Pulmonary FibrosisNCT06912659
The BALANCE Study: A Study in Spain to Find Out Whether a Patient Support Program Helps People With Pulmonary Fibrosis Who Take Nintedanib
An observational study of Pulmonary Fibrosis, run by Boehringer Ingelheim at 1 site in Spain.
Trial summary
The aim of this study is to describe patients' satisfaction with Patient Support Program (Balance Program), Quality of Life and depression symptoms, dosing pattern, disease symptoms, adverse events and nintedanib discontinuation (both permanent and non-permanent) from study inclusion to 12 months of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- How many people
- 166 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jun 2025to 12 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: This study will include patients with IPF and PPF (other than IPF) participating in the PSP Balance Program. The study duration will be from the start of the recruitment period (which will last approximately 6 months) to the last follow-up visit of the last patient (approximately 18 months of total study period). Patients will be followed-up at 6 months and at 12 months.
Who may be able to join
- Adults (≥18 years old at baseline).
- Patients included in the Patient Support Program (PSP) Balance Program.
- Ability to read and speak Spanish correctly according to the investigator criteria.
- Agree to participate and signing informed consent at baseline.
Who cannot join
- Suspicion or diagnosis of any relevant cognitive impairment at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Prospective Study in Patients With Pulmonary Fibrosis Treated With Nintedanib Participating in a Patient Support Program in Spain, to Describe Patient Satisfaction With the Program and to Monitor Quality of Life - BALANCE Study
The aim of this study is to describe patients' satisfaction with Patient Support Program (Balance Program), Quality of Life and depression symptoms, dosing pattern, disease symptoms, adverse events and nintedanib discontinuation (both permanent and non-permanent) from study inclusion to 12 months of follow-up.
- Conditions
- Pulmonary Fibrosis
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients participating in the PSP Balance Program | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with Patient Support Program (PSP) Balance Program at baseline using the Baker Questionnaire.
Baker Questionnaire: This questionnaire contains 18 items divided into four domains. related to general satisfaction, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published.
Items in both modules have a five-option numeric score that ranges from 1 "Not at all" to 5 "Extremely". Total Baker score ranges from 0 to 90, with higher numbers indicating a greater satisfaction. In this study the mean value will be include.
Measured: at Baseline
Secondary outcomes (9)
1. Change in the satisfaction with Patient Support Program (PSP) Balance Program at 6 and 12-month follow-up after inclusion in the study, using the Baker Questionnaire.
Baker Questionnaire: This questionnaire contains 18 items divided into four domains. related to general satisfaction, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published.
Items in both modules have a five-option numeric score that ranges from 1 "Not at all" to 5 "Extremely". Total Baker score ranges from 0 to 90, with higher numbers indicating a greater satisfaction. In this study the mean value will be include.
Measured: up to 12 months
Patient satisfaction with PSP Balance Program at baseline, 6 and 12 months after the inclusion in the study using the Likert scale.
Likert scale: This questionnaire contains 8 items. related to satisfaction with PSP, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published.
Items have a four-option numeric score that ranges from 1 "Not at all" to 4 "Extremely".
Measured: at baseline and up to 12 months
Dosing pattern of nintedanib calculated as absolute number of doses taken correctly divided by all the doses prescribed in that period (6 and 12 months)
Measured: up to 12 months
Time from first dose to permanent discontinuation of nintedanib within 12-month follow-up.
Measured: up to 12 months
Absolute number of nintedanib dose interruptions.
Measured: up to 12 months
Health-Related Quality of Life (HRQoL) at baseline and 12-month follow-up using the L-PF Impacts Questionnaire.
Total score (from 0 to 100 points) and symptoms, impacts, dyspnea, cough and fatigue scores obtained in the L-PF Questionnaire at each visit
L-PF Impacts Questionnaire:
This questionnaire contains 44 items divided into two modules. The Impacts module (21 items) assesses multiple aspects of the quality of life with a recall period of 1 week. The questionnaire was developed recently (before it was used in Idiopathic Pulmonary Fibrosis (IPF) patients only) and there is no cut point published. The Symptoms module yields three domain scores: 1) dyspnea, 2) cough and 3) fatigue as well as a total Symptoms score. Items in both modules (L-PF Impacts and L-PF Symptoms) have a five-option numeric score that ranges from 0 "Not at all" to 4 "Extremely". Total L-PF score ranges from 0 to 100, with higher numbers indicating a greater impairment.
Measured: at baseline and up to 12 months
Anxiety and depression scores in Hospital Anxiety and Depression Scale (HADS) Questionnaire at baseline and 12-month follow-up.
Total score (from 0 to 100 points) obtained in the HADS Questionnaire at each visit.
HADS Questionnaire:
The Hospital Anxiety and Depression Scale-Spanish Version is a 14-item self-report screening scale for anxiety and depression in Spanish-speaking populations. HADS consists of a 7-item anxiety subscale and a 7-item depression subscale. Each item scores on a 4-point Likert scale.
Each item is scored on a scale of 0 = best to 3 = worst, which means that the maximum score for each subscale is 21. To interpret the results, the total sums of each subscale are considered separately. A score of 0 to 7 on any of the subscales is generally considered to be an absence of relevant disorder, 8 to 10 indicates the presence of borderline or borderline symptoms, and a score of 11 or higher suggests a significant presence of anxiety or depression.
Measured: at baseline and up to 12 months
Disease symptoms score in Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire at baseline and 12 months follow-up.
Total score (from 0 to 100 points) obtained in the L-PF Questionnaire at each visit.
L-PF Symptoms Questionnaire:
This questionnaire contains 44 items divided into two modules. The Symptoms module (23 items) rates shortness of breath, cough, and fatigue in the past 24 hours. The questionnaire was developed recently (before it was used in IPF patients only) and there is no cut point published.
Items in both modules (L-PF Impacts and L-PF Symptoms) have a five-option numeric score that ranges from 0 "Not at all" to 4 "Extremely". Total L-PF score ranges from 0 to 100, with higher numbers indicating a greater impairment.
Measured: at baseline and up to 12 months
Absolute number of visits to emergency service and hospitalization related to Interstitial Lung Disease (ILD) between baseline and 12-month follow-up.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start23 Jun 2025
- Primary completion12 Jun 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 166 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
- NCT06912659
- Sponsor's protocol ID
- 1199-0575
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section 'time frame' are fulfilled, researchers can use the 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". Furthermore, researchers can 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Prospective Study in Patients With Pulmonary Fibrosis Treated With Nintedanib Participating in a Patient Support Program in Spain, to Describe Patient Satisfaction With the Program and to Monitor Quality of Life - BALANCE Study
- ClinicalTrials.gov ID
- NCT06912659
- Acronym / sponsor ID
- 1199-0575
- Conditions
- Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to describe patients' satisfaction with Patient Support Program (Balance Program), Quality of Life and depression symptoms, dosing pattern, disease symptoms, adverse events and nintedanib discontinuation (both permanent and non-permanent) from study inclusion to 12 months of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients participating in the PSP Balance Program | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include patients with IPF and PPF (other than IPF) participating in the PSP Balance Program. The study duration will be from the start of the recruitment period (which will last approximately 6 months) to the last follow-up visit of the last patient (approximately 18 months of total study period). Patients will be followed-up at 6 months and at 12 months.
Key inclusion criteria (4 listed)
- Adults (≥18 years old at baseline).
- Patients included in the Patient Support Program (PSP) Balance Program.
- Ability to read and speak Spanish correctly according to the investigator criteria.
- Agree to participate and signing informed consent at baseline.
Key exclusion criteria (1 listed)
- Suspicion or diagnosis of any relevant cognitive impairment at the discretion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient satisfaction with Patient Support Program (PSP) Balance Program at baseline using the Baker Questionnaire.
Time frame: at Baseline
Baker Questionnaire: This questionnaire contains 18 items divided into four domains. related to general satisfaction, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published. Items in both modules have a five-option numeric score that ranges from 1 "Not at all" to 5 "Extremely". Total Baker score ranges from 0 to 90, with higher numbers indicating a greater satisfaction. In this study the mean value will be include.
9 secondary outcomes
1. Change in the satisfaction with Patient Support Program (PSP) Balance Program at 6 and 12-month follow-up after inclusion in the study, using the Baker Questionnaire.
Time frame: up to 12 months
Patient satisfaction with PSP Balance Program at baseline, 6 and 12 months after the inclusion in the study using the Likert scale.
Time frame: at baseline and up to 12 months
Dosing pattern of nintedanib calculated as absolute number of doses taken correctly divided by all the doses prescribed in that period (6 and 12 months)
Time frame: up to 12 months
Time from first dose to permanent discontinuation of nintedanib within 12-month follow-up.
Time frame: up to 12 months
Absolute number of nintedanib dose interruptions.
Time frame: up to 12 months
Health-Related Quality of Life (HRQoL) at baseline and 12-month follow-up using the L-PF Impacts Questionnaire.
Time frame: at baseline and up to 12 months
Anxiety and depression scores in Hospital Anxiety and Depression Scale (HADS) Questionnaire at baseline and 12-month follow-up.
Time frame: at baseline and up to 12 months
Disease symptoms score in Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire at baseline and 12 months follow-up.
Time frame: at baseline and up to 12 months
Absolute number of visits to emergency service and hospitalization related to Interstitial Lung Disease (ILD) between baseline and 12-month follow-up.
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section 'time frame' are fulfilled, researchers can use the 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". Furthermore, researchers can 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.
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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 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 4 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 15 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient satisfaction with Patient Support Program (PSP) Balance Program at baseline using the Baker Questionnaire. (time frame: at Baseline). 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 15 Sep 2026.