Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension
NCT ID: NCT02951429
Last Updated: 2020-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
177 participants
INTERVENTIONAL
2016-12-31
2020-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pirfenidone + Placebo
Participants will receive pirfenidone along with placebo matched to sildenafil, orally, three times a day (TID) for 52 weeks.
Pirfenidone
Pirfenidone will be given in the range of 1602 to 2403 milligram per day (mg/day), as 3 divided doses.
Placebo
Placebo matched with sildenafil.
Pirfenidone + Sildenafil
Participants will receive pirfenidone along with sildenafil, orally, TID for 52 weeks.
Pirfenidone
Pirfenidone will be given in the range of 1602 to 2403 milligram per day (mg/day), as 3 divided doses.
Sildenafil
Sildenafil will be given as 20 mg, TID.
Interventions
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Pirfenidone
Pirfenidone will be given in the range of 1602 to 2403 milligram per day (mg/day), as 3 divided doses.
Placebo
Placebo matched with sildenafil.
Sildenafil
Sildenafil will be given as 20 mg, TID.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmation of IPF diagnosis by the investigator in accordance with the 2011 international consensus guidelines at screening
* Advanced IPF (defined as a measurable carbon monoxide diffusing capacity \[DLCO\] less than or equal to (\<=)40% of predicted value at Screening) and intermediate or high probability of group 3 pulmonary hypertension (PH)
* Participants receiving pirfenidone for at least 12 weeks, at a dose in the range of 1602 to 2403 mg/day for at least 4 weeks prior to Screening and must not have experienced either a new or ongoing adverse event of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (version 4.03) Grade 2 or higher and considered by the investigator to be related to pirfenidone, or an interruption of pirfenidone treatment of greater than (\>)7 days for any reason
* WHO Functional Class II or III at Screening
* 6MWD of 100 to 450 meters at screening
* Women of childbearing potential and for men who are not surgically sterile agreement to remain abstinent or use of contraceptive measures
Exclusion Criteria
* History of clinically significant cardiac disease
* History of coexistent and clinically significant COPD, bronchiectasis, asthma, inadequately treated sleep-disordered breathing, or any clinically significant pulmonary diseases or disorders other than IPF or PH secondary to IPF
* History of use of drugs and toxins known to cause PAH, including aminorex, fenfluramine, dexenfluramine, and amphetamines
* FEV1/FVC ratio less than (\<) 0.70 post bronchodilator; SpO2 saturation at rest \<92% with \>= 6 liters (L) of supplemental oxygen at Screening
* Extent of emphysema greater than the extent of fibrotic changes (honeycombing and reticular changes) on any previous high-resolution computed tomography (HRCT) scan, in the opinion of the Investigator
* Smoked tobacco within 3 months prior to screening or is unwilling to avoid tobacco products (cigarettes, pipe, cigars) throughout the study
* Illicit drug or significant alcohol abuse
* Electrocardiogram (ECG) with a heart-rate corrected QT interval (corrected using Fridericia's formula \[QTcF\]) \>=500 milliseconds (ms) at screening, or a family or personal history of long QT syndrome
40 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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ULB Hôpital Erasme
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
CHU Sart-Tilman
Liège, , Belgium
CHU UCL Mont-Godinne
Mont-godinne, , Belgium
Hotel Dieu Hospital
Kingston, Ontario, Canada
CHUM Hôpital Notre-Dame
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
Ste. Foy, Quebec, Canada
Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN
Praha 4 - Krc, , Czechia
Clinical Research Center (CRC), Faculty of Medicine, Alexandria University
Alexandria, , Egypt
Kasr El-Aini-Chest Unit; Department 3-Chest Unit
Cairo, , Egypt
Ain Shams University Hospital-Chest unit; Chest unit
Cairo, , Egypt
Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie
Coswig, , Germany
Klinik Donaustauf Zentrum für Pneumologie
Donaustauf, , Germany
Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
Essen, , Germany
Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda
Fulda, , Germany
Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
Giessen, , Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, , Germany
Fachklinik für Lungenerkrankungen
Immenhausen, , Germany
Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
München, , Germany
Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology
Athens, , Greece
University General Hospital of Athens "Attikon", B' University Pulmonary Clinic
Chaïdári, , Greece
University General Hospital of Heraklio, Pulmonary Clinic
Heraklio, , Greece
Semmelweis Egyetem X; Pulmonologiai Klinika
Budapest, , Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, , Hungary
Soroka; Pulmonary Clinic
Beersheba, , Israel
Carmel Medical Center; Pulmonary Institute
Haifa, , Israel
Shaare Zedek Medical Center; Pulmonary Inst.
Jerusalem, , Israel
Hadassah Medical Center; Pulmonary Institute
Jerusalem, , Israel
Meir Medical Center; Pulmonary Dept
Kfar Saba, , Israel
Beilinson Medical Center; Pulmonary Inst.
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
A.O.U. Ospedali Riuniti Di Foggia-Ospedale D'avanzo; Malattie Dell'apparato Respiratorio IV
Foggia, Apulia, Italy
Ospedale Morgagni-Pierantoni; U.O. Pneumologia
Forlì, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio
Modena, Emilia-Romagna, Italy
Ospedale San Giuseppe; U.O. di Pneumologia
Milan, Lombardy, Italy
ASST DI MONZA; U O Clinica Pneumologica
Monza, Lombardy, Italy
A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone
Catania, Sicily, Italy
A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
Siena, Tuscany, Italy
Azienda Ospedaliera di Padova; Dip. Scienze Cardiologiche Toraciche Vascolari-UOC Pneumologia
Padua, Veneto, Italy
Vu Medisch Centrum; Afdeling Longziekten
Amsterdam, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
University of Cape Town Lung Institute; Lung Clinical Research
Cape Town, , South Africa
Milpark Hospital
Parktown West, , South Africa
University of Stellenbosch; Respiratory Research
Parow, , South Africa
Hospital Universitari de Bellvitge ; Servicio de Neumologia
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marques de Valdecilla; Servicio de neumologia
Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología
Majadahonda, Madrid, Spain
Hospital Clinic I provincial; Servicio de Neumologia
Barcelona, , Spain
Hospital Universitario la Fe; Servicio de Neumologia
Valencia, , Spain
Ankara Uni Faculty of Medicine; Chest Diseases
Ankara, , Turkey (Türkiye)
Uludag University; Pulmonology and Allergy Department
Bursa, , Turkey (Türkiye)
Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Capa Tıp Fakültesi; Gogus Hastalıkları Anabilim dalı
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tıp Fakültesi; Gögüs Hastalıkları Bilim Dalı
Izmir, , Turkey (Türkiye)
Countries
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References
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Behr J, Nathan SD, Costabel U, Albera C, Wuyts WA, Glassberg MK, Haller H Jr, Alvaro G, Gilberg F, Samara K, Lancaster L. Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies. Adv Ther. 2023 Sep;40(9):3937-3955. doi: 10.1007/s12325-023-02565-3. Epub 2023 Jun 30.
Behr J, Nathan SD, Wuyts WA, Mogulkoc Bishop N, Bouros DE, Antoniou K, Guiot J, Kramer MR, Kirchgaessler KU, Bengus M, Gilberg F, Perjesi A, Harari S, Wells AU. Efficacy and safety of sildenafil added to pirfenidone in patients with advanced idiopathic pulmonary fibrosis and risk of pulmonary hypertension: a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Respir Med. 2021 Jan;9(1):85-95. doi: 10.1016/S2213-2600(20)30356-8. Epub 2020 Aug 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-005131-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MA29957
Identifier Type: -
Identifier Source: org_study_id