Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
- Registration Number
- NCT01170065
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.
The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).
As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BIBF 1120 medium bid BIBF 1120 Intermediate dose BIBF 1120 twice daily BIBF 1120 low qd BIBF 1120 Low dose BIBF 1120 once daily BIBF 1120 low bid BIBF 1120 Low dose BIBF 1120 twice daily BIBF 1120 high bid BIBF 1120 High dose BIBF 1120 twice daily
- Primary Outcome Measures
Name Time Method Annual Rate of Decline in Forced Vital Capacity (FVC) From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months 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 Outcome Measures
Name Time Method Overall Survival From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months Overall survival is defined as the time from the first intake of nintedanib in trial 1199.35 to death.
For presentation of overall survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment survival is calculated within each treatment arm.Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months Percentage of patients with at least one acute idiopathic pulmonary fibrosis (IPF) exacerbation are presented.
An exacerbation was defined as otherwise unexplained clinical features occurring within
1 month including all of the following:
* Progression of dyspnoea over several days to 4 weeks
* New diffuse pulmonary infiltrates on chest X-ray and/or high-resolution computerised tomography (HRCT) Parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit
* A decrease in arterial oxygen partial pressure (PaO2) of ≥10 mmHg or PaO2/fraction of inspired oxygen (FiO2) of \<225 mmHg since the last visit
* Exclusion of infection based on routine clinical practice and microbiological studies
* Absence of other contributory causes such as congestive heart failure, pulmonary embolism, etc.Progression-Free Survival From first trial drug intake in 1199.35 to disease progression; up to 61.8 months Progression-free survival was defined as the time from the first nintedanib intake in trial 1199.35 to disease progression.
For presentation of progression-free survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment progression-free survival is calculated within each treatment arm.Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months Haemoglobin corrected DLCO decrease was a secondary endpoint for the trial. It was considered important that all investigators used the same method of testing and recording data at each visit for each patient.
Haemoglobin corrected DLCO was calculated for each patient using the following formulae:
Males: Hb corrected DLCO = measured DLCO x (10.22 + Hb concentration) / (1.7 x Hb concentration) Females: Hb corrected DLCO = measured DLCO x (9.38 + Hb concentration) / (1.7 x Hb concentration). Annual rate of decline in haemoglobin corrected diffusing capacity of the lung for carbon monoxide (DLCO) decrease is presented.Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days Percentage of patients with at least one Adverse events (AEs), with investigator defined drug-related AEs, AEs leading to discontinuation of trial drug, serious AEs are presented
Incidence of Patients With at Least One Acute IPF Exacerbation Over Time From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months Incidence rate = (Patients with at least one acute IPF exacerbation / Total number of years at risk) x 100
Time to First Acute IPF Exacerbation From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months Due to rare events, the median of time to event is not calculable, thus Kaplan-Meier estimates (providing the percentage of patients without acute IPF exacerbation for a certain amount of time after treatment) and confidence intervals (using Greenwood variance formula) are reported and presented within each treatment arm as secondary endpoint.
Trial Locations
- Locations (57)
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Instituto Nacional del Tórax
🇨🇱Santiago, Chile
Special. Hospital for Active Treatment, Sv. Sofia 2nd Clinic
🇧🇬Sofia, Bulgaria
Respiratory Clinical Trial Pty Ltd.
🇦🇺Glen Osmond, South Australia, Australia
INSARES
🇦🇷Mendoza, Argentina
Royal Perth Hospital-Lung Transplant Unit
🇦🇺Perth, Western Australia, Australia
ULB Hopital Erasme
🇧🇪Bruxelles, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
University Hospital Na Bulovce, Prague
🇨🇿Prague 8, Czechia
Irmandade Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Peking Union Medical College Hospital
🇨🇳Beijing, China
Klinik Donaustauf
🇩🇪Donaustauf, Germany
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
🇲🇽Distrito Federal, Mexico
The Medicines Evaluation Unit
🇬🇧Manchester, United Kingdom
Ospedale di Cattinara
🇮🇹Trieste, Italy
Yvoir - UNIV UCL de Mont-Godinne
🇧🇪Yvoir, Belgium
Beijing Chao-Yang Hospital
🇨🇳Beijing, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, China
HOP Avicenne
🇫🇷Bobigny, France
Masaryk Hospital, Usti nad Labem
🇨🇿Usti nad Labem, Czechia
HOP Dijon, Pneumo, Dijon
🇫🇷DIJON Cedex, France
HOP Calmette
🇫🇷Lille, France
HOP Pasteur
🇫🇷Nice Cedex 1, France
HOP Arnaud de Villeneuve
🇫🇷Montpellier, France
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
🇩🇪Großhansdorf, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg/Breisgau, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
🇩🇪Essen, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Klinikum der Universität München - Campus Großhadern
🇩🇪München, Germany
Csongrad County's Hosp.
🇭🇺Deszk, Hungary
University Hospital of Heraklion, University Pulmonology Cl
🇬🇷Heraklion, Greece
University General Hospital of Evros
🇬🇷Alexandroupolis, Greece
University of Pecs, 1st internal Med. Dept., Pulmonology
🇭🇺Pecs, Hungary
Università di Modena e Reggio Emilia
🇮🇹Modena, Italy
Osp. S. Giuseppe Fatebenefratelli
🇮🇹Milano, Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
🇮🇹Siena, Italy
Ospedale C. G. Mazzoni
🇮🇹Ascoli Piceno, Italy
Università Federico II
🇮🇹Napoli, Italy
Pol. Universitario Tor Vergata
🇮🇹Roma, Italy
Università di Perugia
🇮🇹Terni, Italy
St. Antonius ziekenhuis, locatie Nieuwegein
🇳🇱Nieuwegein, Netherlands
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
🇵🇹Coimbra, Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
🇵🇹Lisboa, Portugal
Centro Hospitalar São João,EPE
🇵🇹Porto, Portugal
CHLN, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Central Scientific Research Insitute of Tuberculosis
🇷🇺Moscow, Russian Federation
Scientific Research Institute of Pulmonology
🇷🇺St. Petersburg, Russian Federation
Hospital Dr. Peset
🇪🇸Valencia, Spain
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Southmead Hospital
🇬🇧Westbury On Trym, United Kingdom
The Queen Elizabeth Hospital
🇦🇺Woodville, South Australia, Australia
QEII Health Sciences Centre (Dalhousie University)
🇨🇦Halifax, Nova Scotia, Canada
HOP Bichat
🇫🇷Paris Cedex 18, France
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China