Trial · NCT01335477

Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II

NCT01335477, Phase 3, Completed, Boehringer Ingelheim; results first posted 2015-02-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II. Trials, record NCT01335477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01335477

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Trial

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

Title: Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II
NCT number: NCT01335477
Status: Completed
Phases: Phase 3
Enrollment: 551 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Pulmonary Fibrosis
Interventions: placebo, BIBF 1120
First posted: 2011-04-14
Last updated: 2016-07-25
Other registries' IDs: eudract:2010-024252-29
Results first posted: 2015-02-13

Source ClinicalTrials.gov

Registered outcomes29

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

List	Outcome	Time frame	Description
Primary	Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.	52 weeks	Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.
Secondary	Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks	Baseline and 52 weeks	This is a key secondary endpoint. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52).
Secondary	Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation	52 weeks	Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows: Otherwise unexplained clinical features including all of the following: Unexplained worsening or development of dyspnoea within 30 days New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit Exclusion of infection as per routine clinical practice and microbiological studies Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury. Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs .
Secondary	Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks	Baseline and 52 weeks	Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).
Secondary	Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks	Baseline and 52 weeks	Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).
Secondary	Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks	Baseline and 52 weeks	Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).
Secondary	Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks	Baseline and 52 weeks	Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).
Secondary	Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold	Baseline and 52 weeks	Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by \>5%, increase by \>5%, and change within ≤5%).
Secondary	Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold	Baseline and 52 weeks	Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by \>10%, and change within ≤10%)
Secondary	FVC Responders Using 10% Threshold at 52 Weeks	52 weeks	FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks.

1 to 10 of 29Source ClinicalTrials.gov

See all 29 registered outcomes

Outcomes29

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.	52 weeks	Treated Set	mL/year	MEAN
SECONDARY	Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks	Baseline and 52 weeks	Treated Set (Only patients with observed cases (OC) values were analysed)	points on a scale	MEAN
SECONDARY	Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation	52 weeks	Treated Set	percentage of participants	NUMBER
SECONDARY	Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks	Baseline and 52 weeks	Treated Set (Only patients with observed cases (OC) values were analysed)	mL	MEAN
SECONDARY	Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks	Baseline and 52 weeks	Treated Set (Only patients with observed cases (OC) values were analysed)	percent change	MEAN
SECONDARY	Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks	Baseline and 52 weeks	Treated Set (Only patients with observed cases (OC) values were analysed)	%predicted	MEAN
SECONDARY	Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks	Baseline and 52 weeks	Treated Set (Only patients with observed cases (OC) values were analysed)	percent change	MEAN
SECONDARY	Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold	Baseline and 52 weeks	Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52)	percentage of participants	NUMBER
SECONDARY	Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold	Baseline and 52 weeks	Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52)	percentage of participants	NUMBER
SECONDARY	FVC Responders Using 10% Threshold at 52 Weeks	52 weeks	Treated Set	percentage of participants	NUMBER

1 to 10 of 29Source ClinicalTrials.gov

See all 29 outcomes

Results by group82

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

Outcome	Group	Category	Value	Spread	Units
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.	Placebo		-207.32	Standard Error 19.309	mL/year
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.	Nintedanib 150 mg Bid		-113.59	Standard Error 15.726	mL/year
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks	Placebo		5.48	Standard Error 0.891	points on a scale
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks	Nintedanib 150 mg Bid		2.80	Standard Error 0.730	points on a scale
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation	Placebo	Failure	9.6		percentage of participants
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation	Nintedanib 150 mg Bid	Failure	3.6		percentage of participants
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation	Placebo	Censored	90.4		percentage of participants
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation	Nintedanib 150 mg Bid	Censored	96.4		percentage of participants
Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks	Placebo		-205.03	Standard Error 16.629	mL
Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks	Nintedanib 150 mg Bid		-95.26	Standard Error 14.200	mL

1 to 10 of 82Source ClinicalTrials.gov

See all 82 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	220
Overall Study	STARTED	Nintedanib 150 mg Bid	331
Overall Study	COMPLETED	Placebo	179
Overall Study	COMPLETED	Nintedanib 150 mg Bid	272
Overall Study	NOT COMPLETED	Placebo	41
Overall Study	NOT COMPLETED	Nintedanib 150 mg Bid	59

Source ClinicalTrials.gov

Adverse events350

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	Placebo	7	219
other	Abdominal pain	Gastrointestinal disorders	Nintedanib 150mg Bid	30	329
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	6	219
other	Abdominal pain upper	Gastrointestinal disorders	Nintedanib 150mg Bid	18	329
other	Constipation	Gastrointestinal disorders	Placebo	10	219
other	Constipation	Gastrointestinal disorders	Nintedanib 150mg Bid	19	329
other	Diarrhoea	Gastrointestinal disorders	Placebo	39	219
other	Diarrhoea	Gastrointestinal disorders	Nintedanib 150mg Bid	207	329
other	Nausea	Gastrointestinal disorders	Placebo	16	219
other	Nausea	Gastrointestinal disorders	Nintedanib 150mg Bid	86	329

1 to 10 of 350Source ClinicalTrials.gov

See all 350 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Nintedanib 150mg Bid
Total, other adverse events	Placebo	193	219
Total, other adverse events	Nintedanib 150mg Bid	308	329
Total, serious adverse events	Placebo	72	219
Total, serious adverse events	Nintedanib 150mg Bid	98	329

Source ClinicalTrials.gov

Papers14

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24834811	DERIVED	PubMed
24836310	DERIVED	PubMed
26400368	DERIVED	PubMed
27672117	DERIVED	PubMed
28039616	DERIVED	PubMed
28388260	DERIVED	PubMed
28526798	DERIVED	PubMed
30176872	DERIVED	PubMed
30729456	DERIVED	PubMed
30971229	DERIVED	PubMed

1 to 10 of 14

See all 14 papers

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 comparisons1

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

Comparison
Nintedanib 150mg Bid vs Placebo: serious adverse events

Source 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/NCT01335477

GET https://conductscience.org/api/trials/v1/NCT01335477/registered?page=2

API reference For AI assistants