Chronic Obstructive Pulmonary DiseaseNCT00555529
Systemic Endothelial Abnormalities in COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- radial artery applanation tonometry (RAAP)
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2006to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Smokers, COPD
Who may be able to join
- • 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
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- 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.
Who cannot join
- • 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Imperial College London
London, SW3 6LY
National Heart and Lung Institute
London, SW3 6LY
About this study
Official title: Systemic Endothelial Abnormalities in COPD Measured by Radial Artery Applanation Tonometry (RAAP)
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.
Read the detailed description
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- radial artery applanation tonometry (RAAP)
- Keywords
- COPD, exhaled breath condensate, applanation tonometry, induced sputum, smokers, healthy control
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radial artery applanation tonometry (RAAP)Procedure or surgery
non-invasive tonometry
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Procedure: radial artery applanation tonometry (RAAP) | |
| 2 | Not described Receives: Procedure: radial artery applanation tonometry (RAAP) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startJan 2006 (estimated)
- Primary completionNov 2008 (estimated)
- Study completionNov 2008 (estimated)
Why it stopped: Lead researcher left the Department
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergei A Kharitonov, MD PhD, Principal investigator, Imperial College LondonPeter J Barnes, MD, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555529
- Sponsor's protocol ID
- 9022006
- Status last verified
- Jul 2019
- First submitted
- 7 Nov 2007
- Last updated
- 10 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Endothelial Abnormalities in COPD Measured by Radial Artery Applanation Tonometry (RAAP)
- ClinicalTrials.gov ID
- NCT00555529
- Acronym / sponsor ID
- 9022006
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, exhaled breath condensate, applanation tonometry, induced sputum, smokers, healthy control
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lead researcher left the Department
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2006 (estimated)
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 8 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: radial artery applanation tonometry (RAAP) |
| 2 | – | Procedure: radial artery applanation tonometry (RAAP) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Smokers, COPD
Key inclusion criteria (9 listed)
- • 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)
- 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
Key exclusion criteria (6 listed)
- • As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radial artery applanation tonometry (RAAP)non-invasive tonometry | Procedure or surgery | 1, 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Imperial College LondonLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergei A Kharitonov, MD PhD principal investigator
Imperial College London
Peter J Barnes, MD study director
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Imperial College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.