To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
274
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score at Week 12
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. Scores range from 0 to 100, with higher scores indicating more limitations. The mean and standard error presented are actually adjusted mean for change from baseline and its standard error.
Time frame: Baseline and week 12
Change From Baseline in Dyspnoea Using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at Week 12
The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.
Time frame: Baseline and week 12
Change From Baseline in SGRQ Total Score at Week 24
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.
Time frame: Baseline and week 24
Change From Baseline in Dyspnoea Using UCSD SOBQ at Week 24
The UCSD SOBQ is a 24-item questionnaire developed to to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Pulmonary Assoc of Stamford
Stamford, Connecticut, United States
University of Florida College of Medicine
Jacksonville, Florida, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Michigan Clinical Research Unit
Ann Arbor, Michigan, United States
Minnesota Lung Center
Minneapolis, Minnesota, United States
The Lung Research Center, LLC
Chesterfield, Missouri, United States
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 75 more locations
Time frame: Baseline and week 24
Percentage of Patients With On-treatment Serious Adverse Events (SAE) From Baseline to Week 24
Percentage of patients with on-treatment serious adverse events (SAE) from baseline to Week 24 is presented.
Time frame: Baseline and week 24