Idiopathic Pulmonary Fibrosis Clinical Trial
— MUSICOfficial 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.
Status | Completed |
Enrollment | 178 |
Est. completion date | August 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Signed informed consent. 2. Male or female patients of at least 18 years of age (females of child-bearing potential must use a reliable method of contraception). 3. 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. Exclusion Criteria: 1. Interstitial lung disease due to conditions other than IPF. 2. Presence of extensive honeycombing on Baseline high-resolution computed tomography (HRCT) scan performed within 3 months prior to randomization. 3. Severe concomitant illness limiting life expectancy (< 1 year). 4. Severe restrictive lung disease: forced vital capacity (FVC) < 50% predicted, or FVC < 1.2 liter. 5. Diffusing capacity of the lung for carbon monoxide (DLCO) < 30% predicted. 6. Residual volume = 120% predicted. 7. Obstructive lung disease: forced expiratory volume in 1 second (FEV1)/FVC) < 0.70. 8. Documented sustained improvement of the patient's IPF condition up to 12 months prior to randomization with or without IPF-specific therapy. 9. Recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to randomization). 10. Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements (e.g., pulmonary function tests). 11. Chronic heart failure with New York Heart Association class III/IV or known left ventricular ejection fraction < 25%. 12. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C. 13. Estimated creatinine clearance < 30 mL/min. 14. Aspartate aminotransferase (AST) and/or alanine aminotransferase > 1.5 x upper limit of normal. 15. Hemoglobin < 75% of the lower limit of the normal range. 16. Systolic blood pressure < 100 mmHg. 17. Pregnant or breast-feeding. 18. Current drug or alcohol dependence. 19. 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 a blockers, imatinib and interferon ?, - Chronic use of N-acetylcysteine prescribed for IPF (> 600 mg/day). - Oral anticoagulants prescribed for IPF. 20. Treatment with endothelin receptor antagonists within 4 weeks prior to randomization. 21. Systemic treatment within 4 weeks prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mammalian target of rapamycin (mTOR) inhibitors). 22. Treatment with Cytochrome P450 3A inducers within 4 weeks prior to randomization. 23. Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients. 24. Planned treatment, or treatment with another investigational drug within 4 weeks prior to randomization. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Prince Charles Hospital Lung Transplant | Chermside | |
Australia | St. Vincent's Public Hospital | Darlinghurst | |
Australia | The Alfred Hospital | Melbourne | |
Australia | Royal Perth Hospital | Perth | |
Canada | University of Alberta - Health Sciences Center | Edmonton | Alberta |
Canada | St. Joseph's Healthcare | Hamilton | Ontario |
Canada | Kelowna General Hospital | Kelowna | British Columbia |
Canada | Hospital Notre-Dame du CHUM | Montreal | Quebec |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | St. Paul's Hospital | Vancouver | British Columbia |
France | Hopital Avicenne | Bobigny | |
France | Hôpital Cardiologique et Pneumologique Louis Pradel | Bron | |
France | CHRU - Hopital Calmette Clinique des Maladies Respiratoires | Lille | |
Germany | Helios Klinikum Emil von Behring | Berlin | |
Germany | Justus-Liebig-Universität Gießen | Giessen | |
Germany | Fachklinik fur Lungenerkrankungen | Immenhausen | |
Germany | Universität zu Köln | Koln | |
Germany | Ludwig-Maximilian-Universität München | Munchen | |
Israel | 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 Hashomer | |
Italy | 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 | |
Slovenia | Bolnišnica Golnik | Golnik | |
South Africa | Centre for Chest Diseases, Milpark Hospital | Johannesburg | |
South Africa | Pretoria East Hospital | Pretoria | |
Spain | 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 | |
Sweden | Karolinska Universitetssjukhuset Lung Allergi kliniken | Stockholm | |
Turkey | Ankara University School of Medicine | Ankara | |
Turkey | Ege University School of Medicine | Izmir | |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | St. Luke's Medical Group | Chesterfield | Missouri |
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
United States | National Jewish Medical & Research Center | Denver | Colorado |
United States | Baylor College of Medicine - Baylor Clinic | Houston | Texas |
United States | University of Wisconsin - Madison | Madison | Wisconsin |
United States | Yale University School of Medicine | New Haven | Connecticut |
United States | Temple University Hospital - Lung Center | Philadelphia | Pennsylvania |
United States | Pulmonary Associates, P.A. | Phoenix | Arizona |
United States | U.C. Davis University of California | Sacramento | California |
United States | UCSD Pulmonary Critical Care | San Diego | California |
United States | University of California - San Francisco | San Francisco | California |
United States | Mayo Clinic - Arizona | Scottsdale | Arizona |
United States | Stanford University Medical Center - Chest Clinic | Stanford | California |
United States | Wichita Clinic P.A | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Actelion |
United States, Australia, Canada, France, Germany, Israel, Italy, Slovenia, South Africa, Spain, Sweden, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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). |
Up to end of study (Up to 24 months) | No |
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