A Pilot Study to Evaluate and Develop Biomarkers of iNOS Activity in Patients With COPD or Asthma and Healthy Volunteers

Imperial College London1 site in 1 countrySeptember 2003

ConditionsHealthy Smokers Healthy Non-smokers Patients With Mild Asthma Patints With COPD (GOLD II)

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy Smokers
Sponsor: Imperial College London
Locations: 1
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

September 2006

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Imperial College London

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy volunteers (smokers)
•Healthy subjects, defined as individuals who are free from significant cardiac, pulmonary, 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.
•Subject has a screening FEV1 measurement of \> 80% of predicted
•Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
•Smokers with a pack history \>10 pack years \[number of pack years = (number of cigarettes per day / 20) x number of years smoked\].
•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.

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:
•As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
•The subject has participated in a study with a new molecular entity during the previous 4 months or any other clinical trial during the previous 3 months. In case of a non invasive, clinical trial not involving new molecular entities a 1 month washout will be sufficient.
•The subject has donated a unit of blood within the previous month or intends to donate in the month after completing the study
•The subject regularly, or on average, drinks more than 21 units per week
•The subjects is taking any medication (whether prescribed or over-the-counter), any herbal medication (incl. St.John's Wort) or high doses of nutritional supplements which could interfere with the study tests, within 14 days of study entry and throughout the study.
•The subject has received oral steroids within 3 months of study entry
•The subject significant risk factors for Hepatitis B or C infection
•The subject has significant risk factors for HIV infection.