Idiopathic Pulmonary Fibrosis
Conditions
Brief 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.
Interventions
DRUGNintedanib
diagnosed IPF patients initiating treatment with nintedanib
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score | At baseline and at 3, 6, 9, and 12 months. | 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. |
| Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) | At baseline, and at 3, 6, 9, and 12 months. | Percentage of patients that use Long Term Oxygen Treatment (LTOT) is presented. |
| Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS) | At baseline, and at 3, 6, 9, and 12 months. | 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. |
| Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ) | At 3, 6, 9, and 12 months. | 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. |
| Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire | At baseline, and at 3, 6, 9, and 12 months. | 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. |
Countries
Greece
Participant flow
Recruitment details
This observational study aimed to collect data on various patient reported outcomes (PROs) in patients with idiopathic pulmonary fibrosis (IPF) under treatment with nintedanib (QUALIFY Idiopathic Pulmonary Fibrosis) over a 52-week period in Greece. Data of 180 newly diagnosed IPF patients enrolled from 10 University Pulmonology Clinics and Reference Centers of the Public Hospital Setting were collected.
Pre-assignment details
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Treatment interruption and dose reduction were allowed as medically indicated. Rescue medication was allowed for all subjects as required.
Participants by arm
| Arm | Count |
|---|---|
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis Patients were considered eligible if they were ≥40 years old y/o, had signed informed consent form, were treatment-naïve with an initial IPF diagnosis no more than 3 months prior to enrolment and were initiating treatment with nintedanib (as monotherapy) the latest on the enrolment day or had initiated it within the past 7 days prior to enrolment, and for whom the decision to prescribe treatment with nintedanib was according to the locally approved treatment label. | 180 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 25 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Treatment discontinuation | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Nintedanib for Patients With Idiopathic Pulmonary Fibrosis |
|---|---|
| Age, Continuous | 72.96 Years STANDARD_DEVIATION 7.829 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 180 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 136 Participants |
| St. George's Respiratory Questionnaire (SGRQ) scores at baseline activity domain score | 48.19 Score on a scale STANDARD_DEVIATION 22.956 |
| St. George's Respiratory Questionnaire (SGRQ) scores at baseline psychosocial impact score | 24.01 Score on a scale STANDARD_DEVIATION 20.487 |
| St. George's Respiratory Questionnaire (SGRQ) scores at baseline SGRQ total score | 32.93 Score on a scale STANDARD_DEVIATION 19.319 |
| St. George's Respiratory Questionnaire (SGRQ) scores at baseline symptom domain score | 32.09 Score on a scale STANDARD_DEVIATION 21.089 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 180 |
| other Total, other adverse events | 12 / 180 |
| serious Total, serious adverse events | 10 / 180 |
Outcome results
Primary
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.
Time frame: At baseline and at 12 months.
Population: 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 12 months.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months | total score | 6.00 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months | symptoms domain score | -1.03 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months | activity domain score | 6.19 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 12 Months | psychosocial impact domain score | 8.17 Score on a scale |
Primary
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.
Time frame: At baseline and at 3 months.
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months | total score | 2.08 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months | symptoms domain score | -2.31 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months | activity domain score | 3.37 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 3 Months | psychosocial impact domain score | 2.88 Score on a scale |
Primary
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.
Time frame: At baseline and at 6 months.
Population: 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 6 months.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months | total score | 3.55 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months | symptoms domain score | -1.28 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months | activity domain score | 4.18 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 6 Months | psychosocial impact domain score | 4.76 Score on a scale |
Primary
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.
Time frame: At baseline and at 9 months.
Population: 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 9 months.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months | total score | 4.64 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months | symptoms domain score | -1.07 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months | activity domain score | 5.36 Score on a scale |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline in Health Related Quality of Life (HRQoL) Using SGRQ Score at 9 Months | psychosocial impact domain score | 6.09 Score on a scale |
Secondary
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.
Time frame: At baseline, and at 3, 6, 9, and 12 months.
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS) | At 3 months | -0.72 Score on a scale. |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS) | At 6 months | -3.73 Score on a scale. |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS) | At 9 months | -2.13 Score on a scale. |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change Form Baseline to the Follow up Period of Cough Burden With Cough-Visual Analogue Scale (Cough-VAS) | At 12 months | -1.25 Score on a scale. |
Secondary
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.
Time frame: At baseline and at 3, 6, 9, and 12 months.
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score | At 3 months | 0.30 Score on a scale. |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score | At 6 months | 0.31 Score on a scale. |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score | At 9 months | 0.40 Score on a scale. |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change From Baseline of Dyspnoea Burden With Modified Medical Research Council Scale (mMRC) Score | At 12 months | 0.39 Score on a scale. |
Secondary
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.
Time frame: At baseline, and at 3, 6, 9, and 12 months.
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire | At 3 months | 0.09 Score on a scale. |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire | At 6 months | 0.48 Score on a scale. |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire | At 9 months | 0.77 Score on a scale. |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Mean Change of Anxiety in IPF Patients Treated With Nintedanib From Baseline to Follow up Period Via Generalized Anxiety Disorder Screener (GAD-7) Questionnaire | At 12 months | 0.97 Score on a scale. |
Secondary
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.
Time frame: At 3, 6, 9, and 12 months.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ) | At 3 months | 70.75 Percentage of participants |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ) | At 6 months | 74.13 Percentage of participants |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ) | At 9 months | 75.18 Percentage of participants |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Percentage of Adhered Patients to Nintedanib Treatment With Simplified Medication Adherence Questionnaire (SMAQ) | At 12 months | 76.81 Percentage of participants |
Secondary
Percentage of Patients That Use Long Term Oxygen Treatment (LTOT)
Percentage of patients that use Long Term Oxygen Treatment (LTOT) is presented.
Time frame: At baseline, and at 3, 6, 9, and 12 months.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) | At baseline | 17.78 Percentage of participants |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) | At 3 months | 16.97 Percentage of participants |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) | At 6 months | 16.34 Percentage of participants |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) | At 9 months | 15.33 Percentage of participants |
| Nintedanib for Patients With Idiopathic Pulmonary Fibrosis | Percentage of Patients That Use Long Term Oxygen Treatment (LTOT) | At 12 months | 15.44 Percentage of participants |