Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.
Interventions
DRUGNintedanib
Nintedanib
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who have been started on Ofev in accordance with the approved label in Korea * Patients who have signed on the data release consent form
Exclusion criteria
* Patients for whom nintedanib is contraindicated according local label of Ofev * Patients with known hypersensitivity to Ofev, peanut or soya, or to any of the excipients * Women who are pregnant or nursing * Patients with moderate(Child pugh B) and severe(Child Pugh c) hepatic impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events Who Took at Least One Dose of Ofev | Up to 24 weeks. | Number of patients with adverse events who took at least one dose of Ofev is presented. |
| Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment | At baseline and at week 12. | 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. |
| Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment | At baseline and at week 24. | 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. |
Countries
South Korea
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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)) | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Not treated with Ofev | 2 |
| Overall Study | Off-label use | 2 |
Baseline characteristics
| Characteristic | Ofev Treatment | — |
|---|---|---|
| Age, Continuous | 67.71 Years STANDARD_DEVIATION 9 | — |
| Forced Vital Capacity (FVC) at baseline | 2510.00 MilliLitres (mL) STANDARD_DEVIATION 765.29 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 49 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 65 |
| other Total, other adverse events | 17 / 65 |
| serious Total, serious adverse events | 16 / 65 |
Outcome results
Primary
Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ofev Treatment | Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment | -15.00 MilliLitres (mL) | Standard Deviation 270.73 |
p-value: 0.817t-test, 2 sided
Primary
Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ofev Treatment | Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment | -44.00 MilliLitres (mL) | Standard Deviation 299.49 |
p-value: 0.6533t-test, 2 sided
Primary
Number of Patients With Adverse Events Who Took at Least One Dose of Ofev
Number of patients with adverse events who took at least one dose of Ofev is presented.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ofev Treatment | Number of Patients With Adverse Events Who Took at Least One Dose of Ofev | 36 Participants |