Chronic Obstructive Pulmonary Disease / Healthy Smokers / Healthy Non-Smokers Respiratory Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Group 1: ?Smokers with moderate COPD
Group 2: ?Smokers with no evidence of COPD
Group 3: ?Non smokers (have never smoked, other than on an occasional basis and no cigarettes in the last year)
During
Sponsors
Sunovion Pharmaceuticals Europe Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All subjects (males and females) will be in relatively good health aged >=40 and <=80 years 2. Specific inclusion criteria apply for each Group of subjects i.e Groups 1-3, with emphasis on the degree of lung function 2.1. COPD (Group 1): In addition to the general inclusion criteria, Smokers with COPD must also have a documented history of moderate COPD (GOLD Stage 2) and be clinically stable and free from an acute exacerbation of COPD for 8 weeks prior to Study Day 1. 2.2. Healthy Smokers Without Evidence of COPD (Group 2): Healthy smokers without evidence of COPD, in addition to the general inclusion criteria, must also Smoke = 5 cigarettes per day and have a =10 pack year smoking history. Other criteria apply. 2.3. Non-smoking Healthy Subjects (Group 3): Healthy non-smokers without evidence of COPD, in addition to the general inclusion criteria must never smoked (other than on an occasional basis and no cigarettes in the last year). 3. Subjects must be able to comply with all aspects of the protocol and able to give written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. All subjects will not have, or have had a history of, clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, metabolic, endocrine, haematological or other major disorders 2. They will not have, or have had a history of, drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To develop a novel cigarette challenge in vivo model incorporating full network biology analysis of transcriptomic, metabolomic and cytokine/chemokine changes in the nose and blood of smokers with the Global Initiative for Chronic Obstructive Lung Disease (GOLD, www.goldcopd.org) Stage 2 COPD, healthy smokers with normal lung function and non-smokers, post cigarette smoking challenge or sham/ dummy cigarette challenge (as applicable). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To stimulate blood ex vivo from all groups to follow-up and validate the observations of the primary objective 2. To identify molecular biomarkers for COPD patients 3. To develop a cigarette smoking challenge model in COPD patients | — |
Countries
United Kingdom
Outcome results
None listed