![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Imperial College London GlaxoSmithKline |
---|---|
Information provided by: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00159302 |
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.
In 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.
Condition | Intervention |
---|---|
Healthy Smokers Healthy Non-Smokers Patients With Mild Asthma Patints With COPD (GOLD II) |
Procedure: Induced Sputum Procedure: Exhaled Nitric Oxide Procedure: Nasal Nitric Oxide Procedure: Blood Tests Procedure: 24hr Urine Samples Procedure: Exhaled Breath Condensate Procedure: Spirometry |
Study Type: | Observational |
Study Design: | Cross-Sectional, Defined Population, Prospective Study |
Official Title: | A Pilot Study to Evaluate and Develop Biomarkers of iNOS Activity in Patients With COPD or Asthma and Healthy Volunteers |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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:
9. 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:
United Kingdom | |
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital | |
London, United Kingdom, SW3 6LY |
Principal Investigator: | Sergei A Kharitonov, MD PhD | Imperial College London |
Study ID Numbers: | RES11115 |
Study First Received: | September 8, 2005 |
Last Updated: | September 8, 2005 |
ClinicalTrials.gov Identifier: | NCT00159302 |
Health Authority: | United Kingdom: Research Ethics Committee |
Nitric Oxide Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Healthy Respiratory Hypersensitivity Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Bronchial Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents |
Cardiovascular Agents Protective Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Peripheral Nervous System Agents Bronchodilator Agents |