Status:
COMPLETED
Cigarette Smoke Nasal and Whole Blood Challenge in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Lung Diseases, Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
Brief 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 blo...
Detailed Description
Introduction Chronic obstructive pulmonary disease (COPD) is a common respiratory disease that causes widespread morbidity and mortality, the Global Burden of Disease Study estimating COPD to be curre...
Eligibility Criteria
Inclusion
- Inclusion Criteria (COPD Smokers):
- Smokers currently on at least 5 cigarettes per day, with a history of \>10 pack years
- Post-bronchodilator FEV1 \>30% of predicted and \< 80% of predicted
- Pre-bronchodilator FEV1/FVC of \<70%
- With or without chronic simple bronchitis
- Exclusion criteria (COPD Smokers):
- History of asthma, allergy (including rhinitis/eczema)
- Reversibility : an increase in FEV1 that is \>400ml from the baseline pre- bronchodilator value (bronchodilate with salbutamol 400g delivered from a metered dose inhaler (MDI) into a spacer).
- Inclusion criteria (for "Healthy" Smokers):
- Smokers currently on at least 5 cigarettes per day, with a history of \>10 pack years
- FEV1 \>90% of predicted, FEV1/FVC of \>70%
- Cannot have chronic simple bronchitis
- Age, sex, smoking history matched to COPD Smokers
- Exclusion criteria (for "Healthy" Smokers):
- History of asthma, allergy (including rhinitis/eczema
- Reversibility: an increase in FEV1 that is both \>400ml from the baseline pre-bronchodilator value (bronchodilate with salbutamol 400mcg delivered from a metered dose inhaler (MDI) into a spacer)P
- Pregnancy
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00159341
Start Date
September 1 2005
End Date
December 1 2006
Last Update
September 14 2023
Active Locations (1)
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1
National Heart & Lung Institue Clinical Studies Unit, Imperial College London
London, United Kingdom, SW3 6HP