Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
Study Details
Study Description
Brief Summary
The aim of this study is to identify correlations between changes from the baseline at Month 24 in Forced Vital Capacity (FVC) (% predicted and mL) and changes from the baseline at Month 24 in cough or dyspnoea scores [points] as measured in the living with pulmonary fibrosis questionnaire (L-PF) over 24 months of nintedanib treatment in patients with connective tissues disease-associated progressive fibrosing interstitial lung disease (CTD associated PF-ILD) under routine clinical practice conditions in Greece.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Nintedanib for CTD-associated PF-ILD patients in Greece Connective Tissue Disease (CTD)-associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
Drug: Nintedanib
Nintedanib
|
Outcome Measures
Primary Outcome Measures
- Correlation between changes from baseline at Month 24 in forced vital capacity (FVC) [percentage (%) predicted] and changes from baseline at Month 24 in dyspnoea symptom score [points] [At baseline and at month 24]
- Correlation between changes from baseline at Month 24 in forced vital capacity (FVC) [% predicted] and changes from baseline at Month 24 in cough symptom score [points] [At baseline and at month 24]
Secondary Outcome Measures
- Correlation between the change from baseline at Month 24 in forced vital capacity (FVC) [milliLitres (mL)] and change from baseline at Month 24 in dyspnoea symptom score [points] [At baseline and at month 24]
- Correlation between change from baseline at Month 24 in FVC [mL] and change from baseline at Month 24 in cough symptom score [At baseline and at month 24]
- Correlation between baseline FVC [% pred] and change in dyspnoea symptom score from baseline at month 24 [At baseline and at month 24]
- Correlation between baseline FVC [% pred] and change in cough symptom score from baseline at month 24 [At baseline and at month 24]
- Absolute change from baseline in FVC [% pred] at month 24 [At baseline and at month 24]
- Absolute change from baseline in FVC [mL] at month 24 [At baseline and at month 24]
- Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) dyspnoea symptom score at month 24 [At baseline and at month 24]
- Absolute change from baseline in L-PF cough symptom score at month 24 [At baseline and at month 24]
- Change in total L-PF score from baseline at month 24, or the end of the observation [At baseline and up to 24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years with a confirmed physician diagnosis of connective tissue disease (CTD) associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
-
Have been prescribed nintedanib according to the local Summary of Product Characteristics (SmPC) and clinical judgment. Therapy with nintedanib must have been started for clinical reasons independently from the intended patient enrolment into the study at a maximum of 15 days before enrolment into the trial.
Exclusion Criteria:
-
Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nintedanib
-
Patients at baseline with a known condition or reason that will result in withdrawal from the study before the 24-month time point
-
Pregnancy or lactation
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1199-0501