Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
- Conditions
- Lung Diseases, Interstitial
- Registration Number
- NCT05503030
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Age =18 years with a confirmed physician diagnosis of connective tissue disease<br> (CTD) associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD)<br><br> - Have been prescribed nintedanib according to the local Summary of Product<br> Characteristics (SmPC) and clinical judgment. Therapy with nintedanib must have been<br> started for clinical reasons independently from the intended patient enrolment into<br> the study at a maximum of 15 days before enrolment into the trial.<br><br>Exclusion Criteria:<br><br> - Patients currently receiving treatment with any investigational<br> drug/device/intervention or who have received any investigational product within 1<br> month or 5 half-lives of the investigational agent (whichever is longer) before the<br> commencement of therapy with nintedanib<br><br> - Patients at baseline with a known condition or reason that will result in withdrawal<br> from the study before the 24-month time point<br><br> - Pregnancy or lactation
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between change from baseline at Month 24 in forced vital capacity (FVC) [percentage (%) predicted] and change from baseline at Month 24 in dyspnoea symptom score [points];Correlation between change from baseline at Month 24 in forced vital capacity (FVC) [% predicted] and change from baseline at Month 24 in cough symptom score [points]
- Secondary Outcome Measures
Name Time Method 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];Correlation between change from baseline at Month 24 in FVC [mL] and change from baseline at Month 24 in cough symptom score [points];Correlation between baseline FVC [% pred] and change in dyspnoea symptom score [points] from baseline at month 24;Correlation between baseline FVC [% pred] and change in cough symptom score [points] from baseline at month 24;Absolute change from baseline in FVC [% pred] at month 24;Absolute change from baseline in FVC [mL] at month 24;Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) dyspnoea symptom score [points] at month 24;Absolute change from baseline in L-PF cough symptom score [points] at month 24;Change in total L-PF score [points] from baseline at month 24, or the end of the observation