Cigarette Smoke Nasal and Whole Blood Challenge in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.
Lung Diseases, Obstructive
Procedure: Nasal lavage
Procedure: Nasal filter paper
Procedure: Blood sampling
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Cigarette Smoke Nasal and Whole Blood Challenge in Patients With COPD|
- Changes in the cytology and inflammatory mediator content of nasal exudates [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]
- Comparison of nasal inflammatory response to smoke in patients with COPD with relevant controls [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]
- Comparison of inflammatory response in blood following cigarette smoking in patients with COPD and relevant controls [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]
- Comparison of nasal challenge with blood challenge [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]
- Develop a nasal challenge model to test novel anti-inflammatoy therapies for COPD [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]
- Identification of potential biomarkers for therapeutic trials in COPD [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]
- Definition of novel drug targets for potential new anti-inflammatory therapies [ Time Frame: Single timepoint ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Procedure: Nasal lavage
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159341
|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|