Cigarette Smoke Nasal and Whole Blood Challenge in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT00159341|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 15, 2008
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 or disease||Intervention/treatment||Phase|
|Lung Diseases, Obstructive||Procedure: Nasal lavage Procedure: Nasal filter paper Procedure: Blood sampling||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cigarette Smoke Nasal and Whole Blood Challenge in Patients With COPD|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
- 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
- Changes in the cytology and inflammatory mediator content of nasal exudates [ Time Frame: Single timepoint ]
- Comparison of nasal inflammatory response to smoke in patients with COPD with relevant controls [ Time Frame: Single timepoint ]
- Comparison of inflammatory response in blood following cigarette smoking in patients with COPD and relevant controls [ Time Frame: Single timepoint ]
- Comparison of nasal challenge with blood challenge [ Time Frame: Single timepoint ]
- Develop a nasal challenge model to test novel anti-inflammatoy therapies for COPD [ Time Frame: Single timepoint ]
- Identification of potential biomarkers for therapeutic trials in COPD [ Time Frame: Single timepoint ]
- Definition of novel drug targets for potential new anti-inflammatory therapies [ Time Frame: Single timepoint ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|