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Clinical Trials/NCT00159289
NCT00159289WithdrawnNot Applicable

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

Imperial College London1 site in 1 countryStarted: June 1, 2003Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
sputum induced
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
21 Years to 75 Years (Adult, Older Adult)
Sex
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

  • •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

Arms & Interventions

1

Experimental

Inhalation of LPS

Intervention: Inhalation of LPS (Procedure)

2

Placebo Comparator

PLacebo

Intervention: Placebo (Procedure)

Outcomes

Primary Outcomes

sputum induced

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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