Clinical trial NCT05676112: Safety of Nintedanib in Real World in China
Official title: Safety of Nintedanib in Real World in China: a Non-interventional Study Based on Idiopathic Pulmonary (Interstitial) Fibrosis Registry China Study (PORTRAY) Data
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: China-Japan Friendship Hospital
First posted: 2023-01-09
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Idiopathic pulmonary fibrosis (IPF) patients in China:

Patients who initiate nintedanib during the study (group 1). The index date for this group of patients is defined as the day when a patient initiates nintedanib; Patients who initiate pirfenidone during the study (group 2). The index date for this group of patients is defined as the day when a patient initiates pirfenidone; Patients who receive neither nintedanib nor pirfenidone (group 3). To define the index date for this group of patients, we will first calculate the average number of days between the first diagnosis of IPF and the day when nintedanib is initiated in group 1 patients (Xn). The index date for group 3 patients is defined as Xn days after the first diagnosis of IPF of a patient.

Brief summary: The main objective of this study is to evaluate the incidence rates of adverse drug reactions (ADRs) and fatal adverse events (AEs) among idiopathic pulmonary fibrosis (IPF) patients in China who initiate nintedanib during the study period.


Eligibility criteria: Inclusion Criteria:

* Patients who initiate nintedanib during the study period
* Patients who initiate pirfenidone during the study period
* Patients who use neither nintedanib nor pirfenidone
* Patients who were diagnosed with IPF according to the 2011 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines in the past 3 months before recruitment
* Patients who are 40 years old and above when enrolled
* Patients who are willing to participate in the study and sign the informed consent form

Primary outcomes:
measure: Incidence rate of adverse drug reactions (ADRs) during entire follow-up period
timeFrame: During entire follow-up period, up to 1 year
measure: Incidence rate of adverse drug reactions (ADRs) during the 1-year follow-up period after the index date
timeFrame: During follow-up period after index date, up to 1 year
measure: Incidence rate of fatal adverse events (AEs) during entire follow-up period
timeFrame: During entire follow-up period, up to 1 year
measure: Incidence rate of fatal adverse events (AEs) during the 1-year follow-up period after the index date
timeFrame: During follow-up period after index date, up to 1 year
Secondary outcomes:
measure: Mean age at baseline of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug
timeFrame: At baseline
measure: Percentage of each gender of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug
timeFrame: At baseline
Other outcomes:
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