1199.36 Nintedanib + Sildenafil in advanced IPF

• Research type

  Research Study

• Full title

  A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministered with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment

• IRAS ID

  202344

• Contact name

  Ken Scrine

• Contact email

  ken.scrine@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2015-002619-14

• Duration of Study in the UK

  1 years, 10 months, 11 days

• Research summary

  This study aims to assess the efficacy and safety of nintedanib when co-administered with sildenafil, compared to treatment with nintedanib alone, in patients with Idiopathic Pulmonary Fibrosis (IPF) and advanced lung function impairment. It is thought that combining these two drugs might provide additional benefits to patients with IPF.

  The main criteria a patient must satisfy to be eligible for the trial are:
  - Provide written informed consent
  - Male or female patients aged ≥ 40 years
  - IPF diagnosed within the last 6 years and confirmed by a chest scan performed within the last 18 months and surgical lung biopsy (if available)
  - Carbon Monoxide Diffusion Capacity (DLCO - a measurement of lung function) must be ≤35% of predicted normal

  A total of approximately 250 patients will be treated with either nintedanib co-administered with sildenafil (125 patients) or nintedanib co-administered with placebo matching sildenafil (125 patients). The treatment will last 24 weeks. Treatment will be preceded by a screening period of up to 4 weeks during which it will be confirmed if the patient is eligible to participate in the trial. After the treatment is finished patients will be followed up for a further 4 weeks. So each patient’s participation in the trial is estimated to last approximately 32 weeks in total.

  The study will be conducted in hospitals. Patients will have an echocardiogram during the screening period. Additional testing will include routine safety procedures such as safety laboratory testing, physical examinations, spirometry, ECGs and vital signs.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  16/EE/0235

• Date of REC Opinion

  1 Aug 2016

• REC opinion

  Further Information Favourable Opinion