Clinical trial NCT05022784: Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients
Official title: Real-World Medication Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-08-26
Enrollment: 1798
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study sample will consist of community-dwelling Medicare beneficiaries with Idiopathic Pulmonary Fibrosis (IPF) who initiate treatment with nintedanib.

Brief summary: This is a non-interventional cohort study using existing administrative data from the U.S. Medicare program.

This study has two objectives:

* Identification of adherence trajectories of nintedanib among Idiopathic Pulmonary Fibrosis (IPF) patients.
* Understanding characteristics of patients within each nintedanib adherence trajectory among IPF patients.


Eligibility criteria: Inclusion criteria:

* Newly initiated nintedanib during 10/01/2014 to 12/31/2018
* Were at least 66 years old as of the date of their first nintedanib prescription claim (index date)
* Qualified for Medicare based on age
* Had at least 12 months (365 days) of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months (360 days) after the index date (follow-up period)
* Had at least one inpatient or two outpatient claims (\>14 days apart) with a diagnosis code for Idiopathic Pulmonary Fibrosis (IPF) during the baseline period

Exclusion criteria:

* Had any history of pirfenidone or nintedanib use during the baseline period
* Had any history of lung transplant during the baseline, index date or follow-up periods
* Had any claims for skilled nursing facility, long-term care facility or hospice during the baseline, index date or follow-up period
* Had evidence during the baseline period of any of the following conditions: lung cancer, autoimmune, or connective tissue diseases (i.e. rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's, and mixed connective tissue disease (CTD)) during the baseline period
* Had dual eligibility of Medicare and Medicaid
* Had history of using pirfenidone at the same time with nintedanib during follow-up

Primary outcomes:
measure: Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis (IPF) Patients
timeFrame: Up to 1 year
Secondary outcomes:
measure: Demographic Characteristic: Age According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Demographic Characteristic: Sex According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.
measure: Demographic Characteristic: Race/Ethnicity According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.
measure: Demographic Characteristic: Census Region According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.
measure: Demographic Characteristic: Social Deprivation Index According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Data collected at the study index date, i.e., the date of the patient's first claim for nintedanib.
measure: Clinical Characteristic: Combined Comorbidity Index According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic: Combined Comorbidity Index According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic: Congestive Heart Failure According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic: Renal Failure According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Data collected at Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic: Cardiac Arrhythmias According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic: Peripheral Vascular Disease According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic: Hypertension According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic- IPF Comorbid Conditions: Asthma According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic- IPF Comorbid Conditions: Chronic Obstructive Pulmonary Disease According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic- IPF Comorbid Conditions: Gastroesophageal Reflux Disease According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic- IPF Comorbid Conditions: Hypoxia According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic- IPF Comorbid Conditions: Pulmonary Hypertension According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic- IPF Comorbid Conditions: Sleep Apnea According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic- IPF Medical Services: High-res CT (High-resolution Computed Tomography) Scan According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic- IPF Medical Services: Lung Biopsy According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Clinical Characteristic- IPF Medical Services: Oxygen Therapy or Supplemental Oxygen According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Baseline HCRU (Health Care Resource Utilization) and Spending: Medication Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Baseline HCRU (Health Care Resource Utilization) and Spending: Pharmacy Spending According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Baseline HCRU (Health Care Resource Utilization) and Spending: Pharmacy Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hospitalization According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hosp - Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics -Inpatient Hospitalization Use and Spending: Inpatient Hosp - LOS According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hosp. Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Inpatient Hospitalization Use and Spending: Inpatient Hosp. Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Outpatient Facility Use and Spending: Outpatient Facility - Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics: Outpatient Facility Use and Spending: Outpatient Facility Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Outpatient Facility Use and Spending: Outpatient Facility Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics -Home Health Use and Spending: Home Health - Count According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Home Health Use and Spending: Home Health Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Part B Spending: Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics -Part B Spending: Part B Spending - OOP: According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Total Spending: Total Medical Spending According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Total Spending: All Spending - Total According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
measure: Beneficiary Characteristics - Total Spending: All Spending - OOP According to Adherence Trajectories for the Idiopathic Pulmonary Fibrosis (IPF) Patients Who Were Initiated on Nintedanib
timeFrame: Baseline period: 360 consecutive days ending the day before the index date (i.e., the date of the patient's first claim for nintedanib). Up to 360 days.
Other outcomes:
Locations:
city: Milton
country: United States
facility: Medicus Economics, LCC
state: Massachusetts
Study officials:
References: