This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg bis in die (BID twice daily) on the progression of IPF measured by using High Resolution Computerized Tomography(HRCT), lung function, functional component (6MWT), biomarkers, and PRO component (PROs) with continued treatment and assessments for up to 18 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
113
twice daily dosing
gelating capsule
Western CT Medical Group, P.C.
Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months
Relative change from baseline in HRCT QLF score at 6 months was calculated as the difference of the QLF score at month 6 minus the QLF score at baseline divided by the baseline QLF score. The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline.
Time frame: Baseline and 6 Months
Effect of Six Month Delayed Treatment Onset: Relative Change From Baseline in HRCT QLF Score at 12 Months
Relative change from baseline in HRCT QLF score at 12 months was calculated as the ratio of the QLF score at 12 months to baseline. Greater values of the QLF score represented a worse health status and hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline. Note that due to the change in study design, patients randomized to the placebo group were treated with nintedanib after completion of the first 6-month treatment period. Therefore, this new endpoint was defined to address the effect of a 6-month delayed onset of nintedanib treatment.
Time frame: Baseline and 12 Months
Absolute Change in Forced Vital Capacity (FVC) From Baseline at 6 Months
Absolute change in Forced Vital Capacity (FVC) from baseline at 6 months is presented.
Time frame: Baseline and 6 Months
Relative Change in FVC From Baseline at 6 Months
Relative change in FVC from baseline at 6 months is presented.
Time frame: Baseline and 6 Months
Categorical Change in FVC From Baseline at 6 Months
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Danbury, Connecticut, United States
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Sarasota, Florida, United States
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Skokie, Illinois, United States
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Lexington, Kentucky, United States
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Minneapolis, Minnesota, United States
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Lebanon, New Hampshire, United States
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Mineola, New York, United States
ID Clinical Research, LTD
Toledo, Ohio, United States
The Oregon Clinic
Portland, Oregon, United States
Lowcountry Lung and Crit Care
Charleston, South Carolina, United States
...and 15 more locations
Percentage of participants reporting categorical change in FVC from baseline at 6 months are presented.
Time frame: Baseline and 6 Months
St. George's Respiratory Questionnaire (SGRQ) Total Score Change From Baseline at 6 Months
SGRQ total score change from baseline at 6 months is presented. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6).
Time frame: Baseline and 6 Months
6MWT Total Distance Walked Change From Baseline at 6 Months
Change in total distance covered in 6-minute walk test (6MWT) from baseline at 6 month is presented. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria.
Time frame: Baseline and 6 Months
University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Change From Baseline at 6 Months
University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) change from baseline at 6 months is presented. Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6).
Time frame: Baseline and 6 Months
All-cause Mortality at 6 Months
Percentage of subjects died from all causes between 0 to 6 months are presented.
Time frame: 6 Months
Respiratory Hospitalizations at 6 Months
Percentage of subjects hospitalized due to respiratory problems between 0 to 6 months are presented.
Time frame: 6 Months
Respiratory Mortality at 6 Months
Percentage of subjects who died due to respiratory cause between 0 to 6 months are presented.
Time frame: 6 Months
Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbations at 6 Months
Percentage of subjects experienced first acute IPF exacerbations (based on Investigator reported adverse events) between 0 to 6 months are presented.
Time frame: 6 Months