Severe Persistent AsthmaPhase 1/2NCT00689806
Evaluation of Lovastatin in Severe Persistent Asthma
A Phase 1/2 study testing Lovastatin in people with Severe Persistent Asthma, run by University of Chicago.
Trial summary
This study has two purposes: 1. to determine whether lovastatin, a commonly used medication to lower cholesterol in the blood, can produce beneficial changes in airway inflammation and in the airway smooth muscle 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Persistent Asthma
- What is being tested?
- Lovastatin
- 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
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years to <65 years
- Severe persistent asthma (per 2002 National Asthma Education and Prevention Program guidelines)
- Treatment with daily fluticasone (500 ug BID) and salmeterol (50 ug BID) during the past 4 or more weeks
- Pre-bronchodilator FEV1 <80% predicted
- Post-bronchodilator improvement in FEV1 of at least 12% and 200 mL or a PC20 to methacholine of <8 mg/mL
- Evidence of inadequate asthma control in the past 2 weeks: use of rescue inhaler > 4 days and >8 occasions in the past 2 weeks, daytime asthma symptoms > 4 days in the past 2 weeks, or 1 or more nocturnal awakening in the past 2 weeks
- No evidence of alternate diagnosis (e.g., sarcoidosis, eosinophilic pneumonia) on bronchoscopy performed as part of routine care in the Refractory Obstructive Lung Disorders clinic.
- Completed research bronchoscopy while on current dose of daily fluticasone and salmeterol within 4 weeks of meeting other inclusion criteria. Note: many patients in the ROLD clinic require a bronchoscopy to confirm the diagnosis of asthma and exclude other diagnosis (e.g., sarcoidosis). These patients are asked to participate in a research protocol (separate from this proposal) that allows investigators to collect additional samples (endobronchial biopsies, bronchoalveolar lavage fluid, endobronchial brushings) at the end of the clinical portion of the bronchoscopy {IRB protocol # 15361A entitled, "Airway inflammation in refractory obstructive lung disease (ROLD): understanding markers of inflammation and remodeling"}. This protocol was recently submitted to the IRB in March 2007.
Who cannot join
- Pregnancy or lactation
- Severe metabolic disease
- Other respiratory or inflammatory disorders (sarcoidosis, emphysema)
- Hypokalemia, dehydration
- Uncontrolled seizure disorder ( 2 or more seizures in last year)
- Major surgery, trauma
Show all 16Show fewer
- Pre-existing liver disease (AST or ALT >10% above the upper limit of normal)
- Elevated CK (>50% above the upper limit of normal)
- History of alcohol abuse
- Current smokers or ex-smokers with > 10 pack-years of smoking
- Partial ileal bypass surgery
- Concurrent treatment with drugs known to be have potential interactions or associated with rhabdomyolysis (Cimetadine, danazole, delavaridine, diltiazem, fenofiibrate, nefazodone, niacin, protease inhibitors, quinipristoline/dalfopristin, ranolazine, rifampin, telbivudine, telithromycin)
- HIV patients taking protease inhibitors
- History of allergy or intolerance to statin
- Use of 1 or more doses of any cholesterol lowering medication in the previous 12 weeks
- Clinical indication for treatment with statins
About this study
This study has two purposes:
- to determine whether lovastatin, a commonly used medication to lower cholesterol in the blood, can produce beneficial changes in airway inflammation and in the airway smooth muscle
- to examine whether lovastatin will have favorable changes in asthma symptoms of patients with moderate or severe asthma.
- Conditions
- Severe Persistent Asthma
- Being tested
- Lovastatin, Placebo
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LovastatinDrug
Lovastatin 20 mg extended release (or placebo) by mouth once daily for weeks 1-4. Liver function test will be checked at week 4 follow up visit. If LFTs are not > 3 times the upper limit of normal, then the subject will have the dose of extended release lovastatin increased to 60 mg once a day for weeks 4-12
PlaceboDrug
Placebo by mouth once daily for weeks 1-4.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Lovastin | Active comparator | Not described Receives: Drug: Lovastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in airway smooth muscle biology and inflammatory measures
Measured: 12 Weeks
Secondary outcomes (1)
Changes in asthma control, lung function and quality of life from the baseline visit to the end of the follow-up period
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
Why it stopped: Study never opened
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Persistent AsthmaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blanca Camoretti-Mercado, Ph.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689806
- Sponsor's protocol ID
- 15427A
- Other IDs
- UL1RR024999
- Status last verified
- Jun 2013
- First submitted
- 23 May 2008
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lovastatin in Severe Persistent Asthma
- ClinicalTrials.gov ID
- NCT00689806
- Acronym / sponsor ID
- 15427A
- Conditions
- Severe Persistent Asthma
- Keywords
- Asthma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never opened
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- First posted
- 4 Jun 2008 (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 study has two purposes:
- to determine whether lovastatin, a commonly used medication to lower cholesterol in the blood, can produce beneficial changes in airway inflammation and in the airway smooth muscle
- to examine whether lovastatin will have favorable changes in asthma symptoms of patients with moderate or severe asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Lovastin | Active comparator | Drug: Lovastatin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years to <65 years
- Severe persistent asthma (per 2002 National Asthma Education and Prevention Program guidelines)
- Treatment with daily fluticasone (500 ug BID) and salmeterol (50 ug BID) during the past 4 or more weeks
- Pre-bronchodilator FEV1 <80% predicted
- Post-bronchodilator improvement in FEV1 of at least 12% and 200 mL or a PC20 to methacholine of <8 mg/mL
Key exclusion criteria (16 listed)
- Pregnancy or lactation
- Severe metabolic disease
- Other respiratory or inflammatory disorders (sarcoidosis, emphysema)
- Hypokalemia, dehydration
- Uncontrolled seizure disorder ( 2 or more seizures in last year)
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 |
|---|---|---|
| LovastatinLovastatin 20 mg extended release (or placebo) by mouth once daily for weeks 1-4. Liver function test will be checked at week 4 follow up visit. If LFTs are not > 3 times the upper limit of normal, then the subject will have the dose of extended release lovastatin increased to 60 mg once a day for weeks 4-12 | Drug | Lovastin |
| PlaceboPlacebo by mouth once daily for weeks 1-4. | Drug | Placebo |
Primary outcome
Changes in airway smooth muscle biology and inflammatory measures
Time frame: 12 Weeks
1 secondary outcome
Changes in asthma control, lung function and quality of life from the baseline visit to the end of the follow-up period
Time frame: 13 weeks
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 21 Jun 2013.
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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.
Blanca Camoretti-Mercado, Ph.D. principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lovastatin in people with Severe Persistent Asthma, run by University of Chicago.
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 8 inclusion and 16 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 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Changes in airway smooth muscle biology and inflammatory measures (time frame: 12 Weeks). 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 21 Jun 2013.