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Tyrosine Kinase Inhibitor

Nintedanib + Sildenafil for Idiopathic Pulmonary Fibrosis

Phase 3
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 24
Awards & highlights

Summary

To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.

Eligible Conditions
  • Idiopathic Pulmonary Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score at Week 12
Secondary outcome measures
Change From Baseline in Dyspnoea Using UCSD SOBQ at Week 24
Change From Baseline in Dyspnoea Using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at Week 12
Change From Baseline in SGRQ Total Score at Week 24
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nintedanib + placebo matching sildenafilExperimental Treatment2 Interventions
Group II: Nintedanib + SildenafilActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Nintedanib
FDA approved

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,516 Previous Clinical Trials
11,347,072 Total Patients Enrolled
49 Trials studying Idiopathic Pulmonary Fibrosis
45,107 Patients Enrolled for Idiopathic Pulmonary Fibrosis
~30 spots leftby Sep 2025