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Cigarette Smoke Nasal and Whole Blood Challenge in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00159341 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-09-14

No results posted yet for this study

Summary

This is a clinical research study to assess whether after exhaling a single cigarette smoke through the nose there are changes in the inflammatory cells and proteins of nasal secretions.

A single blood sample from each subject will be stimulated with cigarette smoke in the laboratory to see the effects on inflammatory blood cells.

Comparison of findings between smokers with COPD and "Healthy" smokers will be carried out.

We hypothesize that some subjects have amplified inflammatory response to a single cigarette, and these will be those subjects who develop chronic obstructive pulmonary disease (COPD) after decades of smoking. We hope to develop an acute challenge model that relates to the causation of COPD. When studying the effects of new drugs, these may be detected in small numbers of patients in a challenge situation, when we would need to study many more unchallenged patients to demonstrate drug effects. In clinical research on asthma and allergy, the nasal allergen challenge has been a very successful model, and we hope to validate a comparable model for COPD.

Conditions

  • Lung Diseases, Obstructive

Interventions

PROCEDURE

Nasal lavage

Nasal lavage was carried out at specified timepoints

PROCEDURE

Nasal filter paper

Nasal filter paper was placed at specified timepoints

PROCEDURE

Blood sampling

Blood sampling was performed as a routine safety check

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Imperial College London

    lead OTHER

Principal Investigators

  • Trevor T Hansel, BSc MSc PhD · National Heart & Lung Institute, Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00159341 on ClinicalTrials.gov