Principal Investigator: Mary  Scholand
Keywords: pulmonary fibrosis , nintedanib , ofev Department: Pulmonary
IRB Number: 00117658
Specialty: Pulmonary
Sub Specialties: Pulmonary Fibrosis
Recruitment Status: Active, not recruiting

Contact Information

Scott Sweeten
joseph.martinez@hsc.utah.edu
8015815811

Brief Summary

The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)who have completed (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).
 

The primary endpoint is the incidence of overall adverse events over the course of this extension trial. 

No secondary efficacy endpoints are defined.

Further endpoints are as follows:

  • Absolute and relative change from baseline in FVC (mL) and in % predicted FVC over time in this extension trial.
  • Proportion of patients with progression (defined as a≥ 10% absolute decline in FVC percent predicted) or death in this extension trial (on an annual basis over time)
  • Proportion of patients with an absolute decline since baseline in FVC percent predicted >10%  in this extension trial(on an annual basis over time)
  • Proportion of patients  with an absolute decline since baseline in FVC percent predicted >5%  in this extension trial(on an annual basis over time)  Proportion of patients with at least one acute ILD exacerbation or death in this extension trial(on an annual basis over time)
  • Time to death in this extension trial

Inclusion Criteria

1. Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.


2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

3. Women of childbearing potential(WOCBP)1 must continue to use highly effective methods of birth control per ICH M3(R2)that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method,for 28 days prior to and 3 months after nintedanib administration.A list of contraception methods meeting these criteria is provided in the patient information.

Exclusion Criteria

1. Any disease that may put the patient at risk when participating in this trial.  Reconsider carefully all exclusion criteria of the INBUILD®trial (see Appendix 10.1).However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator’s benefit-risk assessment remains favourable.


2. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial

3. Patient not compliant in parent trial(INBUILD®), with trial medication or trial visits, according to investigator’s judgement. 


4. Previous enrollment in this trial. 

5. Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.


6. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.