Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Drug: Matching Placebo
- Registration Number
- NCT01979952
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Matching Placebo twice daily dosing Nintedanib Nintedanib 150 mg twice daily
- Primary Outcome Measures
Name Time Method Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months Baseline and 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.
- Secondary Outcome Measures
Name Time Method Effect of Six Month Delayed Treatment Onset: Relative Change From Baseline in HRCT QLF Score at 12 Months Baseline and 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.St. George's Respiratory Questionnaire (SGRQ) Total Score Change From Baseline at 6 Months Baseline and 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).Absolute Change in Forced Vital Capacity (FVC) From Baseline at 6 Months Baseline and 6 Months Absolute change in Forced Vital Capacity (FVC) from baseline at 6 months is presented.
Relative Change in FVC From Baseline at 6 Months Baseline and 6 Months Relative change in FVC from baseline at 6 months is presented.
6MWT Total Distance Walked Change From Baseline at 6 Months Baseline and 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.Categorical Change in FVC From Baseline at 6 Months Baseline and 6 Months Percentage of participants reporting categorical change in FVC from baseline at 6 months are presented.
Respiratory Hospitalizations at 6 Months 6 Months Percentage of subjects hospitalized due to respiratory problems between 0 to 6 months are presented.
Respiratory Mortality at 6 Months 6 Months Percentage of subjects who died due to respiratory cause between 0 to 6 months are presented.
University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Change From Baseline at 6 Months Baseline and 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).All-cause Mortality at 6 Months 6 Months Percentage of subjects died from all causes between 0 to 6 months are presented.
Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbations at 6 Months 6 Months Percentage of subjects experienced first acute IPF exacerbations (based on Investigator reported adverse events) between 0 to 6 months are presented.
Trial Locations
- Locations (25)
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
QEII Health Sciences Centre (Dalhousie University)
🇨🇦Halifax, Nova Scotia, Canada
Lowcountry Lung and Crit Care
🇺🇸Charleston, South Carolina, United States
University of Alberta Hospital (University of Alberta)
🇨🇦Edmonton, Alberta, Canada
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Minnesota Lung Research
🇺🇸Minneapolis, Minnesota, United States
Annette C & Harold C Simmons Transplant Institute
🇺🇸Dallas, Texas, United States
CHUS Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
Western CT Medical Group, P.C.
🇺🇸Danbury, Connecticut, United States
Chest Medicine Clinical Services
🇺🇸Skokie, Illinois, United States
Clinical Research Center Sarasota Memorial Hosptial
🇺🇸Sarasota, Florida, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
ID Clinical Research, LTD
🇺🇸Toledo, Ohio, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Ankara Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi
🇹🇷Istanbul, Turkey
Cukurova Universitesi Tip Fakultesi Gog. Hast. Anabilim Dali
🇹🇷Adana, Turkey
Ege Universitesi T.F.
🇹🇷Izmir, Turkey
Sureyyapasa Gogus Hast. ve Gogus Cer. Egit. ve Aras. Has.
🇹🇷Istanbul, Turkey
Yedikule Gog. Hst. EAH
🇹🇷Istanbul, Turkey
Dr.Suat Seren EAH
🇹🇷Izmir, Turkey
Concordia Hospital
🇨🇦Winnipeg, Manitoba, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada