Chronic Obstructive Pulmonary DiseasePhase 4NCT01151306
The Effect of Statins in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Simvastatin and Lactose tablet in people with Chronic Obstructive Pulmonary Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a condition of the lungs which results in breathing difficulties due to the lungs becoming inflamed and the airways narrowed. Current treatments have focused on opening up the narrowed airways but, in addition, we know there is increased inflammation in the blood and… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Simvastatin and Lactose tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Aug 2013
- Phase
- Phase 4
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 45-80 years;
- Confirmed COPD: FEV1 30-80% predicted, FEV1/FVC<0.7, salbutamol reversibility <12%, supportive smoking history
- If female of childbearing potential, have a negative serum pregnancy test at screening and use a medically acceptable form of contraception starting at screening and continuing throughout the study (defined as an oral contraceptive, or barrier method combined with a spermicide)
- Able to attend for regular clinic appointments
- In opinion of investigator, the patient will be able to comply with the requirements of the protocol
- Provide written informed consent.
Who cannot join
- Known hypersensitivity to or side effects relating to previous statin treatment, or current therapy which includes a statin, ezetimibe or fibrate
- Clinically significant liver function abnormality; alcohol excess
- Hypercholesterolaemia > or equal to 6.5mmol/L
- Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
- Any condition judged by investigator that would cause the study to be detrimental to patient.
- Conditions: rheumatoid disease/other collagen vascular disease requiring therapy; diabetes mellitus; untreated hypothyroidism; inflammatory bowel disease; other respiratory disease; known alpha 1 antitrypsin deficiency; malignancy; documented history of ischaemic heart disease (IHD); cor pulmonale or known congestive heart failure; patients planning to undergo elective surgery during the study period.
Show all 10Show fewer
- Exacerbation in the last 4 weeks.
- Significant hypoxia (PaO2 <7.3kPa)
- Known lactose intolerance.
- Therapies: oral prednisolone for more than 1 week in the last 6 months; disease modifying drugs (Gold/ sulphasalazine etc); weight losing drugs; concomitant use of warfarin, cyclosporine; concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone). Use of any investigational drug within four weeks of the baseline visit.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Respiratory Biomedical Research Unit
Nottingham, NG5 1PB
About this study
Official title: The Cardiovascular and Inflammatory Effects of Statin Therapy in Patients With COPD
Chronic obstructive pulmonary disease (COPD) is a condition of the lungs which results in breathing difficulties due to the lungs becoming inflamed and the airways narrowed. Current treatments have focused on opening up the narrowed airways but, in addition, we know there is increased inflammation in the blood and these patients are at increased risk of heart disease. Statins, simvastatin being one of them, are drugs used to lower cholesterol in the blood but may also reduce inflammation and lower the risk of heart disease. This study will explore whether simvastatin reduces one of the risk factors in patients with COPD in a short term proof of principle study. The key purpose is to determine whether simvastatin improves the pressure and stiffness of the main blood vessels namely the arterial stiffness measure of aortic pulse wave velocity (PWV). In parallel, we will describe changes in airways and / or blood inflammation and change in breathing ability
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Simvastatin, Lactose tablet
- 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.
SimvastatinDrug
Simvastatin 20mg once daily (in the evening) for 6 weeks
Lactose tabletDrug
One tablet taken each evening for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lactose tablet | Placebo comparator | Not described Receives: Drug: Lactose tablet |
| Simvastatin 20mg | Active comparator | Not described Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial stiffness as measured by aortic pulse wave velocity (PWV) over study period
Aortic Pulse wave velocity (Sphygmocor, Atcor)
Measured: Week 0 (start) and week 6 (end)
Secondary outcomes (14)
Change in Circulating Inflammatory Mediators over study period
Measured: Week 0 (Start) and week 6 (End)
Change in distance (metres)walked on 6 minute walking test
together with pre- and post-walk oxygen saturations
Measured: week 0 (start) and week 6 (end)
Change in blood total cholesterol, triglycerides, HDL and LDL over study period
Measured: week 0 (Start) and week 6 (End)
Change in airway inflammatory markers (differential cell count, exhaled nitric oxide and airway cytokines) over study period
Measured: week 0 and week 6
Change in lung function: Spirometry - forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
Measured: week 0 (Start) and week 6 (End)
Change on blood pressure over study period
Measured: Week 0 (start) and Week 6 (end)
Change in Liver function tests
Measured: Week 0 (start) and Week 6 (End)
Change in creatine phosphokinase (CPK) over study period
Measured: Week 0 (start) and Week 6(End)
Change in Handgrip strength over study period
Measured: Week 0 (start) and Week 6 (end)
Change in blood desmosine over study period
Measured: Week 0 (Start) and Week 6 (end)
Change in circulating matrix metalloproteinase over study period
Measured: Week 0 (start) and Week 6 (end)
Baseline arterial stiffness (aortic pulse wave velocity)
Measured: Week 0
Baseline airway (differential cell count, exhaled nitric oxide and cytokines)and circulating inflammatory status (cytokines)
Measured: Week 0
Baseline matrix metalloproteinase in airway and blood
Measured: Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151306
- Sponsor's protocol ID
- 09105
- Status last verified
- Mar 2014
- First submitted
- 21 Jun 2010
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
John ME, Cockcroft JR, McKeever TM, Coward WR, Shale DJ, Johnson SR, Thornton JG, Harrison TW, Knox AJ, Bolton CE. Cardiovascular and inflammatory effects of simvastatin therapy in patients with COPD: a randomized controlled trial. Int J Chron Obstruct Pulmon Dis. 2015 Jan 29;10:211-21. doi: 10.2147/COPD.S76061. eCollection 2015.
PubMed 25673981
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiovascular and Inflammatory Effects of Statin Therapy in Patients With COPD
- ClinicalTrials.gov ID
- NCT01151306
- Acronym / sponsor ID
- 09105
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 28 Jun 2010 (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.
Chronic obstructive pulmonary disease (COPD) is a condition of the lungs which results in breathing difficulties due to the lungs becoming inflamed and the airways narrowed. Current treatments have focused on opening up the narrowed airways but, in addition, we know there is increased inflammation in the blood and these patients are at increased risk of heart disease. Statins, simvastatin being one of them, are drugs used to lower cholesterol in the blood but may also reduce inflammation and lower the risk of heart disease. This study will explore whether simvastatin reduces one of the risk factors in patients with COPD in a short term proof of principle study. The key purpose is to determine whether simvastatin improves the pressure and stiffness of the main blood vessels namely the arterial stiffness measure of aortic pulse wave velocity (PWV). In parallel, we will describe changes in airways and / or blood inflammation and change in breathing ability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactose tablet | Placebo comparator | Drug: Lactose tablet |
| Simvastatin 20mg | Active comparator | Drug: Simvastatin |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 45-80 years;
- Confirmed COPD: FEV1 30-80% predicted, FEV1/FVC<0.7, salbutamol reversibility <12%, supportive smoking history
- If female of childbearing potential, have a negative serum pregnancy test at screening and use a medically acceptable form of contraception starting at screening and continuing throughout the study (defined as an oral contraceptive, or barrier method combined with a spermicide)
- Able to attend for regular clinic appointments
- In opinion of investigator, the patient will be able to comply with the requirements of the protocol
Key exclusion criteria (10 listed)
- Known hypersensitivity to or side effects relating to previous statin treatment, or current therapy which includes a statin, ezetimibe or fibrate
- Clinically significant liver function abnormality; alcohol excess
- Hypercholesterolaemia > or equal to 6.5mmol/L
- Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
- Any condition judged by investigator that would cause the study to be detrimental to patient.
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 |
|---|---|---|
| SimvastatinSimvastatin 20mg once daily (in the evening) for 6 weeks | Drug | Simvastatin 20mg |
| Lactose tabletOne tablet taken each evening for 6 weeks | Drug | Lactose tablet |
Primary outcome
Change in arterial stiffness as measured by aortic pulse wave velocity (PWV) over study period
Time frame: Week 0 (start) and week 6 (end)
Aortic Pulse wave velocity (Sphygmocor, Atcor)
14 secondary outcomes
Change in Circulating Inflammatory Mediators over study period
Time frame: Week 0 (Start) and week 6 (End)
Change in distance (metres)walked on 6 minute walking test
Time frame: week 0 (start) and week 6 (end)
Change in blood total cholesterol, triglycerides, HDL and LDL over study period
Time frame: week 0 (Start) and week 6 (End)
Change in airway inflammatory markers (differential cell count, exhaled nitric oxide and airway cytokines) over study period
Time frame: week 0 and week 6
Change in lung function: Spirometry - forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
Time frame: week 0 (Start) and week 6 (End)
Change on blood pressure over study period
Time frame: Week 0 (start) and Week 6 (end)
Change in Liver function tests
Time frame: Week 0 (start) and Week 6 (End)
Change in creatine phosphokinase (CPK) over study period
Time frame: Week 0 (start) and Week 6(End)
Change in Handgrip strength over study period
Time frame: Week 0 (start) and Week 6 (end)
Change in blood desmosine over study period
Time frame: Week 0 (Start) and Week 6 (end)
Change in circulating matrix metalloproteinase over study period
Time frame: Week 0 (start) and Week 6 (end)
Baseline arterial stiffness (aortic pulse wave velocity)
Time frame: Week 0
Baseline airway (differential cell count, exhaled nitric oxide and cytokines)and circulating inflammatory status (cytokines)
Time frame: Week 0
Baseline matrix metalloproteinase in airway and blood
Time frame: Week 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
- Derived from this study: PubMed 25673981John ME, Cockcroft JR, McKeever TM, Coward WR, Shale DJ, Johnson SR, Thornton JG, Harrison TW, Knox AJ, Bolton CE. Cardiovascular and inflammatory effects of simvastatin therapy in patients with COPD: a randomized controlled trial. Int J Chron Obstruct Pulmon Dis. 2015 Jan 29;10:211-21. doi: 10.2147/COPD.S76061. eCollection 2015.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin and Lactose tablet in people with Chronic Obstructive Pulmonary Disease, run by University of Nottingham at 1 site 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Change in arterial stiffness as measured by aortic pulse wave velocity (PWV) over study period (time frame: Week 0 (start) and week 6 (end)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01151306, which also lists 1 linked publication.
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 24 Mar 2014.