Idiopathic Pulmonary FibrosisNCT05870956
Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients
An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
This study has two objectives: 1. To assess the association between nintedanib adherence trajectory group (as measured from a Group-based Trajectory Modelling (GBTM)) and health care resource use, with a focus on inpatient hospitalization, among patients with Idiopathic Pulmonary Fibrosis (IPF). 2. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Nintedanib
- How many people
- 1,798 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to 30 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: IPF patients in United States which were newly initiated on nintedanib during 10-Jan-2014 to 31-Dec-2018.
Who may be able to join
- 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 of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months after the index date (follow-up period)
- Had at least one inpatient or two outpatient claims (>14 days apart) with a diagnosis code for IPF (ICD-10-CM: J84.112; ICD-9-CM: 516.31) during the baseline period
Who cannot join
- 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 (≥2 ICD-9-CM or ICD-10-CM diagnosis codes on different dates) 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Economic Burden Associated With Nintedanib Non-adherence Among Medicare Beneficiaries With IPF
This study has two objectives:
- To assess the association between nintedanib adherence trajectory group (as measured from a Group-based Trajectory Modelling (GBTM)) and health care resource use, with a focus on inpatient hospitalization, among patients with Idiopathic Pulmonary Fibrosis (IPF).
- To assess the association between a patient's nintedanib adherence trajectory group (as measured from a GBTM) and their medical costs among patients with IPF.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Nintedanib
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
Also called Ofev®
Nintedanib
| Study group | Role | What they receive |
|---|---|---|
| High nintedanib adherence | Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high adherence group presented a mean adherence estimate of 0.96 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation. Receives: Drug: Nintedanib | |
| Moderate nintedanib adherence | Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in moderate adherence group presented a mean adherence estimate of 0.71 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation. Receives: Drug: Nintedanib | |
| High-then-poor nintedanib adherence | Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high-then-poor adherence group presented a mean adherence estimate of 0.74 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 7 months followed by a sharp decline. Receives: Drug: Nintedanib | |
| Delayed-poor nintedanib adherence | Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in delayed poor adherence group presented a mean adherence estimate of 0.36 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 2 months followed by a constant decline. Receives: Drug: Nintedanib | |
| Early-poor nintedanib adherence | Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in early-poor adherence group presented a mean adherence estimate of 0.13 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first month followed by a sharp decline. Receives: Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total All-cause Medical Costs
Total all-cause medical costs per patient calculated as the sum of the total amounts paid for all medical services by the payer and the patient. The types of medical services covered by Medicare included inpatient facility, outpatient facility, skilled nursing facility, home health care, hospice, durable medical equipment, clinician office visits, and other physician services covered under the Part B benefit. The costs with prescriptions covered under Part D benefit were excluded from this outcome analysis.
Measured: At day 360 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
Secondary outcomes (3)
Total IPF-related Medical Costs
The total Idiopathic Pulmonary Fibrosis (IPF) related medical costs per patient were calculated as the sum of the total amounts paid by the payers and the patients for all medical services for an IPF-related reason containing at least one IPF diagnosis code.
Measured: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
All-cause Inpatient Hospitalization
Percentage of patients with at least one inpatient hospitalization for any cause in the first year of nintedanib initiation. Percentages were rounded to one decimal place.
Measured: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
IPF-related Inpatient Hospitalization
Percentage of patients with at least one inpatient hospitalization for any Idiopathic Pulmonary Fibrosis (IPF)-related cause in the first year of nintedanib initiation. Percentages were rounded to one decimal place.
Measured: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start16 May 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,798 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870956
- Sponsor's protocol ID
- 1199-0520
- Status last verified
- Jun 2024
- First submitted
- 15 May 2023
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Burden Associated With Nintedanib Non-adherence Among Medicare Beneficiaries With IPF
- ClinicalTrials.gov ID
- NCT05870956
- Acronym / sponsor ID
- 1199-0520
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,798 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has two objectives:
- To assess the association between nintedanib adherence trajectory group (as measured from a Group-based Trajectory Modelling (GBTM)) and health care resource use, with a focus on inpatient hospitalization, among patients with Idiopathic Pulmonary Fibrosis (IPF).
- To assess the association between a patient's nintedanib adherence trajectory group (as measured from a GBTM) and their medical costs among patients with IPF.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| High nintedanib adherence | – | Drug: NintedanibCommunity-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high adherence group presented a mean adherence estimate of 0.96 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation. |
| Moderate nintedanib adherence | – | Drug: NintedanibCommunity-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in moderate adherence group presented a mean adherence estimate of 0.71 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation. |
| High-then-poor nintedanib adherence | – | Drug: NintedanibCommunity-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in high-then-poor adherence group presented a mean adherence estimate of 0.74 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 7 months followed by a sharp decline. |
| Delayed-poor nintedanib adherence | – | Drug: NintedanibCommunity-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in delayed poor adherence group presented a mean adherence estimate of 0.36 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first 2 months followed by a constant decline. |
| Early-poor nintedanib adherence | – | Drug: NintedanibCommunity-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with 66 years of age or older at the time of the first nintedanib prescription (between 01-Oct-2014 and 31-Oct-2018), and continuous Medicare hospital (Part A), physician (Part B) and pharmacy (Part D) coverage (between 01-Oct-2013 to 31-12-2020). Patients in early-poor adherence group presented a mean adherence estimate of 0.13 (proportion of days covered - PDC) in a period of 12 months after nintedanib first initiation, with a high adherence in the first month followed by a sharp decline. |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- IPF patients in United States which were newly initiated on nintedanib during 10-Jan-2014 to 31-Dec-2018.
Key inclusion criteria (5 listed)
- 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 of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months after the index date (follow-up period)
- Had at least one inpatient or two outpatient claims (>14 days apart) with a diagnosis code for IPF (ICD-10-CM: J84.112; ICD-9-CM: 516.31) during the baseline period
Key exclusion criteria (6 listed)
- 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 (≥2 ICD-9-CM or ICD-10-CM diagnosis codes on different dates) 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NintedanibAlso: Ofev®Nintedanib | Drug | Delayed-poor nintedanib adherence, Early-poor nintedanib adherence, High nintedanib adherence, High-then-poor nintedanib adherence, Moderate nintedanib adherence |
Primary outcome
Total All-cause Medical Costs
Time frame: At day 360 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
Total all-cause medical costs per patient calculated as the sum of the total amounts paid for all medical services by the payer and the patient. The types of medical services covered by Medicare included inpatient facility, outpatient facility, skilled nursing facility, home health care, hospice, durable medical equipment, clinician office visits, and other physician services covered under the Part B benefit. The costs with prescriptions covered under Part D benefit were excluded from this outcome analysis.
3 secondary outcomes
Total IPF-related Medical Costs
Time frame: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
All-cause Inpatient Hospitalization
Time frame: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
IPF-related Inpatient Hospitalization
Time frame: At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total All-cause Medical Costs (time frame: At day 360 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.