Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Imperial College London Millennium Pharmaceuticals, Inc. |
---|---|
Information provided by: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00159341 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Diseases, Obstructive |
Procedure: Nasal lavage Procedure: Nasal filter paper Procedure: Blood sampling |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Bio-equivalence Study |
Official Title: | Cigarette Smoke Nasal and Whole Blood Challenge in Patients With COPD |
Enrollment: | 16 |
Study Start Date: | September 2005 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria (COPD Smokers):
Exclusion criteria (COPD Smokers):
Inclusion criteria (for "Healthy" Smokers):
Exclusion criteria (for "Healthy" Smokers):
United Kingdom | |
National Heart & Lung Institue Clinical Studies Unit, Imperial College London | |
London, United Kingdom, SW3 6HP |
Principal Investigator: | Trevor T Hansel, BSc MSc PhD | National Heart & Lung Institute, Imperial College London |
Responsible Party: | NHLI Clinical Studies Unit ( Dr Trevor Hansel ) |
Study ID Numbers: | 05/Q0404/84 |
Study First Received: | September 8, 2005 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00159341 |
Health Authority: | United Kingdom: Research Ethics Committee |
cigarette smoke nasal whole blood cytokines |
chemokines nasal fluid filter paper |
Smoking Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Pulmonary Disease, Chronic Obstructive |