non-smokers and current smokers, including patients with chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Inhalation of LPSInhalation of LPS |
| 2 | Placebo comparator | Procedure: PlaceboPLacebo |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy non-smokers: normal spirometry (forced expiratory volume in 1 second [FEV1] more than or equal to 90% predicted) and normal exhaled NO (between 8 and 24 ppb; flow 50 ml/s)
- 0: At risk (current or ex-smokers): normal spirometry, with or without chronic symptoms (cough, sputum production)
- I-II: Mild-moderate COPD
- Able to comprehend and grant a written informed consent
Key exclusion criteria (4 listed)
- Concomitant use or pre-treatment within the last 4 weeks with oral steroids
- Respiratory infection within 4 weeks prior to entry into the trial
- Females who are pregnant or lactating
- History of current or past drug or alcohol abuse
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 |
|---|---|---|
| Inhalation of LPS | Procedure or surgery | 1 |
| Placebo | Procedure or surgery | 2 |
Primary outcome
sputum induced
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 4 Apr 2024.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhalation of LPS in people with Chronic Obstructive Pulmonary Disease, 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 8 inclusion and 4 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 4 Apr 2024. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
sputum induced. 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 4 Apr 2024.