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Idiopathic Pulmonary FibrosisPhase 2MUSICNCT00903331

Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study

A Phase 2 study testing ACT-064992 (macitentan) in people with Idiopathic Pulmonary Fibrosis, run by Actelion at 53 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
ACT-064992 (macitentan)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
178 participants
Where
53 sitesin 12 countries
Study dates
May 2009to Aug 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 29Show fewer
  • 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.
  • Systolic blood pressure < 100 mmHg.
  • Pregnant or breast-feeding.
  • Current drug or alcohol dependence.
  • Chronic treatment with the following drugs (within 4 weeks of randomization):
  • Oral corticosteroids (> 20 mg/day of prednisone or equivalent),
  • Immunosuppressive or cytotoxic drugs including cyclophosphamide and azathioprine,
  • Antifibrotic drugs including pirfenidone, D penicillamine, colchicine, tumor necrosis factor α blockers, imatinib and interferon γ,
  • Chronic use of N-acetylcysteine prescribed for IPF (> 600 mg/day).
  • Oral anticoagulants prescribed for IPF.
  • Treatment with endothelin receptor antagonists within 4 weeks prior to randomization.
  • Systemic treatment within 4 weeks prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mammalian target of rapamycin (mTOR) inhibitors).
  • Treatment with Cytochrome P450 3A inducers within 4 weeks prior to randomization.
  • Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
  • Planned treatment, or treatment with another investigational drug within 4 weeks prior to randomization.

Trial locations and contacts

53 sites in 12 countries.

53 sites in 12 countries

United States15 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • St. Luke's Medical Group

    Chesterfield, Missouri, 63017

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • National Jewish Medical & Research Center

    Denver, Colorado, 80206

  • Baylor College of Medicine - Baylor Clinic

    Houston, Texas, 77030

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Temple University Hospital - Lung Center

    Philadelphia, Pennsylvania, 19140

  • Pulmonary Associates, P.A.

    Phoenix, Arizona, 85006

  • U.C. Davis University of California

    Sacramento, California, 95817

  • UCSD Pulmonary Critical Care

    San Diego, California, 92103

  • University of California - San Francisco

    San Francisco, California, 94143

  • Mayo Clinic - Arizona

    Scottsdale, Arizona, 85259

  • Stanford University Medical Center - Chest Clinic

    Stanford, California, 94305

  • Wichita Clinic P.A

    Wichita, Kansas, 67208

Other trials in United States

Canada6 sites

  • University of Alberta - Health Sciences Center

    Edmonton, Alberta, T6G2B7

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N4A6

  • Kelowna General Hospital

    Kelowna, British Columbia, V1W3T1

  • Hospital Notre-Dame du CHUM

    Montreal, Quebec, H2L4M1

  • Toronto General Hospital

    Toronto, Ontario, M5G2N2

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z1Y6

Other trials in Canada

Germany5 sites

  • Helios Klinikum Emil von Behring

    Berlin

  • Universität zu Köln

    Cologne

  • Justus-Liebig-Universität Gießen

    Giessen

  • Fachklinik fur Lungenerkrankungen

    Immenhausen

  • Ludwig-Maximilian-Universität München

    München

Other trials in Germany

Israel5 sites

  • Hadassah Ein Kerem Medical Center

    Jerusalem

  • Rabin Medical Center, Beilinson Hospital

    Petach Tikvah

  • Kaplan Medical Center

    Rehovot

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv

  • The Chaim Sheba Medical Center

    Tel HaShomer

Other trials in Israel

Spain5 sites

  • Hospital Clinic I Provincial de Barcelona

    Barcelona

  • Hospital General Vall d'Hebron

    Barcelona

  • Fundación Hospital Alcorcón

    Madrid

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid

Other trials in Spain

Australia4 sites

  • Prince Charles Hospital Lung Transplant

    Chermside

  • St. Vincent's Public Hospital

    Darlinghurst

  • The Alfred Hospital

    Melbourne

  • Royal Perth Hospital

    Perth

Other trials in Australia

Italy4 sites

  • Ospedale San Giuseppe Milanocuore

    Milan

  • Università degli Studi di Torino Clinica di Malattie dell'Apparato Respiratorio

    Orbassano

  • A.O.U Policlinico Tor Vergata

    Roma

  • Ospedale di Cattinara

    Trieste

Other trials in Italy

France3 sites

  • Hopital Avicenne

    Bobigny

  • Hôpital Cardiologique et Pneumologique Louis Pradel

    Bron

  • CHRU - Hopital Calmette Clinique des Maladies Respiratoires

    Lille

Other trials in France

South Africa2 sites

  • Centre for Chest Diseases, Milpark Hospital

    Johannesburg

  • Pretoria East Hospital

    Pretoria

Other trials in South Africa

Turkey (Türkiye)2 sites

  • Ankara University School of Medicine

    Ankara

  • Ege University School of Medicine

    Izmir

Other trials in Turkey (Türkiye)

Slovenia1 site

  • Bolnišnica Golnik

    Golnik

Other trials in Slovenia

Sweden1 site

  • Karolinska Universitetssjukhuset Lung Allergi kliniken

    Stockholm

Other trials in Sweden

About this study

Official title: 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

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.

Read the detailed description

The study included two treatment periods: Period 1 (fixed duration) from randomization up to the primary endpoint evaluation (Month 12 or earlier in case of premature discontinuation of study drug) and Period 2 (variable duration) from the primary endpoint evaluation visit up to the end of study (EOS). EOS occurred when the last patient randomized and not prematurely discontinued completed Period 1.

Being tested
ACT-064992 (macitentan), Placebo
Keywords
idiopathic pulmonary fibrosis, MUSIC
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT-064992 (macitentan)Drug

    Also called macitentan

    ACT-064992 (macitentan) tablet, 10 mg, once daily

  • PlaceboDrug

    matching placebo, once daily

Study groups in NCT00903331
Study groupRoleWhat they receive
ACT-064922ExperimentalACT-064922 tablet (macitentan), 10 mg, once daily
Receives: Drug: ACT-064992 (macitentan)
PlaceboPlacebo comparatorMatching placebo, once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (1)

  1. Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study

    Disease worsening was indicated by pulmonary function test/idiopathic pulmonary fibrosis worsening (PFT/IPF) or acute respiratory decompensation of IPF.

    PFT/IPF worsening was indicated by the occurrence of both of the following: confirmed by two tests at least 4 weeks apart, as defined by the occurrence of both of the following: decrease from baseline ≥ 10% in forced vital capacity and decrease from baseline ≥ 15% in corrected diffusing capacity of the lung for carbon monoxide.

    Acute respiratory decompensation of IPF was defined as an unexplained rapid deterioration (over a period of less than 4 weeks) of the patient's condition with increasing shortness of breath requiring oxygen supplementation ≥ 5 L/min to maintain a resting oxygen saturation ≥ 90% or arterial oxygen pressure ≥ 55 mmHg (sea level) or 50 mmHg (high altitude).

    Measured: Up to end of study (Up to 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionJun 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00903331
Sponsor's protocol ID
AC-055B201
Acronym
MUSIC
Status last verified
Jan 2014
First submitted
14 May 2009
Last updated
17 Feb 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23682110

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACT-064992 (macitentan) in people with Idiopathic Pulmonary Fibrosis, run by Actelion at 53 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Canada, Germany, Israel, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Vital Capacity (FVC) at Baseline and End of Period 1 (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00903331, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2014.

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