Interstitial Lung Disease Clinical Trial
— BUILD 2 OLOfficial title:
Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.
Verified date | April 2015 |
Source | Actelion |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.
Status | Completed |
Enrollment | 132 |
Est. completion date | February 2006 |
Est. primary completion date | February 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - To have completed the 12-month treatment period of the AC-052-330/BUILD 2. - Women should not be pregnant - Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception - Signed informed consent prior to initiation of any study-mandated procedure Exclusion Criteria: - Any major violation of the protocol AC-052-330. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Eric Rich, MD | Montreal | Quebec |
France | Centre Hospitalier Universitaire | Grenoble | |
France | CHRU Claude Huriez | Lille | |
France | Hôpital Cochin | Paris | |
France | Hôpital Saint Antoine | Paris | |
Germany | Charité Universitätsklinikum | Berlin | |
Israel | Rabin Medical Center | Petach Tikva | |
Italy | Instituto di Clinica, Villa Monna Tessa | Firenze | |
Italy | Ospedale Maggiore | Milano | |
Italy | Policlinico Universitario | Padova | |
Korea, Republic of | SoonChunHyang University Bucheon Hospital | Gyeonggi-do | |
Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
Korea, Republic of | 7003 - Asan Medical Center | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Netherlands | Sint Maartenskliniek | Nijmegen | |
Sweden | University Hospital | Lund | |
Switzerland | University Hospital | Zurich | |
United Kingdom | General Infirmary | Leeds | |
United Kingdom | Royal Free Hospital | London | |
United States | Lee Shapiro, MD | Albany | New York |
United States | University of Michigan Health System - Division of Pulmonary & Critical Care Medicine | Ann Arbor | Michigan |
United States | University of Alabama | Birmingham | Alabama |
United States | Medical Univ of South Carolina | Charleston | South Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Illinois College of Medicine | Chicago | Illinois |
United States | The Cleveland Clinic | Cleveland | Ohio |
United States | Denver Health Medical Center | Denver | Colorado |
United States | Maureen Mayes, MD | Houston | Texas |
United States | UCLA Med School | Los Angeles | California |
United States | Jackson Memorial Hospital | Miami | Florida |
United States | UMDNJ | New Brunswick | New Jersey |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | University of Washington - Division of Pulmonary & Critical Care Medicine | Seattle | Washington |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | Georgetown University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Actelion |
United States, Canada, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, Sweden, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline to all assessed time points in 6-minute walk test distance. | |||
Primary | Change from baseline to all assessed time points in Borg dyspnea index, FVC and DLco, SpO2 at rest and de-saturation index (6-minute walk distance multiplied by SpO2 mean value). | |||
Primary | Transition Dyspnea Index at all assessed time points. | |||
Primary | Change from baseline to all assessed time points in SpO2 mean value, time to de-saturation (decrease in SpO2 = 4%), trough SpO2 and area under the curve during 6-minute walk test. | |||
Secondary | Adverse events; serious adverse events. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04905693 -
Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
|
Phase 3 | |
Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
Recruiting |
NCT05417776 -
Collagen-targeted PET Imaging for Early Interstitial Lung Disease
|
Phase 2 | |
Not yet recruiting |
NCT04089826 -
Long Term Oxygen Therapy in Patients With Interstitial Lung Disease
|
||
Recruiting |
NCT03467880 -
Multicenter Study of Impulse Oscillometry in Chinese
|
N/A | |
Completed |
NCT00883129 -
Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)
|
Phase 2 | |
Completed |
NCT00362739 -
Blood Collection From Individuals With Lung Disease for Genetic Studies
|
N/A | |
Recruiting |
NCT06133998 -
Effects of Incentive Spirometry With and Without Aerobic Exercises in Interstitial Lung Disease
|
N/A | |
Active, not recruiting |
NCT03485378 -
Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease
|
N/A | |
Recruiting |
NCT04098094 -
Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
|
||
Recruiting |
NCT03400839 -
Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases
|
||
Terminated |
NCT02633293 -
An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
|
Phase 2/Phase 3 | |
Enrolling by invitation |
NCT05001009 -
Goals of Care Conversations Study
|
N/A | |
Active, not recruiting |
NCT05068869 -
Digital Outpatient Services
|
N/A | |
Active, not recruiting |
NCT03727568 -
Study Comparing Two Different Methods of Cryobiopsy in the Interstitial Lung Diseases
|
N/A | |
Recruiting |
NCT06046547 -
Integrating Palliative Care Education in Pulmonary Rehabilitation
|
N/A | |
Completed |
NCT04946708 -
Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients
|
N/A | |
Recruiting |
NCT04139356 -
The Effect of Spontaneous Respiration on Pulse-oximetry Measurements
|
N/A | |
Recruiting |
NCT03726398 -
CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03295279 -
WTC Chest CT Imaging Archive
|