Idiopathic Pulmonary FibrosisQUALIFY IPFNCT03710824

Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib

An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 10 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Multi-center, non-interventional, prospective cohort study aiming to enroll 240 Idiopathic Pulmonary Fibrosis patients receiving treatment with nintedanib in a consecutive manner from 10-12 reference centers across Greece. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Idiopathic Pulmonary Fibrosis
What is being tested?: Nintedanib
How many people: 180 participants
Where: 10 sitesGreece
Study dates: 28 Feb 2019to 22 Feb 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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Newly diagnosed IPF patients initiating treatment with nintedanib according to their physician's clinical decision will be enrolled in this study. In details, patients will be eligible to enroll in the study if the fulfil all the inclusion criteria.

Who may be able to join

Patients ≥40 years of age.
Patients that have signed Informed Consent Form.
Treatment naive patients with an initial IPF diagnosis no more than 3 months prior to enrolment according to 2011 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines who are initiating treatment with nintedanib (as monotherapy for IPF) the latest on the enrollement day or have initiated treatment with nintedanib (as monotherapy for IPF) within the past 7 days prior to enrolment.
Patients for whom the decision to prescribe therapy with nintedanib according to the locally approved product's Summary of Product Characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study.
Patients that are able to read, understand and complete the study specific questionnaires.

Who cannot join

Treatment with nintedanib for more than 7 days prior to study enrolment.
Patients receiving a combination therapy of nintedanib \& pirfenidone for IPF.
Patients that meet any of the contraindications to the administration of the study drug nintedanib according to the approved SmPC.
Prior treatment with pirfenidone or other treatment for IPF.
Participation in an interventional study.
Patients currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the initiation of therapy with nintedanib.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Greece10 sites

University General Hospital of Evros
Alexandroupoli, 68100
Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med.
Athens, 11527
University General Hospital Attikon
Athens, 124 62
General Hospital of Kerkyra
Corfu, 49100
University Hospital of Heraklion, University Pulmonology Cl
Heraklion, 71100
Univ. Gen. Hosp. of Ioannina
Ioannina, 45 500
General University Hospital of Larissa
Larissa, 41110
Univ. Gen. Hosp. of Patras
Pátrai, 26504
A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki
Thessaloniki, 57010
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, 57010

Other trials in Greece

About this study

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
diagnosed IPF patients initiating treatment with nintedanib

Study groups in NCT03710824
Study group	Role	What they receive
Nintedanib for patients with Idiopathic Pulmonary Fibrosis		Not described Receives: Drug: Nintedanib

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL.
Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction.
Measured: At baseline and at 3 months.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL.
Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction.
Measured: At baseline and at 6 months.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL.
Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction.
Measured: At baseline and at 9 months.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL.
Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction.
Measured: At baseline and at 12 months.

Secondary outcomes (5)

Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score
The modified Medical Research Council (mMRC) consists of a 5-level rating scale (grades 0-4) based on the patient's perception of dyspnoea (perception of breathlessness) in daily activities, with grade 4 representing the most severe category.
Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction.
Measured: At baseline and at 3, 6, 9, and 12 months.
Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS)
Patients were asked at each study visit to rate their perceived intensity of cough due to their IPF on a vertical VAS ranging from 0 to 100, with endpoints labelled as 'no cough' ('100'), 'moderate cough' ('50'), and 'intense cough' ('0').
Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction.
Measured: At baseline, and at 3, 6, 9, and 12 months.
Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ)
SMAQ consisted of 6 items of which, four were dichotomous (Yes/No), one was Likert-type and one was an open question. A patient was considered as non-adherent, if he/she gave a positive response to any of the qualitative questions, and in terms of quantification, if the patient had lost one of the two daily doses for more than 2 days or had not taken medication for more than four complete days during the past 3 months.
Measured: At 3, 6, 9, and 12 months.
Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire
Generalized Anxiety Disorder Screener (GAD-7) is a 7-item instrument validated for anxiety evaluation that could be used in an outpatient setting. Patients were asked at all study visits to indicate how often they experienced anxiety symptoms over the previous two weeks on a 4-point Likert scale as follows: 0 = 'not at all'; 1 = 'several days'; 2 = 'more than half the days'; and 3 = 'nearly every day'.
Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction.
Measured: At baseline, and at 3, 6, 9, and 12 months.
Percentage of Patients That Use Long Term Oxygen Treatment (LTOT)
Percentage of patients that use Long Term Oxygen Treatment (LTOT) is presented.
Measured: At baseline, and at 3, 6, 9, and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 201922 Feb 2023

First posted18 Oct 2018
Study start28 Feb 2019
Primary completion22 Feb 2023
Study completion22 Feb 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: Prospective
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03710824
Sponsor's protocol ID: 1199-0355
Acronym: QUALIFY IPF
Status last verified: Feb 2024
First submitted: 16 Oct 2018
Last updated: 31 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)

All Idiopathic Pulmonary Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib
ClinicalTrials.gov ID: NCT03710824
Acronym / sponsor ID: QUALIFY IPF / 1199-0355
Conditions: Idiopathic Pulmonary Fibrosis
Study type: Observational
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 28 Feb 2019 (actual)
Primary completion: 22 Feb 2023 (actual)
Study completion: 22 Feb 2023 (actual)
First posted: 18 Oct 2018 (actual)
Results: Posted 31 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Nintedanib for patients with Idiopathic Pulmonary Fibrosis	–	Drug: Nintedanib

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Newly diagnosed IPF patients initiating treatment with nintedanib according to their physician's clinical decision will be enrolled in this study. In details, patients will be eligible to enroll in the study if the fulfil all the inclusion criteria.

Key inclusion criteria (5 listed)

Patients ≥40 years of age.
Patients that have signed Informed Consent Form.
Treatment naive patients with an initial IPF diagnosis no more than 3 months prior to enrolment according to 2011 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines who are initiating treatment with nintedanib (as monotherapy for IPF) the latest on the enrollement day or have initiated treatment with nintedanib (as monotherapy for IPF) within the past 7 days prior to enrolment.
Patients for whom the decision to prescribe therapy with nintedanib according to the locally approved product's Summary of Product Characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study.
Patients that are able to read, understand and complete the study specific questionnaires.

Key exclusion criteria (6 listed)

Treatment with nintedanib for more than 7 days prior to study enrolment.
Patients receiving a combination therapy of nintedanib \& pirfenidone for IPF.
Patients that meet any of the contraindications to the administration of the study drug nintedanib according to the approved SmPC.
Prior treatment with pirfenidone or other treatment for IPF.
Participation in an interventional study.

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
Nintedanibdiagnosed IPF patients initiating treatment with nintedanib	Drug	Nintedanib for patients with Idiopathic Pulmonary Fibrosis

Primary outcome

Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months
Time frame: At baseline and at 3 months.
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months
Time frame: At baseline and at 6 months.
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months
Time frame: At baseline and at 9 months.
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction.
Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months
Time frame: At baseline and at 12 months.
St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire assessing 3 domains: symptoms (frequency and severity of respiratory symptoms), activity (activities that cause, or are limited by, breathlessness) and psychosocial impact (range of aspects concerning social functioning and the psychological impact of the disease) that was self-completed by patients at all study visits. The total SGRQ score and the score for each domain range from 0 to 100, with higher scores indicating worse HRQoL. Change from baseline defined as: post baseline - baseline value. Mixed model analysis with fixed effects of visit, GAPBSL stage, FVCBSL (cut off <70%), DLCOBSL (cut off <40%), number of comorbidities and baseline score by visit interaction.

5 secondary outcomes

Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score
Time frame: At baseline and at 3, 6, 9, and 12 months.
Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS)
Time frame: At baseline, and at 3, 6, 9, and 12 months.
Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ)
Time frame: At 3, 6, 9, and 12 months.
Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire
Time frame: At baseline, and at 3, 6, 9, and 12 months.
Percentage of Patients That Use Long Term Oxygen Treatment (LTOT)
Time frame: At baseline, and at 3, 6, 9, and 12 months.

Results and safety

Results posted to the registry on 31 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nintedanib for Patients With Idiopathic Pulmonary Fibrosis	180	149

Primary outcome: Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months

Time frame: At baseline and at 3 months.. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n = 180
total score	2.08 (-2.15 to 6.31)
symptoms domain score	-2.31 (-5.89 to 1.27)
activity domain score	3.37 (-1.15 to 7.89)
psychosocial impact domain score	2.88 (-2.1 to 7.85)

Population analysed: Treated Set (TS): all patients who were enrolled in the trial and have received at least once nintedanib during the trial. Any analysis on primary, secondary and safety endpoints was performed in the TS. The number of participants analysed displays the number of participants with available data at the timepoint of interest, at 3 months.

Primary outcome: Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months

Time frame: At baseline and at 6 months.. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n = 180
total score	3.55 (-0.71 to 7.8)
symptoms domain score	-1.28 (-4.9 to 2.33)
activity domain score	4.18 (-0.37 to 8.73)
psychosocial impact domain score	4.76 (-0.25 to 9.77)

Primary outcome: Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months

Time frame: At baseline and at 9 months.. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n = 180
total score	4.64 (0.36 to 8.92)
symptoms domain score	-1.07 (-4.72 to 2.57)
activity domain score	5.36 (0.78 to 9.94)
psychosocial impact domain score	6.09 (1.05 to 11.13)

Primary outcome: Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months

Time frame: At baseline and at 12 months.. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	Nintedanib for Patients With Idiopathic Pulmonary Fibrosis n = 180
total score	6.00 (1.72 to 10.28)
symptoms domain score	-1.03 (-4.67 to 2.62)
activity domain score	6.19 (1.61 to 10.77)
psychosocial impact domain score	8.17 (3.13 to 13.22)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 52 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nintedanib for Patients With Idiopathic Pulmonary Fibrosis	10 of 180 (5.6%)	12 of 180 (6.7%)	8 of 180

Limitations and caveats (from the sponsor): Study is characterized by inherent limitations attributed to its non-interventional nature. Given that idiopathic pulmonary fibrosis (IPF) diagnosis was done by treating physician, substantial variability in diagnosis may exist. As patient reported outcomes (PROs) were utilized to evaluate, it is important to be aware of potential bias related to such subjective measures. Given the small numbers and heterogeneous population no comparisons / causal associations could be assessed in study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Related trials for Idiopathic Pulmonary Fibrosis

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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.

10 sites 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 10 sites in Greece.

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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Greece. 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 31 Jul 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?

Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months (time frame: At baseline and at 3 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03710824.

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 31 Jul 2024.