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

NCT ID: NCT00159289

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2003-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Inhalation of LPS

Group Type EXPERIMENTAL

Inhalation of LPS

Intervention Type PROCEDURE

2

PLacebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

Interventions

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Inhalation of LPS

Intervention Type PROCEDURE

Placebo

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Principal Investigators

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Sergei A Kharitonov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2002AT032B

Identifier Type: -

Identifier Source: org_study_id

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