Research

Clinical Trials

About this page
This section of the website is used to post information about relevant clinical trials in Canada as we are made aware of them. At the Foundation, we recommend you ask your doctor whether there are any clinical trials going on that you may be able to join. This has two benefits: firstly, you will have the opportunity to try new drugs that, hopefully, will come on the market and which may help you; and secondly, you are contributing to important research and that will make you feel good.
Clinical Trials and Drug Safety in Canada
Why Participate in a Clinical Trial
Dr. Gerard (Gerry) Cox talks briefly about what a clinical trial is, how a clinical trial is run, generally what drugs are being tested for IPF, and why you should participate in a clinical trial. The video is a recording of an interview with Dr. Cox shown to high school students from Hamilton, Ontario on December 2nd, 2013.

Clinical Trials in Canada
If you become aware of a relevant clinical trial for pulmonary fibrosis patients, please contact us at news.cpff@gmail.com and we will add it here.

Efficacy and Safety of Nintedanib When Co-administered With Sildenafil
Efficacy and Safety of Nintedanib When Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment – Phase 3

https://clinicaltrials.gov/ct2/show/study/NCT02802345

Sponsored by Boehringer Ingelheim

Study Locations (as of Jan. 3, 2017):  (Recruiting) Vancouver,BC; Hamilton, ON; Halifax, NS. (Not yet recruiting)  Edmonton, AB; Toronto, ON.

Pirfenidone in Combination With Nintedanib in IPF
Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF) – Phase 4

https://clinicaltrials.gov/ct2/show/study/NCT02598193

Sponsored by Hoffman-La Roche — Pirfenidone and Nintedanib are anti-fibrotic drugs that are administered orally.

Study Locations (as of Nov. 1, 2016):  Calgary, AB; Toronto, ON.

IPF Patients treated with Nintedanib (HOPE-IPF)
High Oxygen Delivery to Preserve Exercise Capacity in Idiopathic Pulmonary Fibrosis Patients Treated With Nintedanib (HOPE-IPF)

https://clinicaltrials.gov/ct2/show/study/NCT02551068

Sponsored by University of British Columbia
Collaborator Boehringer Ingelheim

Study Locations as of May 4, 2016:  (Recruiting) St. Paul’s Hospital, Vancouver, BC   (Not yet recruiting) Vancouver General Hospital, Vancouver, BC; UBC Okanagan, Kelowna, BC; University of Calgary, AB; University of Alberta, Edmonton, AB; McMaster University, Hamilton, ON; Queen’s University, Kingston, ON; McGaill University, Montreal, QC; Laval University, Quebec City, QC

FG-3019 for Patients with IPF
Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis – Phase 2

https://clinicaltrials.gov/ct2/show/study/NCT01890265

Sponsored by FibroGen — intravenous infusion every 3 weeks.

Study Locations as of July 28, 2016:

Quebec City, QC (Recruiting)

Université de Sherbrooke / Hôpital Charles LeMoyne
Quebec City, Canada, J4V2H1
Contact: Nadim Srour, M.D. 450-466-5000 ext 3834 nadim.srour@usherbrooke.ca
Contact: Geneviève Bujold, R.N. 450-466-5000 ext 2164 genevieve.bujold.cssscclm16@ssss.gouv.qc.ca
Principal Investigator: Nadim Srour, M.D

Institut universitaire de Cardiologie et de Pneumologie de Québec
Quebec city, Quebec, Canada, G1V 4G5
Contact: Steeve Provencher, M.D. 418-656-4747 steve.provencher@criucpq.ulaval.ca
Contact: Luce Bouffard 418-656-8711 ext 2499 luce.bouffard@criucpq.ulaval.ca
Principal Investigator: Steeve Provencher, M.D.

Observational Study Esbriet {Pirfenidone)
Observational Study to Evaluate Disease Course and Outcomes in Patients Treated With Esbriet (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF) in Canada – Phase 4

https://clinicaltrials.gov/ct2/show/study/NCT02552849

Study Locations:  Please click on above link for numerous locations.

SAR156597 for Patients with IPF
Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (ESTAIR) – Phase 2

https://clinicaltrials.gov/ct2/show/study/NCT02345070

Sponsored by Sanofi — SAR156597 is a bispecific monoclonal antibody against interleukin (IL)-4 and IL-13, two molecules that have been implicated as mediators of IPF development that is administered by subcutaneous injection either once weekly or once every two weeks.

Study Locations:  ONGOING BUT NO LONGER RECRUITING Vancouver, BC; Edmonton, AB; and Toronto, ON.

Nintedanib in Combination With Pirfenidone in IPF
Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF – Phase 4

https://clinicaltrials.gov/ct2/show/study/NCT02579603

Sponsored by Boehringer Ingelheim — Nintedanib and Pirfenidone are anti-fibrotic drugs that are administered orally. 2 arms: Nintendanib alone and Nintedanib + Pirfenidone

Study Locations:  ONGOING BUT NO LONGER RECRUITING Winnipeg, MB and Vancouver, BC.

PBI-4050 for Patients with IPF
A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF) – Phase 2

https://clinicaltrials.gov/ct2/show/study/NCT02538536

Sponsored by ProMetic BioSciences Inc. — PBI-4050 is an anti-fibrotic that is administered orally.

Study Locations (updated Oct 13/16):  ONGOING BUT NO LONGER RECRUITING Vancouver, BC;  Toronto, ON; Montreal and Sherbrooke, QC; and Halifax, NS are recruiting.  Check back here or at the link above as 3 other Canadian sites are anticipated.

Lebrikizumab for Patients with IPF
A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis – Phase 2

http://clinicaltrials.gov/ct2/show/NCT01872689?term=lebrikizumab+IPF&rank=1

Sponsored by Hoffmann-La Roche — Lebrikizumab is an antibody that is dissolved in solution like water that can be injected under your skin. It attaches to interlukin-13 (IL-13); it is believed that IL-13 may play a role in IPF. The study is looking at whether blocking IL-13 will slow the progression of the disease.

This is now a combination therapy trial with 4 arms.  Treatment A = Lebrikizumab and Treat B = Pirfenidone + Lebrikizumab with each treatment arm having a complementary placebo arm.

Study Locations (updated Sep 2016): (Completed) Vancouver, BC  (Active, not recruiting) London, ON; Hamilton, ON; Ste. Foy, QC.  (Terminated) Moncton, NB 

Efficacy and Safety of Nintedanib
Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) – Phase 3

https://clinicaltrials.gov/ct2/show/study/NCT02999178

Sponsored by Boehringer Ingelheim

Study Locations (as of Mar. 8, 2017):  (Recruiting) Winnipeg, MB; Hamilton, ON (Not yet recruiting)  Toronto, ON; Sherbrooke, QC.

Nintedanib for Patients with (SSc-ILD)
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis (SSc-ILD or Systemic Sclerosis related ILD) – Phase 3

https://clinicaltrials.gov/ct2/show/study/NCT02597933

Sponsored by Boehringer Ingelheim — 150 mg capsule twice a day.

Study Locations as of Jun. 12, 2017:  (Recruiting) Edmonton, AB; Hamilton, ON; Toronto; ON; Montreal, QC  (Not yet recruiting) Windsor, ON; London, ON

Abituzumab in SSc-ILD)
Abituzumab in Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) – Phase 2

https://clinicaltrials.gov/ct2/show/study/NCT02745145

Sponsored by EMD Serono Research & Development Institute, Inc.
Collaborator Merck KGaA

The purpose of this trial is to compare two doses of abituzumab with placebo and determine whether abituzumab is more effective, safer, will be better tolerated and can provoke better immune response than placebo in the treatment of patients with SSc-ILD who already receive constant doses of mycophenolate.

Intravenous infusion over approximately 1 hour every 4 weeks for 104 weeks with either 1500 mg Abituzumab or 500 mg Abituzumab or placebo

Study Locations as of Aug. 9, 2016:  (Not yet recruiting) Vancouver, BC; Toronto, ON