Status and phase
Conditions
Treatments
About
Full description
INSPIRE, the largest and most comprehensive clinical trial ever conducted in IPF, has now completed enrolling patients with mild to moderate IPF. Eligible patients will receive either Interferon gamma-1b or placebo for a minimum of 2 years.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Clinical symptoms consistent with IPF of >= 3 months duration
Diagnosis of IPF within 48 months before randomization
Age 40 through 79, inclusive
High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients with surgical lung biopsy showing definite or probable usual interstitial pneumonia (UIP), the HRCT criterion of probable IPF is sufficient.
For patients aged < 50 years: open or video-assisted thoracoscopic (VATS) lung biopsy showing definite or probable UIP within 48 months before randomization. In addition, there are no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage (BAL) if performed.
For patients aged < 50 years: At least one of the following diagnostic findings, as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis, within 48 months before randomization:
FVC >= 55% of predicted value (post administration of bronchodilator)
Hemoglobin (Hb)-corrected carbon monoxide diffusing capacity/carbon monoxide transfer capacity (DLCO/TLCO) >= 35% of predicted value
At least one of either FVC or Hb-corrected DLCO/TLCO <= 90% of predicted value
IPF disease progression evidenced by one or more of the following within the past year and the absence of evidence of improvement in the past year:
Distance walked >= 150 meters (492 feet) with O2 saturation >= 83% on <= 6 L/min of O2 during the 6 Minute Walk Test (6MWT) oxygen titration procedure
Exclusion criteria
Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the Principal Investigator (PI)
Forced expiratory volume in the first second (FEV1)/FVC ratio < 0.6 (after administration of bronchodilator)
Residual volume (RV) > 140% of predicted (before administration of bronchodilator)
History of clinically significant environmental exposure known to cause pulmonary fibrosis (including but not limited to drugs, asbestos, beryllium, radiation, domestic birds)
Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, and cancer
Diagnosis of any connective tissue disease, including but not limited to scleroderma, systemic lupus erythematosus, and rheumatoid arthritis
Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis
On a lung transplantation waiting list at time of randomization
Medical Exclusions:
Any history of malignancy likely to result in death, significant disability, or likely to require significant medical or surgical intervention within the next 3 years. This does not include minor surgical procedures for localized carcinoma (e.g., basal cell carcinoma)
Any condition other than IPF which, in the opinion of the PI, is likely to result in the death of the patient within the next 3 years
History of unstable or deteriorating cardiac, vascular, or neurologic disease within the previous 6 months, including but not limited to the following:
Any condition, which, in the opinion of the investigator, might be significantly exacerbated by the known side effects, (e.g., flu-like syndrome) associated with the administration of IFN g 1b
History of any of the following medical conditions:
Pregnancy or lactation. Females of childbearing potential are required to have a negative serum pregnancy test before treatment and must agree to practice abstinence or prevent pregnancy by at least a barrier method of birth control for the duration of the study
Inability to tolerate nonsteroidal anti-inflammatory drugs (NSAIDS) or acetaminophen (paracetamol)
History of ethanol abuse in the past 2 years
Known hypersensitivity to IFN-g or closely related interferons or to any component of the study treatment
Presence of human immunodeficiency virus (HIV) or chronic viral hepatitis
Laboratory Exclusions:
Any of the following liver function test criteria above specified limits:
Total bilirubin > 1.5 x upper limit of normal (ULN); aspartate or alanine aminotransferases (AST/SGOT or ALT/SGPT) > 2 x ULN; alkaline phosphatase > 2 x ULN; or albumin < 3.0 mg/dL
Any of the following hematology test criteria outside of specified limits: WBC < 2,500/mm3, hematocrit < 30% or > 59%, platelets < 100,000 /mm3
Creatinine > 1.5 x ULN
Concomitant Therapy Exclusions:
Prednisone therapy (prednisone or equivalent, with dose adjusted for potency) in excess of 0.125 mg/kg ideal body weight (IBW) per day or in excess of 0.25 mg/kg IBW every other day. Patients will also be excluded if they were not on a stable dose of corticosteroid therapy for at least 28 days prior to screening.
Prior treatment with IFN g 1b
Investigational therapy (i.e., agents that are not approved by local regulatory agencies) for any indication within 28 days prior to screening
The following therapies are excluded within 28 days prior to screening:
Primary purpose
Allocation
Interventional model
Masking
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal