Get Involved

Instage-IPF IMP study

What is the purpose of this trial?

  • To investigate if combining two drugs, called nintedanib and sildenafil, is effective in the treatment of your condition. For assessing this, you will be asked to respond to questionnaires about how you feel, about your condition and about your symptoms during the course of the trial. You will also be asked to do breathing tests.
  • To investigate the safety of nintedanib and sildenafil when given together, and how you tolerate (accept) this combination treatment.
  • To collect your blood and assess pharmacokinetics (how the trial drugs are absorbed, distributed and broken down in the body), biomarkers (how other proteins in your body are influenced by the trial drugs), and pharmacogenetics (if response to the trial drugs is related to a certain part of your genes).

What will happen to me if I take part?

You will be assigned by random choice to receive either the trial drug combination of nintedanib and sildenafil or to receive nintedanib and an inactive substance (placebo). A placebo is a substance that looks like the trial drug, but contains no active drug. This process is called randomisation. You will have an equal chance of being placed in any of the following groups:

 A: combination of nintedanib and sildenafil

B: combination of nintedanib and placebo

This trial will be double-blinded. No one (including you and the trial team) will know which combination you are receiving. This way the results of the trial will not be favoured one way or another. If it becomes necessary for your care, your trial doctor will be able to find out which medications you are taking.

Time to be spent in the trial

Your participation in the trial will last approximately 7-8 months and requires approximately 8 visits to the trial clinic. Your research nurse will take you through what will happen at each stage and visit.

If you would like to know more about this please contact:

Judith Moore, Clinical Trials Officer (0191) 404 1000 Ex 2263

Customer Services, (0191) 404 1072

Clinical Trials in Respiratory Disorders

Select a trial from the list below to find out more about what it’s all about and how you can get involved in helping others.

EMBARC – The European Bronchiectasis Registry

This study is seeking to establish a register of patients diagnosed with bronchiectasis around Europe.

EME – TIPAC – Idiopathic Pulmonary Fibrosis Study

Treating pulmonary fibrosis with co-trimoxazole

LuCID Lung Cancer Indicator Detection

The goal of this study is to carefully look at the compounds someone exhales to determine if analysis of exhaled breath can detect lung cancer.

NIVO – 1 year longitudinal follow up after assisted ventilation

This study aims to track the progress of patients that have required assisted ventilation for one year after discharge from hospital.

Instage-IPF IMP study

This study is for patients that have been diagnosed with Idiopathic pulmonary fibrosis.

MARS2

The aim of the MARS2 study is to determine if it is feasible to enrol patients with mesothelioma into a study randomising them to chemotherapy only or chemotherapy and lung-sparing surgery.


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