Idiopathic Pulmonary FibrosisNCT03281200
Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain
An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 1 site in Spain.
Trial summary
The present study has been designed to characterize IPF patients treated with nintedanib (OFEV®), at time of treatment initiation, with respect to their clinical profile based on real-world data from January 2016 in Spanish Pulmonology Services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- L - Antineoplastic and immunomodulating agents, L01 - Antineoplastic agents and L01X - Other antineoplastic agents
- How many people
- 172 participants
- Where
- 1 siteSpain
- Study dates
- 24 Oct 2017to 7 Jun 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 175 IPF patients from 35 Pulmonology Services in Spain are planned to be included in the study.
Who may be able to join
- The patient is at least 18 years old
- The patient has IPF diagnosis according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management [5]
- The patient newly initiated treatment with nintedanib (OFEV®) since 01 January 2016 up to end of data collection date, according to the approved local Summary of Product Characteristics (SmPC)
Who cannot join
- Patients treated with nintedanib within a clinical trial or named-patient program or with any prior treatment of nintedanib.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Retrospective Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain.
The present study has been designed to characterize IPF patients treated with nintedanib (OFEV®), at time of treatment initiation, with respect to their clinical profile based on real-world data from January 2016 in Spanish Pulmonology Services.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- L - Antineoplastic and immunomodulating agents, L01 - Antineoplastic agents, L01X - Other antineoplastic agents, L01XE - Protein kinase inhibitors, L01XE31 - 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.
L - Antineoplastic and immunomodulating agentsDrug
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agentsDrug
L01 - Antineoplastic agents
L01X - Other antineoplastic agentsDrug
L01X - Other antineoplastic agents
L01XE - Protein kinase inhibitorsDrug
L01XE - Protein kinase inhibitors
L01XE31 - NintedanibDrug
Also called OVEF
L01XE31 - Nintedanib
| Study group | Role | What they receive |
|---|---|---|
| Anatomical main group: | Not described Receives: Drug: L - Antineoplastic and immunomodulating agents | |
| Therapeutic subgroup | Not described Receives: Drug: L01 - Antineoplastic agents | |
| Pharmacological subgroup | Not described Receives: Drug: L01X - Other antineoplastic agents | |
| Chemical subgroup | Not described Receives: Drug: L01XE - Protein kinase inhibitors | |
| Chemical substance | Not described Receives: Drug: L01XE31 - Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))
The distribution of patients across different lung function categories (% FVC serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))
The distribution of patients across different lung function categories (% DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Secondary outcomes (17)
The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation
The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Duration of the Disease
Duration of the disease of IPF patients, calculated as the time elapsed from the date of diagnosis until the start date of treatment with OFEV® (years).
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With Emphysema
The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern
The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern
The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®
The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy
The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy
The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy
The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Demographic Baseline Characteristics - 6-minute Walk Test
The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit
The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea
The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations
The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments
The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.
The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.
The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)
The distribution of patients across different lung function categories based on the reimbursement threshold (FVC >80%, 50-80%, and <50%).
Measured: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start24 Oct 2017
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 172 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
- NCT03281200
- Sponsor's protocol ID
- 1199-0295
- Status last verified
- Jun 2019
- First submitted
- 11 Sep 2017
- Last updated
- 1 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Retrospective Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain.
- ClinicalTrials.gov ID
- NCT03281200
- Acronym / sponsor ID
- 1199-0295
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Posted 1 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study has been designed to characterize IPF patients treated with nintedanib (OFEV®), at time of treatment initiation, with respect to their clinical profile based on real-world data from January 2016 in Spanish Pulmonology Services.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anatomical main group: | – | Drug: L - Antineoplastic and immunomodulating agents |
| Therapeutic subgroup | – | Drug: L01 - Antineoplastic agents |
| Pharmacological subgroup | – | Drug: L01X - Other antineoplastic agents |
| Chemical subgroup | – | Drug: L01XE - Protein kinase inhibitors |
| Chemical substance | – | Drug: L01XE31 - Nintedanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 175 IPF patients from 35 Pulmonology Services in Spain are planned to be included in the study.
Key inclusion criteria (3 listed)
- The patient is at least 18 years old
- The patient has IPF diagnosis according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management [5]
- The patient newly initiated treatment with nintedanib (OFEV®) since 01 January 2016 up to end of data collection date, according to the approved local Summary of Product Characteristics (SmPC)
Key exclusion criteria (1 listed)
- Patients treated with nintedanib within a clinical trial or named-patient program or with any prior treatment of nintedanib.
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 |
|---|---|---|
| L - Antineoplastic and immunomodulating agentsL - Antineoplastic and immunomodulating agents | Drug | Anatomical main group: |
| L01 - Antineoplastic agentsL01 - Antineoplastic agents | Drug | Therapeutic subgroup |
| L01X - Other antineoplastic agentsL01X - Other antineoplastic agents | Drug | Pharmacological subgroup |
| L01XE - Protein kinase inhibitorsL01XE - Protein kinase inhibitors | Drug | Chemical subgroup |
| L01XE31 - NintedanibAlso: OVEFL01XE31 - Nintedanib | Drug | Chemical substance |
Primary outcome
Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The distribution of patients across different lung function categories (% FVC serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.
Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The distribution of patients across different lung function categories (% DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.
17 secondary outcomes
The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Duration of the Disease
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With Emphysema
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Demographic Baseline Characteristics - 6-minute Walk Test
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)
Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 Spain.
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 3 inclusion and 1 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 Aug 2019. 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 Spain. 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 Aug 2019). 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?
Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity)) (time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.). The study lists 2 primary outcomes in all. 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 Aug 2019.