An observational study in Pulmonary Fibrosis, sponsored by Boehringer Ingelheim. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Boehringer Ingelheim · Observational
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.
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's enrollment of 166 is above the median of 130 across 229 observational studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion criteria
- Suspicion or diagnosis of any relevant cognitive impairment at the discretion of the investigator.
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.
Time frame: at Baseline
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.
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.
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".
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.
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.
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.
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.
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.
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.
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
Plan to share: 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.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim