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8110 Gatehouse Road, Falls Church, VA 22042

A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

General Information

Age Group

Adult

Status

Active

Protocol Number

1199.247

Background Information

The purpose of this study is to compare the safety and effect of an oral (by mouth) treatment, nintedanib, to placebo, in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD). This would be demonstrated as a reduction in lung function decline (FVC) over 52 weeks.

National Clinical Trial (NCT) identifier on clinicaltrials.gov: NCT02999178

Offered At

Inova Heart and Vascular Institute, Advanced Lung Disease and Transplant Clinic, 3300 Gallows Road, Falls Church, VA 22042

Principal Investigator

Oksana Shlobin, MD

Eligibility Information

Inclusion

  • Male or female patients aged ≥ 18 years at screening
  • Patients with physician diagnosed Interstitial Lung Disease (ILD) who fulfil at least one of the following criteria for Progressive Fibrosing Interstitial Lung Disease (PF-ILD) within 24 months of screening visit (Visit 1):
    • Clinically significant decline in Forced Vital Capacity (FVC) % pred based on a relative decline of ≥ 10%
    • Marginal decline in FVC % pred based on a relative decline of ≥ 5 to <10% combined with worsening of respiratory symptoms
    • Marginal decline in FVC % pred based on a relative decline of ≥ 5 to <10% combined with increasing extent of fibrotic changes on chest imaging
    • Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
      [Note: Changes attributable to comorbidities e.g. infection, heart failure must be excluded. Unapproved medications used in the clinical practice to treat ILD include but are not limited to corticosteroid, azathioprine, mycophenolate mofetil (MMF), n-acetylcysteine (NAC), rituximab, cyclophosphamide, cyclosporine, tacrolimus].
  • Fibrosing lung disease on HRCT with disease extent of >10%, performed within 12 months of screening
  • For patients with underlying Connective Tissue Disease (CTD): stable CTD as defined by no initiation of new therapy or withdrawal of therapy for CTD within 6 weeks prior to screening
  • Carbon Monoxide Diffusion Capacity (DLCO) corrected for Haemoglobin (Hb) [visit 1] ≥ 30% and <80% predicted at randomization
  • FVC ≥ 45% predicted at randomization

Ineligibility Information

Exclusion

  • Previous treatment with nintedanib or pirfenidone.
  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on ATS/ERS/JRS/ALAT 2011 Guidelines.
  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on American Thoracic Society (ATS)/ European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) 2011 Guidelines.
  • Other investigational therapy received within 1 month or 6 half-lives (whichever was greater) prior to screening visit
  • Use of any of the following medications for the treatment of Interstitial Lung Disease (ILD): azathioprine (AZA), cyclosporine, MMF, tacrolimus, oral corticosteroids (OCS) >20mg/day and the combination of OCS+AZA+NAC within 4 weeks of randomization (Visit 2), cyclophosphamide within 8 weeks of Visit 2, rituximab within 6 months of visit 2
  • Significant Pulmonary Arterial Hypertension (PAH)
  • Cardiovascular disease that includes severe hypertension (≥160/100 mmHg), myocardial infarction, or unstable cardiac angina within 6 months of screening
  • Bleeding risk, including patients that require full dose anti-coagulation or anti-platelet therapy
  • Allergies to soya lecithin or peanuts
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial