Double-blind Placebo-controlled Pilot Study of Sirolimus in Idiopathic Pulmonary Fibrosis (IPF)

• Register: ClinicalTrials.gov
• Last refreshed on: 29 March 2021
• Main ID: NCT01462006
• Date of registration: 26/10/2011
• Prospective Registration: No
• Primary sponsor: University of Virginia
• Public title: Double-blind Placebo-controlled Pilot Study of Sirolimus in Idiopathic Pulmonary Fibrosis (IPF)
• Scientific title: Double-blind Placebo-controlled Pilot Study of Sirolimus in IPF
• Date of first enrolment: October 2011
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01462006
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Borna Mehrad, MD
• Affiliation: University of Florida

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male and female patients 21-85 years of age

2. Individuals diagnosed with IPF, based on:

- clinical symptoms consistent with idiopathic pulmonary fibrosis (IPF) of > 3
months duration, plus

- histologically diagnosed UIP or diagnostic chest high resolution CT features of
UIP, plus

- negative workup for known causes of UIP

3. Ability to understand a written informed consent form and comply with the requirements
of the study.

Exclusion Criteria:

1. Clinical features or known diagnosis of an active infection, including untreated
latent tuberculosis

2. Clinical features or known diagnosis of malignancy

3. Known diagnosis of an interstitial lung disease other than IPF including but not
limited to sarcoidosis, hypersensitivity pneumonitis, non-specific interstitial
pneumonia (NSIP).

4. History of clinically significant environmental exposures known to cause interstitial
lung disease (including but not limited to drugs, asbestos, silica, beryllium,
radiation, domestic birds, etc).

5. Diagnosis of any connective tissue disease (including but not limited to scleroderma,
SLE, rheumatoid arthritis) or vasculitides according to the American College of
Rheumatology criteria.

6. Systolic blood pressure < 100 or >145 mm Hg or diastolic blood pressure < 50 or >90
mmHg

7. Evidence of active infection within 1 week prior to enrollment.

8. Recently started (<8 weeks prior to baseline visit) or planned cardiopulmonary
rehabilitation program before conclusion of the study

9. History of unstable or deteriorating cardiac disease, including but not limited to:
myocardial infarction, coronary artery bypass surgery or angioplasty within the past 6
months, congestive heart failure requiring hospitalization within the past 6 months,
or uncontrolled arrhythmia

10. History of unstable or deteriorating neurologic disease, including but not limited to:
TIAs or stroke

11. Pregnant or lactating females. Females of child bearing potential are required to have
a negative serum or urine pregnancy test prior to treatment and agree to practice
abstinence or prevent pregnancy by at least a barrier method of birth control.

12. Liver panel above specific limits at screening: Total bilirubin >1.5-fold upper limit
of normal, AST, ALT or alkaline phosphatase > 3-fold upper limit of normal at
screening.

13. Hematology outside of specified limits, WBC <2,500/ mm3, hematocrit <30, platelets
<100,000/mm3 at screening.

14. Investigational therapy for any indication within 28 days prior to treatment.

15. Current treatment with drugs that are strong inhibitors of CYP3A4 or P-gp, namely
bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole,
HIV-protease inhibitors (e.g., ritonavir, indinavir), metoclopramide, nicardipine,
troleandomycin, verapamil

16. Inability or unwillingness to comply with the requirements for the trial.



Age minimum: 21 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diffuse Parenchymal Lung Disease

Interstitial Lung Disease

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: sirolimus

Other: Placebo

Primary Outcome(s)

fibrocytes [Time Frame: up to 22 weeks]

number of subjects with drug side-effects [Time Frame: up to 22 weeks]

Secondary ID(s)

R01HL098329

15282

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)