Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Registration Number
- NCT02802345
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nintedanib + placebo matching sildenafil Placebo - Nintedanib + Sildenafil Nintedanib - Nintedanib + placebo matching sildenafil Nintedanib - Nintedanib + Sildenafil Sildenafil -
- Primary Outcome Measures
Name Time Method Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score at Week 12 Baseline and week 12 The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. Scores range from 0 to 100, with higher scores indicating more limitations. The mean and standard error presented are actually adjusted mean for change from baseline and its standard error.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Dyspnoea Using UCSD SOBQ at Week 24 Baseline and week 24 The UCSD SOBQ is a 24-item questionnaire developed to to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.
Change From Baseline in Dyspnoea Using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at Week 12 Baseline and week 12 The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.
Percentage of Patients With On-treatment Serious Adverse Events (SAE) From Baseline to Week 24 Baseline and week 24 Percentage of patients with on-treatment serious adverse events (SAE) from baseline to Week 24 is presented.
Change From Baseline in SGRQ Total Score at Week 24 Baseline and week 24 The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.
Trial Locations
- Locations (85)
Royal Prince Alfred Hospital
🇦🇺Camperdown, Sydney, New South Wales, Australia
HOP Bichat
🇫🇷Paris, France
Care Institute Of Medical Sciences
🇮🇳Ahmedabad, India
Jehangir Clinical Development Centre Pvt. Ltd.
🇮🇳Pune, India
Kurume University Hospital
🇯🇵Fukuoka, Kurume, Japan
Ibarakihigashi National Hospial
🇯🇵Ibaraki, Naka-gun, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
🇯🇵Osaka, Sakai, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
Toho University Omori Medical Center
🇯🇵Tokyo, Ota-ku, Japan
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Quirónsalud Madrid
🇪🇸Pozuelo de Alarcón, Spain
Hospital ClÃnico San Carlos
🇪🇸Madrid, Spain
Hospital Universitari de Girona Doctor Josep Trueta
🇪🇸Girona, Spain
Southmead Hospital
🇬🇧Bristol, United Kingdom
Ninewells Hospital & Medical School
🇬🇧Dundee, Scotland, United Kingdom
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Papworth Hospital
🇬🇧Cambridge, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
South Tyneside District Hospital
🇬🇧Tyne And Wear, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
UZ Leuven
🇧🇪Leuven, Belgium
University of Florida College of Medicine
🇺🇸Jacksonville, Florida, United States
Michigan Clinical Research Unit
🇺🇸Ann Arbor, Michigan, United States
Lowcountry Lung and Crit Care
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
🇧🇪Antwerpen, Belgium
ULB Hopital Erasme
🇧🇪Bruxelles, Belgium
University of Alberta Hospital (University of Alberta)
🇨🇦Edmonton, Alberta, Canada
QEII Health Sciences Centre (Dalhousie University)
🇨🇦Halifax, Nova Scotia, Canada
HOP Louis Pradel
🇫🇷Bron cedex, France
HOP Calmette
🇫🇷Lille, France
HOP Nord
🇫🇷Marseille, France
HOP Arnaud de Villeneuve
🇫🇷Montpellier, France
HOP Pasteur
🇫🇷Nice, France
HOP Européen G. Pompidou
🇫🇷Paris, France
Universitätsmedizin Greifswald
🇩🇪Greifswald, Germany
Lungenfachklinik Immenhausen
🇩🇪Immenhausen, Germany
Fachkrankenhaus Coswig GmbH
🇩🇪Coswig, Germany
HOP Pontchaillou
🇫🇷Rennes, France
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
🇩🇪Essen, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg im Breisgau, Germany
Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Gießen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Wissenschaftliches Institut Bethanien
🇩🇪Solingen, Germany
Sanjivani Superspeciality Hospital Pvt. Ltd.
🇮🇳Ahmedabad, India
Sri Bala Medical Centre & Hospitals
🇮🇳Coimbatore, India
Fortis Hospital
🇮🇳Kolkata, India
Osp. Clin. SS. Anunziata
🇮🇹Chieti Scalo, Italy
Ospedale Colonnello D Avanzo
🇮🇹Foggia, Italy
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
🇮🇹FORLì, Italy
Osp. S. Giuseppe Fatebenefratelli
🇮🇹Milano, Italy
Università di Modena e Reggio Emilia
🇮🇹Modena, Italy
Az. Ospedaliera Universitaria Polic.Tor Vergata
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria di Padova
🇮🇹Padova, Italy
Policlinico Gemelli
🇮🇹Roma, Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
🇮🇹Siena, Italy
Ospedale Riuniti di Ancona
🇮🇹Torrette Di Ancona (Ancona), Italy
Tosei General Hospital
🇯🇵Aichi, Seto, Japan
Ogaki Municipal Hospital
🇯🇵Gifu, Ogaki, Japan
Nuevo Hospital Civil de Guadalajara DR. JUAN I. MENCHACA
🇲🇽Guadalajara, Mexico
Instituto Nacional de Enfermedades Respiratorias Ismael CosÃo Villegas
🇲🇽Mexico, Mexico
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
National Hospital Organization Himeji Medical Center
🇯🇵Hyogo, Himeji, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Kanagawa, Yokohama, Japan
Centro de Prevención y Rehabilitación de Enfermedades Pulmon
🇲🇽Monterrey, Mexico
Centro Respiratorio de Mexico
🇲🇽México, Mexico
The Lung Research Center, LLC
🇺🇸Chesterfield, Missouri, United States
Pulmonary Assoc of Stamford
🇺🇸Stamford, Connecticut, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Minnesota Lung Center
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Clinical Research Solutions
🇺🇸Dayton, Ohio, United States
Mercy Respiratory Specialist
🇺🇸Toledo, Ohio, United States
NewYork-Presbyterian/Weill Cornell Medical Center
🇺🇸New York, New York, United States
Pulmonary Associates of Richmond, Inc.
🇺🇸Richmond, Virginia, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada