COPDPhase 3NCT01944176
The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokine in COPD Patients
A Phase 3 study of COPD, run by Mahidol University at 1 site in Thailand.
Trial summary
Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as atherosclerosis and multiple sclerosis in mouse model. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- COPD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2013to Aug 2014
- Phase
- Phase 3
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable COPD without an exacerbation within 3 months prior to study entry
- mild, moderate and severe COPD with or without treatments, regardless of COPD medications
Who cannot join
- Concomitant other chronic lung diseases including with TB and malignancy
- HIV
- Being on immunosuppressive drugs and systemic corticosteroids
- Dyslipidemic patients with recent cardiovascular or cerebrovascular disease within 6 month prior to study entry
- Cognitive impairment
- Currently on macrolides, azole anti-fungal agents, amiodarone and amlodipine
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, BKK, 10700
About this study
Official title: The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokines in COPD Patients
Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD patients.
- Conditions
- COPD
- Being tested
- simvastatin, placebo
- Keywords
- COPD, Statins, Cytokines
- 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.
simvastatin, placeboDrug
Also called Bestatin, B1-6-12
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | simvastatin 20 mg/d is randomized to treat COPD patients for 4 weeks Receives: Drug: simvastatin, placebo |
| B1-6-12 | Placebo comparator | B1-6-12 one tablet a day is randomized to give to COPD patients for 4 weeks Receives: Drug: simvastatin, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum cytokines
Measured: Up to 4 weeks
Secondary outcomes (2)
FEV1
Measured: Up to 4 weeks
Sputum neutrophils
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
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 COPDStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipong Maneechotesuwan, Mahidol University
- Investigators
- Kittipong Maneechotesuwan, MD., PhD., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944176
- Sponsor's protocol ID
- Si323/2013
- Status last verified
- Mar 2016
- First submitted
- 10 Sep 2013
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Maneechotesuwan K, Wongkajornsilp A, Adcock IM, Barnes PJ. Simvastatin Suppresses Airway IL-17 and Upregulates IL-10 in Patients With Stable COPD. Chest. 2015 Nov;148(5):1164-76. doi: 10.1378/chest.14-3138.
PubMed 26043025
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokines in COPD Patients
- ClinicalTrials.gov ID
- NCT01944176
- Acronym / sponsor ID
- Si323/2013
- Conditions
- COPD
- Keywords
- COPD, Statins, Cytokines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Sep 2013 (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.
Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: simvastatin, placebosimvastatin 20 mg/d is randomized to treat COPD patients for 4 weeks |
| B1-6-12 | Placebo comparator | Drug: simvastatin, placeboB1-6-12 one tablet a day is randomized to give to COPD patients for 4 weeks |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable COPD without an exacerbation within 3 months prior to study entry
- mild, moderate and severe COPD with or without treatments, regardless of COPD medications
Key exclusion criteria (6 listed)
- Concomitant other chronic lung diseases including with TB and malignancy
- HIV
- Being on immunosuppressive drugs and systemic corticosteroids
- Dyslipidemic patients with recent cardiovascular or cerebrovascular disease within 6 month prior to study entry
- Cognitive impairment
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 |
|---|---|---|
| simvastatin, placeboAlso: Bestatin, B1-6-12 | Drug | B1-6-12, Simvastatin |
Primary outcome
Sputum cytokines
Time frame: Up to 4 weeks
2 secondary outcomes
FEV1
Time frame: Up to 4 weeks
Sputum neutrophils
Time frame: Up to 4 weeks
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 16 Mar 2016.
- Derived from this study: PubMed 26043025Maneechotesuwan K, Wongkajornsilp A, Adcock IM, Barnes PJ. Simvastatin Suppresses Airway IL-17 and Upregulates IL-10 in Patients With Stable COPD. Chest. 2015 Nov;148(5):1164-76. doi: 10.1378/chest.14-3138.
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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.
Kittipong Maneechotesuwan, MD., PhD. principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of COPD, run by Mahidol University at 1 site in Thailand.
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 2 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: finished, as of the sponsor's last update on 16 Mar 2016. 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 Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Sputum cytokines (time frame: Up to 4 weeks). 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 NCT01944176, 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 16 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.