Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT05022784
Collaborator
(none)
1,500
1
4.2
353.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
1500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Real-World Medication Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients
Actual Study Start Date :
Aug 23, 2021
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Idiopathic Pulmonary Fibrosis Patients

Medicare beneficiaries with IPF who newly initiated treatment with nintedanib

Drug: Nintedanib
Nintedanib

Outcome Measures

Primary Outcome Measures

  1. Adherence trajectories based on monthly proportion of days covered (PDC) [up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
66 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medicus Economics, LCC Milton Massachusetts United States 02186

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05022784
Other Study ID Numbers:
  • 1199-0471
First Posted:
Aug 26, 2021
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022