Systemic Endothelial Abnormalities in COPD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Imperial College London.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00555529
First received: November 7, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose
  • The purpose of this project is to validate the peripheral arterial pressure waveform measurements technique of RAAP (radial artery applanation tonometry), in patients with moderate and severe COPD (Chronic Obstructive Pulmonary Disease), and to assess the degree of systemic endothelial dysfunction in these patients compared to cigarette smokers with normal lung function and non-smokers with normal lung function.
  • Patients with moderate and severe COPD (GOLD stage II and III) will be studied and their results will be compared with age-matched healthy non- smokers and smokers.
  • RAAP will be taken every 5 minutes for 15 minutes before salbutamol and every 5 minutes for another 15 minutes after salbutamol.
  • Several parameters of lipoprotein profiles, anti-oxidant plasma capacity, inflammatory cytokines, hormones, growth factors and vascular cell adhesion molecules will be studied in blood. In addition, several inflammatory and oxidative markers will be studied in exhaled breath condensate. Lung function and impulse oscillometry will be made to investigate airway resistance, and exhaled NO (nitric oxide) at different expiratory flows will be measured to assess alveolar and bronchial NO. Clinical assessment including dyspnoea and depression scores will also be made.

Condition Intervention
Chronic Obstructive Pulmonary Disease
Procedure: radial artery applanation tonometry (RAAP)

Study Type: Observational
Official Title: Systemic Endothelial Abnormalities in COPD Measured by Radial Artery Applanation Tonometry (RAAP)

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Estimated Enrollment: 36
Study Start Date: January 2006
Estimated Study Completion Date: November 2008
Groups/Cohorts Assigned Interventions
1 Procedure: radial artery applanation tonometry (RAAP)
non-invasive tonometry
2 Procedure: radial artery applanation tonometry (RAAP)
non-invasive tonometry

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Smokers, COPD

Criteria

Inclusion Criteria:

  • • Male subjects with COPD with FEV1/FVC<70%; predicted defined as either stage moderate GOLD II (n=15) and severe GOLD III (n=7) diagnosis according to GOLD criteria (Global Strategy for the Diagnosis, Management, and Prevention of COPD) or Male subjects who are age-matched non-smokers (n=8) and male smokers (n=8) with normal lung function (FEV1>80%, FEV1/FVC>70%, n=8)

    • Smokers:

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]. Smokers need to report the time when last cigarette was smoked (no less than 6 hours before the study visit).

  • Patients will be allowed to use their current anticholinergic bronchodilators and continue on the dose of inhaled corticosteroids they are currently using. However they should refrain from short and long-acting β2-agonists for 6 and 12 hours, respectively, before the study visit.
  • Aged 40 80 years inclusive
  • Body mass index within the range 19-32kg/m2 inclusive
  • FEV1 <15% reversibility (not % predicted) and an increase of <200ml after inhaled β2-agonists (400μg salbutamol).
  • Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Subject is available to complete the study.

Exclusion Criteria:

  • • 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 3 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 2 week washout will be sufficient
    • The subject regularly, or on average, drinks more than 21 units of alcohol per week.
    • The subject has received oral steroids within 2 weeks prior to study entry.
    • The subject has history of an upper respiratory infection (including sinusitis) within 2 weeks prior to study entry
    • The subject has been hospitalised for a COPD exacerbation within 1 month of study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555529

Locations
United Kingdom
Imperial College London
London, United Kingdom, SW3 6LY
National Heart and Lung Institute
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Sergei A Kharitonov, MD PhD Imperial College London
Study Director: Peter J Barnes, MD Imperial College London
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00555529     History of Changes
Other Study ID Numbers: 9022006
Study First Received: November 7, 2007
Last Updated: November 7, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
COPD
exhaled breath condensate
applanation tonometry
induced sputum
smokers
healthy control

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014