Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension
CompletedPhase 2Results postedLast updated 12 November 2020
What this trial tests
Phase 2 trial testing Pirfenidone in Idiopathic Pulmonary Fibrosis in 177 participants. Completed in 22 August 2020.
Adults 40 to 80, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Disease Progression, as Determined by Relevant Decline in 6 Minute Walk Distance (6MWD) of At Least (>=) 15 Percent (%) From Baseline, Respiratory-Related Non-Elective Hospitalization, or Death From Any CausePrimary· Baseline up to Week 52
Disease Progression defined as relative decline in 6-minute walking distance (6MWD) from baseline (defined as \>25% from baseline or 15-25% from baseline associated with worsening oxygen saturation, worsening Borg score, or increased oxygen requirements), respiratory-related non-elective hospitalizations, or all-cause mortality.
Group
Value
95% CI
Pirfenidone+Sildenafil
72.7
Pirfenidone+Placebo
69.7
Time to First Occurrence of Disease ProgressionSecondary· Baseline up to Week 52
Disease Progression defined as relative decline in 6MWD from baseline (defined as \>25% from baseline or 15-25% from baseline associated with worsening oxygen saturation, worsening Borg score, or increased oxygen requirements), respiratory-related non-elective hospitalizations, or all-cause mortality.
Group
Value
95% CI
Pirfenidone+Sildenafil
26.00
20.57 – 38.14
Pirfenidone+Placebo
25.43
13.00 – 37.71
Time to Multiple Occurrence of Disease Progression EventsSecondary· Baseline up to Week 52
Disease Progression defined as relative decline in 6MWD from baseline (defined as \>25% from baseline or 15-25% from baseline associated with worsening oxygen saturation, worsening Borg score, or increased oxygen requirements), respiratory-related non-elective hospitalizations, or all-cause mortality. In case participant had more than one event as described in the endpoint definition the second, third etc event was counted as well for the calculation of the endpoint.
Group
Value
95% CI
Pirfenidone+Sildenafil
20.57
13.14 – 26.43
Pirfenidone+Placebo
13.29
12.71 – 23.29
Percentage of Participants With Decline From Baseline in 6-minute Walking Distance (6MWD) of >= 15%Secondary· Baseline up to Week 52
Group
Value
95% CI
Pirfenidone+Sildenafil
53.4
Pirfenidone+Placebo
50.6
Time to First Occurrence of Relevant ≥15% Decline From Baseline in 6-minute Walking Distance (6MWD)Secondary· Baseline up to Week 52
Group
Value
95% CI
Pirfenidone+Sildenafil
39.00
27.86 – 52.14
Pirfenidone+Placebo
38.71
25.14 – 52.57
Time to Respiratory-Related Non-Elective Hospitalization From Baseline to Week 52Secondary· Baseline up to Week 52
N.A. = non-calculable
Group
Value
95% CI
Pirfenidone+Sildenafil
54.29
36.29 – NA
Pirfenidone+Placebo
NA
42.14 – NA
Time to All-Cause Non-Elective HospitalizationSecondary· Baseline up to Week 52
N.A. = non-calculable
Group
Value
95% CI
Pirfenidone+Sildenafil
47.57
28.00 – NA
Pirfenidone+Placebo
49.86
32.00 – NA
Time to Death From Any CauseSecondary· Baseline up to Week 52
Group
Value
95% CI
Pirfenidone+Sildenafil
NA
54.43 – NA
Pirfenidone+Placebo
NA
NA – NA
Percentage of Participants With Lung TransplantationSecondary· Baseline up to Week 52
Group
Value
95% CI
Pirfenidone+Sildenafil
10.2
Pirfenidone+Placebo
6.7
Time to Respiratory-Related DeathSecondary· Baseline up to Week 52
Group
Value
95% CI
Pirfenidone+Sildenafil
NA
54.43 – NA
Pirfenidone+Placebo
NA
NA – NA
Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Peak Tricuspid Regurgitation VelocitySecondary· Baseline, Week 52
Group
Value
95% CI
Pirfenidone+Sildenafil
-0.014
± 0.6326
Pirfenidone+Placebo
0.103
± 0.6699
Change From Baseline to Week 52 in Transthoracic Echocardiography (ECHO) Parameter: Pulmonary Artery Pressure (PAPs)Secondary· Baseline, Week 52
Group
Value
95% CI
Pirfenidone+Sildenafil
2.0
± 15.65
Pirfenidone+Placebo
3.6
± 22.38
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline to primary data cut-off (up to 2 years 7 months). The safety data includes DBP and SFU up to 11-Nov-2019..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This Phase IIb, randomized, placebo-controlled, multicenter, international study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone (Esbriet) treatment in participants with advanced IPF and intermediate or high probability of Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone with demonstrated tolerability. Participants will be randomized to receive 1 year of treatment with either oral sildenafil or matching placebo while continuing to take pirfenidone.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in
· Phase 2
· recruiting
NCT07082842 — Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF
· Phase 3
· not yet recruiting
NCT07015398 — A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in
· Phase 1
· completed
NCT06485635 — Real-life-persistence to Antifibrotic Treatments
· completed
NCT06484153 — Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcin
· Phase 1, PHASE2
· not yet recruiting
Other recruiting trials for Idiopathic Pulmonary Fibrosis
Currently open trials in the same condition.
NCT05988463 — Dose-Escalation Study of Artesunate Patients With IPF
· Phase 1
· recruiting
NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in
· Phase 2
· recruiting
NCT07407543 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Cauc
· Phase 1
· recruiting
NCT07036523 — A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
· Phase 2
· recruiting
NCT07225296 — A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics o
· Phase 1
· recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O
· Phase 2
· not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in
· Phase 3
· recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations
· not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
· Phase 3
· recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric
· Phase 3
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 12 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02951429.