A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Overview
- Phase
- Phase 3
- Intervention
- BIBF 1120
- Conditions
- Pulmonary Fibrosis
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 515
- Locations
- 98
- Primary Endpoint
- Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.
In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.
Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.
Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BIBF 1120
patient receives capsules containing BIBF 1120 twice a day
Intervention: BIBF 1120
placebo
patient receives capsules identical to those containing active drug
Intervention: placebo
Outcomes
Primary Outcomes
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
Time Frame: 52 weeks
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate
Secondary Outcomes
- Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks(Baseline and 52 weeks)
- Time to Death Over 52 Weeks(52 weeks)
- Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)(52 weeks)
- Time to On-treatment Death(52 weeks)
- Time to Death or Lung Transplant Over 52 Weeks(52 weeks)
- Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.(52 weeks)
- Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks(Baseline and 52 weeks)
- Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks(Baseline and 52 weeks)
- Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold(Baseline and 52 weeks)
- Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)(Baseline and 52 weeks)
- Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)(baseline and 52 weeks)
- Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)(Baseline and 52 weeks)
- Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)(baseline and 52 weeks)
- Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)(Baseline and 52 weeks)
- Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)(Baseline and 52 weeks)
- Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs)(Baseline and 52 weeks)
- Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks(baseline and 52 weeks)
- Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks(Baseline and 52 weeks)
- Proportion of FVC Responders Using 5% Threshold at 52 Weeks(52 weeks)
- Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)(52 weeks)
- Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)(baseline, 12 weeks, 24 weeks and 52 weeks)
- Risk of an Acute IPF Exacerbation Over 52 Weeks(52 weeks)
- Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation(52 weeks)
- Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks(Baseline and 52 weeks)
- Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks(Baseline and 52 weeks)
- Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold(Baseline and 52 weeks)
- FVC Responders Using 10% Threshold at 52 Weeks(52 weeks)
- Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)(Baseline and 52 weeks)