CClinicalTrials.gg
Sign In
WithdrawnNCT00159289Updated Apr 4, 2024

Endotoxin and Inflammatory Markers in Healthy Non-Smokers and Current Smokers Including Patients With Chronic Obstructive Pulmonary Disease (COPD)

An interventional study of Inhalation of LPS and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Imperial College London. Withdrawn at 1 site in United Kingdom. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Imperial College London · Not applicable, Interventional, and Other

Why this study was withdrawn
No resources available

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Jun 2003, registered Sep 2005).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

Study 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 non-smokers and current smokers, including patients with chronic obstructive pulmonary disease (COPD).

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Mild to moderate Chronic Obstructive Pulmonary Disease (COPD)
  • Volunteers (healthy non-smokers)
  • Volunteers (current or ex-smokers)
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

Browse Lung Diseases studies →

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    Inhalation of LPS

    Procedure: Inhalation of LPS

  • Placebo comparator
    2

    PLacebo

    Procedure: Placebo

Interventions

  • ProcedureInhalation of LPS
  • ProcedurePlacebo
06

What researchers measure

Primary outcomes

  1. sputum induced

07

Study locations

1 site
  • Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
    London, SW3 6LY, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00159289
Lead sponsor
Imperial College London
First posted
Sep 12, 2005
Start date
Jun 2003
Primary completion
Jun 2003
Completion
Jun 2003
Last update
Apr 4, 2024

Study contacts

Sergei A Kharitonov, MD, PhD
principal investigator · Imperial College London
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lung Diseases→

Other studies from this sponsor

Imperial College London

Start the discussion