Atorvastatin to Treat Pulmonary Sarcoidosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Sarcoidosis, Pulmonary

In brief

This study will determine if atorvastatin (Lipitor) can help patients with pulmonary (lung) sarcoidosis and replace or reduce the need for patients to take steroids, such as prednisone. Sarcoidosis is an inflammatory disease that can affect nearly any part of the body. Pulmonary sarcoidosis may resolve on its own or it may progress to irreversible lung damage, disability, and death. Many sarcoidosis patients are treated with prednisone, but the drug is not effective in all patients, and it can cause serious side effects, such as high blood pressure, sugar diabetes, eye cataracts, and bone thinning. Patients with stage II or III pulmonary sarcoidosis between 18 and 70 years of age who require prednisone may be eligible for this study. Candidates are screened with the tests and procedures described below. Participants are randomly assigned to one of two treatment groups: one group takes atorvastatin; the other takes a placebo (a look-alike pill that has no active ingredient to fight sarcoidosis). Both groups take the pills by mouth once a day for 12 months. When treatment begins, participants begin to have their prednisone dosage tapered (reduced). The tapering is done over 8 weeks until the dose is reduced by 90 percent. Patients are evaluated periodically to determine if the two groups differ in how long they can remain on the reduced dose of prednisone without having their symptoms recur, requiring an increase in the prednisone dose. A full battery of tests is done at the initial screening visit and at the 26- and 52-week follow-up visits, requiring hospitalization for 3-5 days. Additional interim outpatient assessments are done at 6, 12, 18 and 36 weeks. The full battery of tests at the initial screening and the 26- and 52-week visits includes the following: * Medical history, physical examination, blood and urine tests, assessment of disease severity and activity. * Questionnaires. * Chest x-ray (CXR) and computed tomography (CT) scan. * Abdominal ultrasound. * Six-minute walk test (6MWT) * Exercise testing and blood gases * Pulmonary function tests (PFT) * Maximum incremental ventilatory performance test (MIVP) * Exhaled nitric oxide and carbon monoxide (Exhaled NO and CO) * Bronchoscopy and lavage Interim testing at 6, 12, 18 and 36 weeks includes PFT, MIVP, Exhaled NO and CO, CXR, questionnaire, blood tests, and 6MWT. Six months after completing the study, participants fill out a questionnaire.

Key facts

Study ID

NCT00279708

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

55

Starts

2006-01-01

Expected to finish

2015-12-01

Last updated by the study team

2017-05-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Moderate to severe pulmonary fibrosis (stage IV sarcoidosis greater than 50% fibrosis)
• Lung Disease such as asthma, COPD, ILD (other than sarcoid-related)
• History of significant beryllium or asbestos exposure
• Pregnancy; or Active lactation/ child-bearing age female without appropriate birth control methods
• HIV disease
• Hepatitis C and Active Hepatitis B
• Other intervention protocols
• Immunosuppressive therapy (systemic or inhaled) other than corticosteroids or methotrexate
• Significant cardiac disease (NYSHA class greater than III), or serious coronary disease (unstable angina)
• Use of statins within 12 weeks of enrollment
• Allergies or intolerance to statins
• Liver disease (transaminases greater than 1.5X upper limits of normal) or cirrhosis
• Bleeding diathesis that is not correctable
• Inability to perform CPET (cycle ergometer) or PFT maneuvers
• Inability to understand the risks of the trial and the inability to complete the questionnaire
• Malignancy-- requiring chemotherapy or radiation therapy; except certain types of skin cancer that have been excised and have not spread.
• Myopathy, diagnosed via muscle biopsy (other than sarcoid-related myopathy); CPK grater than 1.5 upper limits of normal
• Surgical Risk Category [American Society of Anesthesiologists (ASA) class IV
• Ingestion of grapefruit juice or certain herbal preparations (see below), or medications that are potent inhibitors or inducers of the CYP3A4 system (see section 12.4 under precautions)
• Alcohol abuse (greater than 4 drinks/day)
• Bleeding into the brain or parts of the eyes (retina) (within the past year prior to enrollment)
• Uncontrolled Hypertension (SBP greater than 185 or DBP greater than 100 on two or more visits or assessments)
• Uncontrolled Diabetes Mellitus (Serum glucose level on two or more tests per day greater than 250 mg/dl or erratic blood sugar levels, noted on at least 2 or more assessments; and/or HgbA1C greater than 2x the upper limits of normal).
• Neurosarcoidosis
• Sarcoid Uveitis (Posterior Uveitis) or any Uveitis that cannot be managed with topical steroids alone, as determined by an ophthalmologist

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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