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This pilot study will measure the baseline levels and the intra- and inter-subject variability of exhaled (alveolar and bronchial) and nasal NO in smoking subjects with mild and moderate COPD on or off steroid treatment, smoking healthy volunteers and non-smoking mild asthmatics off steroids, using multiple exhalation flow rates.
I
Full description
n addition, exploratory markers of iNOS activity (eg. 3-nitrotyrosine, nitrite, nitrate and 3-nitro-4-hydoxyphenylacetic acid) in blood, sputum, urine and exhaled breath condensate will be evaluated. We will also evaluate exhaled and nasal NO in a population of mild asthmatics in order to obtain baseline and variability data for future clinical studies involving asthmatic subjects.
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Inclusion criteria
Healthy volunteers (smokers)
A smoking COPD subject will be eligible for inclusion in this study only if all of the following criteria apply:
COPD patients, defined as either Stage I or Stage II COPD diagnosis according to GOLD criteria Individuals must be otherwise healthy, individuals who are free from significant cardiac, gastrointestinal, hepatic, renal, haematological, malignancy, endocrine, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
Aged 40-75 years inclusive.
Male or female
Body mass index within the range 19-32kg/m2 inclusive.
FEV1/FVC < 70%
FEV1 <15% reversibility (not % predicted) or an increase of <200ml (or both) after inhaled B2-agonists (400mcg salbutamol)
Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
An active smoker with a pack history of >10 pack years [number of pack years = (number of cigarettes per day / 20) x number of years smoked].
Asthma (non-smokers)
Exclusion criteria
Healthy volunteers (smokers)
A healthy smoking subject will not be eligible for inclusion in this study if any of the following criteria apply:
COPD (smokers)
A smoking COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
A non smoking asthmatic subject will not be eligible for inclusion in this study if any of the following criteria apply:
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Data sourced from clinicaltrials.gov
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