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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00159341
Other study ID # 05/Q0404/84
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2005
Est. completion date December 2006

Study information

Verified date September 2023
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Nasal lavage
Nasal lavage was carried out at specified timepoints
Nasal filter paper
Nasal filter paper was placed at specified timepoints
Blood sampling
Blood sampling was performed as a routine safety check

Locations

Country Name City State
United Kingdom National Heart & Lung Institue Clinical Studies Unit, Imperial College London London

Sponsors (2)

Lead Sponsor Collaborator
Imperial College London Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

- Vachier I et al.Inflammatory features of nasal mucosa in smokers with and without COPD. Thorax 2004; 59:303-307. - Naclerio RM et al. Mediator release after nasal airway challenge with allergen. Am Rev Respir Dis 1983; 128:597-602. - Greiff L et al. The

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the cytology and inflammatory mediator content of nasal exudates Single timepoint
Secondary Comparison of nasal inflammatory response to smoke in patients with COPD with relevant controls Single timepoint
Secondary Comparison of inflammatory response in blood following cigarette smoking in patients with COPD and relevant controls Single timepoint
Secondary Comparison of nasal challenge with blood challenge Single timepoint
Secondary Develop a nasal challenge model to test novel anti-inflammatoy therapies for COPD Single timepoint
Secondary Identification of potential biomarkers for therapeutic trials in COPD Single timepoint
Secondary Definition of novel drug targets for potential new anti-inflammatory therapies Single timepoint
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