Severe AsthmaPhase 2NCT02433535
Trial of Simvastatin for the Treatment of Severe Asthma
A Phase 2 study testing Simvastatin in people with Severe Asthma, run by University of California, Davis at 1 site in United States.
Trial summary
This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation, improve lung function and symptoms, and reduce acute exacerbations in patients with severe asthma who are already on controller inhaler… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 22 Aug 2017
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- statin-naïve adults >18 years old with the ATS definition of severe asthma,
- on ICS and LABA,
- confirmation of allergic asthma (serum IgE >100 kU/L, positive radioallergosorbent test (RAST) panel, and/or peripheral blood absolute eosinophil count of ≥700/mm3),
- clinically stable for 4 weeks.
Who cannot join
- baseline FEV1 <30% predicted,
- current smokers or ex-smokers with >5 pack-years of smoking history,
- pregnant women, nursing/lactating mothers, or women of childbearing potential who are actively attempting to become pregnant,
- nasal or sinus surgery or trauma within 3 months of study participation,
- ischemic heart disease,
- liver disease, and
- the concurrent use of the following medications (amiodarone, verapamil, diltiazem, gemfibrozil, cyclosporine, antifungal azoles (itraconazole, ketoconazole, or voriconazole), and danazol.
Trial locations and contacts
1 site in 1 country.
United States1 site
CTSC Clinical Research Center
Sacramento, California, 95817
About this study
Official title: Randomized Trial of Simvastatin for the Treatment of Severe Asthma
This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation, improve lung function and symptoms, and reduce acute exacerbations in patients with severe asthma who are already on controller inhaler therapy.
This proposed investigator-initiated, single-center, early Phase II, cross-over, randomized clinical trial, titled "Randomized Trial of Simvastatin for the Treatment of Severe Asthma", will be conducted at the University of California, Davis Medical Center (UCDMC) in Sacramento, CA. This trial will evaluate Simvastatin for treatment of asthma in subjects with severe asthma (as defined by the American Thoracic Society (ATS)), who are already taking inhaler controller therapy. The investigators plan to enroll 24 patients with severe allergic asthma.
The investigators hypothesize that treatment with Simvastatin 40 mg (administered once daily) will not only improve indicators of airway and systemic allergic/Th2 inflammation, but will also reduce acute exacerbations and improve lung function. All patients will be on standard controller therapy including appropriate doses of inhaled corticosteroids and long-acting bronchodilators.
Read the detailed description
See above.
- Conditions
- Severe Asthma
- Being tested
- Simvastatin, Placebo
- Keywords
- severe asthma, simvastatin, allergic airway inflammation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor
Simvastatin is used to lower cholesterol, however, it also possess anti-inflammatory and immunomodulatory properties that may also alleviate allergic airway inflammation in asthma.
PlaceboOther
A placebo pill will be given to the placebo group. There will be no detectible differences between study drug pill and placebo pill.
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | Simvastatin 40 mg daily will be given for 12 weeks. Receives: Drug: Simvastatin |
| Placebo | Placebo comparator | A placebo capsule will be given daily for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Th2 gene expression in nasal epithelial cells.
IL13, eotaxin-1,-2,-3, STAT6) by RT-PCR.
Measured: Before and after 12 weeks of drug or placebo intervention.
Exhaled nitric oxide (ENO)
ENO will be measured using our NIOX-Mino portable NO analyzer.
Measured: Before and after 12 weeks of drug or placebo intervention.
Secondary outcomes (3)
Acute Exacerbations
Assessed as a rate per month.
Measured: Before and after 12 weeks of drug or placebo intervention.
Lung function
FEV1, FVC, and FEV/FVC ratio.
Measured: Before and after 12 weeks of drug or placebo intervention.
Asthma symptom control score
Asthma Control Test score (5 question survey).
Measured: Before and after 12 weeks of drug or placebo intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startDec 2013
- Primary completion22 Aug 2017
- Study completion22 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433535
- Sponsor's protocol ID
- 522110
- Other IDs
- 522110-3
- Status last verified
- Sep 2017
- First submitted
- 29 Apr 2015
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Simvastatin for the Treatment of Severe Asthma
- ClinicalTrials.gov ID
- NCT02433535
- Acronym / sponsor ID
- 522110
- Conditions
- Severe Asthma
- Keywords
- severe asthma, simvastatin, allergic airway inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- 22 Aug 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 5 May 2015 (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.
This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation, improve lung function and symptoms, and reduce acute exacerbations in patients with severe asthma who are already on controller inhaler therapy.
This proposed investigator-initiated, single-center, early Phase II, cross-over, randomized clinical trial, titled "Randomized Trial of Simvastatin for the Treatment of Severe Asthma", will be conducted at the University of California, Davis Medical Center (UCDMC) in Sacramento, CA. This trial will evaluate Simvastatin for treatment of asthma in subjects with severe asthma (as defined by the American Thoracic Society (ATS)), who are already taking inhaler controller therapy. The investigators plan to enroll 24 patients with severe allergic asthma.
The investigators hypothesize that treatment with Simvastatin 40 mg (administered once daily) will not only improve indicators of airway and systemic allergic/Th2 inflammation, but will also reduce acute exacerbations and improve lung function. All patients will be on standard controller therapy including appropriate doses of inhaled corticosteroids and long-acting bronchodilators.
Detailed description
See above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: SimvastatinSimvastatin 40 mg daily will be given for 12 weeks. |
| Placebo | Placebo comparator | Other: PlaceboA placebo capsule will be given daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- statin-naïve adults >18 years old with the ATS definition of severe asthma,
- on ICS and LABA,
- confirmation of allergic asthma (serum IgE >100 kU/L, positive radioallergosorbent test (RAST) panel, and/or peripheral blood absolute eosinophil count of ≥700/mm3),
- clinically stable for 4 weeks.
Key exclusion criteria (7 listed)
- baseline FEV1 <30% predicted,
- current smokers or ex-smokers with >5 pack-years of smoking history,
- pregnant women, nursing/lactating mothers, or women of childbearing potential who are actively attempting to become pregnant,
- nasal or sinus surgery or trauma within 3 months of study participation,
- ischemic heart disease,
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 |
|---|---|---|
| SimvastatinAlso: ZocorSimvastatin is used to lower cholesterol, however, it also possess anti-inflammatory and immunomodulatory properties that may also alleviate allergic airway inflammation in asthma. | Drug | Simvastatin |
| PlaceboA placebo pill will be given to the placebo group. There will be no detectible differences between study drug pill and placebo pill. | Other | Placebo |
Primary outcome
Th2 gene expression in nasal epithelial cells.
Time frame: Before and after 12 weeks of drug or placebo intervention.
IL13, eotaxin-1,-2,-3, STAT6) by RT-PCR.
Exhaled nitric oxide (ENO)
Time frame: Before and after 12 weeks of drug or placebo intervention.
ENO will be measured using our NIOX-Mino portable NO analyzer.
3 secondary outcomes
Acute Exacerbations
Time frame: Before and after 12 weeks of drug or placebo intervention.
Lung function
Time frame: Before and after 12 weeks of drug or placebo intervention.
Asthma symptom control score
Time frame: Before and after 12 weeks of drug or placebo intervention.
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 26 Sep 2017.
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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.
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 2 study testing Simvastatin in people with Severe Asthma, run by University of California, Davis at 1 site in United States.
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 4 inclusion and 7 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 26 Sep 2017. 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 States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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.
What does the primary outcome measure?
Th2 gene expression in nasal epithelial cells. (time frame: Before and after 12 weeks of drug or placebo intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 26 Sep 2017.