A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen Months
Overview
- Phase
- Phase 3
- Intervention
- Nintedanib
- Conditions
- Idiopathic Pulmonary Fibrosis
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 113
- Locations
- 25
- Primary Endpoint
- Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Nintedanib
150 mg twice daily
Intervention: Nintedanib
Placebo
twice daily dosing
Intervention: Matching Placebo
Outcomes
Primary Outcomes
Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months
Time Frame: 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 Outcomes
- Effect of Six Month Delayed Treatment Onset: Relative Change From Baseline in HRCT QLF Score at 12 Months(Baseline and 12 Months)
- St. George's Respiratory Questionnaire (SGRQ) Total Score Change From Baseline at 6 Months(Baseline and 6 Months)
- Absolute Change in Forced Vital Capacity (FVC) From Baseline at 6 Months(Baseline and 6 Months)
- 6MWT Total Distance Walked Change From Baseline at 6 Months(Baseline and 6 Months)
- Relative Change in FVC From Baseline at 6 Months(Baseline and 6 Months)
- Categorical Change in FVC From Baseline at 6 Months(Baseline and 6 Months)
- Respiratory Hospitalizations at 6 Months(6 Months)
- Respiratory Mortality at 6 Months(6 Months)
- University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Change From Baseline at 6 Months(Baseline and 6 Months)
- All-cause Mortality at 6 Months(6 Months)
- Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbations at 6 Months(6 Months)