Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study
MUSIC
A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
1 other identifier
interventional
178
12 countries
53
Brief Summary
The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF). The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF, and to evaluate the benefit/risk profile of macitentan in the treatment of patients with IPF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2009
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
February 17, 2014
CompletedFebruary 17, 2014
January 1, 2014
2.1 years
May 14, 2009
October 29, 2013
January 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced Vital Capacity (FVC) at Baseline and End of Period 1
FVC was measured at baseline and at the end of Period 1. The same equipment and tester were used during the course of the study. The equipment was calibrated and the calibration documented prior to each patient's measurement. The person responsible for conducting the pulmonary function tests was required to comply with the study guidelines and the American Thoracic Society/European Respiratory Society joint criteria on lung function testing.
12 months
Secondary Outcomes (1)
Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study
Up to end of study (Up to 24 months)
Study Arms (2)
ACT-064922
EXPERIMENTALACT-064922 tablet (macitentan), 10 mg, once daily
Placebo
PLACEBO COMPARATORMatching placebo, once daily
Interventions
ACT-064992 (macitentan) tablet, 10 mg, once daily
Eligibility Criteria
You may qualify if:
- Signed informed consent.
- Male or female patients of at least 18 years of age (females of child-bearing potential must use a reliable method of contraception).
- IPF diagnosis within 3 years prior to randomization, proven according to the American Thoracic Society/European Respiratory Society consensus conference criteria, with surgical lung biopsy.
You may not qualify if:
- Interstitial lung disease due to conditions other than IPF.
- Presence of extensive honeycombing on Baseline high-resolution computed tomography (HRCT) scan performed within 3 months prior to randomization.
- Severe concomitant illness limiting life expectancy (\< 1 year).
- Severe restrictive lung disease: forced vital capacity (FVC) \< 50% predicted, or FVC \< 1.2 liter.
- Diffusing capacity of the lung for carbon monoxide (DLCO) \< 30% predicted.
- Residual volume ≥ 120% predicted.
- Obstructive lung disease: forced expiratory volume in 1 second (FEV1)/FVC) \< 0.70.
- Documented sustained improvement of the patient's IPF condition up to 12 months prior to randomization with or without IPF-specific therapy.
- Recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to randomization).
- Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements (e.g., pulmonary function tests).
- Chronic heart failure with New York Heart Association class III/IV or known left ventricular ejection fraction \< 25%.
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
- Estimated creatinine clearance \< 30 mL/min.
- Aspartate aminotransferase (AST) and/or alanine aminotransferase \> 1.5 x upper limit of normal.
- Hemoglobin \< 75% of the lower limit of the normal range.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actelionlead
Study Sites (53)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Pulmonary Associates, P.A.
Phoenix, Arizona, 85006, United States
Mayo Clinic - Arizona
Scottsdale, Arizona, 85259, United States
U.C. Davis University of California
Sacramento, California, 95817, United States
UCSD Pulmonary Critical Care
San Diego, California, 92103, United States
University of California - San Francisco
San Francisco, California, 94143, United States
Stanford University Medical Center - Chest Clinic
Stanford, California, 94305, United States
National Jewish Medical & Research Center
Denver, Colorado, 80206, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Wichita Clinic P.A
Wichita, Kansas, 67208, United States
St. Luke's Medical Group
Chesterfield, Missouri, 63017, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Temple University Hospital - Lung Center
Philadelphia, Pennsylvania, 19140, United States
Baylor College of Medicine - Baylor Clinic
Houston, Texas, 77030, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792, United States
Prince Charles Hospital Lung Transplant
Chermside, Australia
St. Vincent's Public Hospital
Darlinghurst, Australia
The Alfred Hospital
Melbourne, Australia
Royal Perth Hospital
Perth, Australia
University of Alberta - Health Sciences Center
Edmonton, Alberta, T6G2B7, Canada
Kelowna General Hospital
Kelowna, British Columbia, V1W3T1, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6, Canada
St. Joseph's Healthcare
Hamilton, Ontario, L8N4A6, Canada
Toronto General Hospital
Toronto, Ontario, M5G2N2, Canada
Hospital Notre-Dame du CHUM
Montreal, Quebec, H2L4M1, Canada
Hopital Avicenne
Bobigny, France
Hôpital Cardiologique et Pneumologique Louis Pradel
Bron, France
CHRU - Hopital Calmette Clinique des Maladies Respiratoires
Lille, France
Helios Klinikum Emil von Behring
Berlin, Germany
Universität zu Köln
Cologne, Germany
Justus-Liebig-Universität Gießen
Giessen, Germany
Fachklinik fur Lungenerkrankungen
Immenhausen, Germany
Ludwig-Maximilian-Universität München
München, Germany
Hadassah Ein Kerem Medical Center
Jerusalem, Israel
Rabin Medical Center, Beilinson Hospital
Petach Tikvah, Israel
Kaplan Medical Center
Rehovot, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, Israel
Ospedale San Giuseppe Milanocuore
Milan, Italy
Università degli Studi di Torino Clinica di Malattie dell'Apparato Respiratorio
Orbassano, Italy
A.O.U Policlinico Tor Vergata
Roma, Italy
Ospedale di Cattinara
Trieste, Italy
Bolnišnica Golnik
Golnik, Slovenia
Centre for Chest Diseases, Milpark Hospital
Johannesburg, South Africa
Pretoria East Hospital
Pretoria, South Africa
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain
Hospital General Vall d'Hebron
Barcelona, Spain
Fundación Hospital Alcorcón
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Karolinska Universitetssjukhuset Lung Allergi kliniken
Stockholm, Sweden
Ankara University School of Medicine
Ankara, Turkey (Türkiye)
Ege University School of Medicine
Izmir, Turkey (Türkiye)
Related Publications (1)
Raghu G, Million-Rousseau R, Morganti A, Perchenet L, Behr J; MUSIC Study Group. Macitentan for the treatment of idiopathic pulmonary fibrosis: the randomised controlled MUSIC trial. Eur Respir J. 2013 Dec;42(6):1622-32. doi: 10.1183/09031936.00104612. Epub 2013 May 16.
PMID: 23682110DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Parisa Danaietash
- Organization
- Actelion Pharmaceuticals Ltd
Study Officials
- STUDY CHAIR
Loic Perchenet, Ph.D.
Actelion
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 18, 2009
Study Start
May 1, 2009
Primary Completion
June 1, 2011
Study Completion
August 1, 2011
Last Updated
February 17, 2014
Results First Posted
February 17, 2014
Record last verified: 2014-01