Trial Outcomes & Findings for Safety and Effectiveness of Nintedanib in Korean Patients (NCT NCT04525547)
NCT ID: NCT04525547
Last Updated: 2024-03-12
Results Overview
Change from baseline in Forced Vital Capacity) (FVC) (mL) after 24 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation.
COMPLETED
70 participants
At baseline and at week 24.
2024-03-12
Participant Flow
The objective of this non-interventional, multi-center study was to monitor the safety profile and effectiveness of Ofev in Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype in routine clinical settings based on new collected data.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Ofev Treatment
Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID))
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Ofev Treatment
Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID))
|
|---|---|
|
Overall Study
Not treated with Ofev
|
2
|
|
Overall Study
Off-label use
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ofev Treatment
n=65 Participants
Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID))
|
|---|---|
|
Age, Continuous
|
67.71 Years
STANDARD_DEVIATION 9.00 • n=65 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=65 Participants
|
|
Forced Vital Capacity (FVC) at baseline
|
2510.00 MilliLitres (mL)
STANDARD_DEVIATION 765.29 • n=20 Participants • The effectiveness set included safety set who were evaluated for the effectiveness including overall effectiveness evaluation.
|
PRIMARY outcome
Timeframe: Up to 24 weeks.Population: The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
Number of patients with adverse events who took at least one dose of Ofev is presented.
Outcome measures
| Measure |
Ofev Treatment
n=65 Participants
Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID))
|
|---|---|
|
Number of Patients With Adverse Events Who Took at Least One Dose of Ofev
|
36 Participants
|
PRIMARY outcome
Timeframe: At baseline and at week 12.Population: The effectiveness set included safety set who were evaluated for the effectiveness including overall effectiveness evaluation. Only participants with non-missing results were included in the analysis.
Change from baseline in Forced Vital Capacity) (FVC) (mL) after 12 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation.
Outcome measures
| Measure |
Ofev Treatment
n=18 Participants
Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID))
|
|---|---|
|
Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment
|
-15.00 MilliLitres (mL)
Standard Deviation 270.73
|
PRIMARY outcome
Timeframe: At baseline and at week 24.Population: The effectiveness set included safety set who were evaluated for the effectiveness including overall effectiveness evaluation. Only participants with non-missing results were included in the analysis.
Change from baseline in Forced Vital Capacity) (FVC) (mL) after 24 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation.
Outcome measures
| Measure |
Ofev Treatment
n=10 Participants
Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID))
|
|---|---|
|
Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment
|
-44.00 MilliLitres (mL)
Standard Deviation 299.49
|
Adverse Events
Ofev Treatment
Serious adverse events
| Measure |
Ofev Treatment
n=65 participants at risk
Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID))
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
9.2%
6/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
2/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.5%
1/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
COVID-19
|
3.1%
2/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
General disorders
Asthenia
|
1.5%
1/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
General disorders
Generalised oedema
|
1.5%
1/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.5%
1/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.5%
1/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
1.5%
1/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Renal and urinary disorders
Calculus urinary
|
1.5%
1/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Investigations
Weight decreased
|
1.5%
1/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
Other adverse events
| Measure |
Ofev Treatment
n=65 participants at risk
Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID))
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
10/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
4/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
5/65 • Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER