Trial · NCT02802345

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

NCT02802345, Phase 3, Completed, Boehringer Ingelheim; results first posted 2019-01-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment. Trials, record NCT02802345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02802345

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment
NCT number: NCT02802345
Status: Completed
Phases: Phase 3
Enrollment: 274 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: Nintedanib, Placebo, Sildenafil
First posted: 2016-06-16
Last updated: 2019-01-11
Other registries' IDs: eudract:2015-002619-14
Results first posted: 2019-01-11

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score at Week 12	Baseline and week 12	The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. Scores range from 0 to 100, with higher scores indicating more limitations. The mean and standard error presented are actually adjusted mean for change from baseline and its standard error.
Secondary	Change From Baseline in Dyspnoea Using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at Week 12	Baseline and week 12	The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.
Secondary	Change From Baseline in SGRQ Total Score at Week 24	Baseline and week 24	The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.
Secondary	Change From Baseline in Dyspnoea Using UCSD SOBQ at Week 24	Baseline and week 24	The UCSD SOBQ is a 24-item questionnaire developed to to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.
Secondary	Percentage of Patients With On-treatment Serious Adverse Events (SAE) From Baseline to Week 24	Baseline and week 24	Percentage of patients with on-treatment serious adverse events (SAE) from baseline to Week 24 is presented.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score at Week 12	Baseline and week 12	TS	Unit on scale	MEAN
SECONDARY	Change From Baseline in Dyspnoea Using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at Week 12	Baseline and week 12	Treated Set (TS): TS included all patients who were randomised to a treatment group and received at least one dose of randomised study medication.	Unit on scale	MEAN
SECONDARY	Change From Baseline in SGRQ Total Score at Week 24	Baseline and week 24	TS	Unit on scale	MEAN
SECONDARY	Change From Baseline in Dyspnoea Using UCSD SOBQ at Week 24	Baseline and week 24	TS	Unit on scale	MEAN
SECONDARY	Percentage of Patients With On-treatment Serious Adverse Events (SAE) From Baseline to Week 24	Baseline and week 24	TS	Percentage of participants (%)	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score at Week 12	Nintedanib+Placebo	-0.77	Standard Error 1.009	Unit on scale
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score at Week 12	Nintedanib+Sildenafil	-1.28	Standard Error 1.013	Unit on scale
Change From Baseline in Dyspnoea Using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at Week 12	Nintedanib+Placebo	4.40	Standard Deviation 1.529	Unit on scale
Change From Baseline in Dyspnoea Using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at Week 12	Nintedanib+Sildenafil	1.46	Standard Deviation 1.575	Unit on scale
Change From Baseline in SGRQ Total Score at Week 24	Nintedanib+Placebo	2.42	Standard Deviation 1.158	Unit on scale
Change From Baseline in SGRQ Total Score at Week 24	Nintedanib+Sildenafil	0.23	Standard Deviation 1.148	Unit on scale
Change From Baseline in Dyspnoea Using UCSD SOBQ at Week 24	Nintedanib+Placebo	6.85	Standard Deviation 1.791	Unit on scale
Change From Baseline in Dyspnoea Using UCSD SOBQ at Week 24	Nintedanib+Sildenafil	4.44	Standard Deviation 1.779	Unit on scale
Percentage of Patients With On-treatment Serious Adverse Events (SAE) From Baseline to Week 24	Nintedanib+Placebo	32.4		Percentage of participants (%)
Percentage of Patients With On-treatment Serious Adverse Events (SAE) From Baseline to Week 24	Nintedanib+Sildenafil	27.0		Percentage of participants (%)

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nintedanib+Placebo	136
Overall Study	STARTED	Nintedanib+Sildenafil	138
Overall Study	Treated	Nintedanib+Placebo	136
Overall Study	Treated	Nintedanib+Sildenafil	137
Overall Study	COMPLETED	Nintedanib+Placebo	104
Overall Study	COMPLETED	Nintedanib+Sildenafil	108
Overall Study	NOT COMPLETED	Nintedanib+Placebo	32
Overall Study	NOT COMPLETED	Nintedanib+Sildenafil	30

Source ClinicalTrials.gov

Adverse events222

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Nintedanib+Placebo	9	136
other	Abdominal pain	Gastrointestinal disorders	Nintedanib+Sildenafil	4	137
other	Abdominal pain upper	Gastrointestinal disorders	Nintedanib+Placebo	7	136
other	Abdominal pain upper	Gastrointestinal disorders	Nintedanib+Sildenafil	6	137
other	Constipation	Gastrointestinal disorders	Nintedanib+Placebo	8	136
other	Constipation	Gastrointestinal disorders	Nintedanib+Sildenafil	3	137
other	Diarrhoea	Gastrointestinal disorders	Nintedanib+Placebo	66	136
other	Diarrhoea	Gastrointestinal disorders	Nintedanib+Sildenafil	79	137
other	Dyspepsia	Gastrointestinal disorders	Nintedanib+Placebo	4	136
other	Dyspepsia	Gastrointestinal disorders	Nintedanib+Sildenafil	9	137

1 to 10 of 222Source ClinicalTrials.gov

See all 222 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nintedanib+Placebo	12	136
Total, all-cause mortality	Nintedanib+Sildenafil	12	137
Total, other adverse events	Nintedanib+Placebo	113	136
Total, other adverse events	Nintedanib+Sildenafil	118	137
Total, serious adverse events	Nintedanib+Placebo	44	136
Total, serious adverse events	Nintedanib+Sildenafil	37	137

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30220235	DERIVED	PubMed
31365829	DERIVED	PubMed
31914963	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Nintedanib+Placebo vs Nintedanib+Sildenafil: deaths from any cause	Trial comparisons
Nintedanib+Placebo vs Nintedanib+Sildenafil: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02802345

GET https://conductscience.org/api/trials/v1/NCT02802345/events?page=2

API reference For AI assistants