Interstitial Lung Disease Clinical Trial
Official title:
Randomized Controlled Trial of Pirfenidone in Patients With Progressive Interstitial Lung Disease Associated With Clinically Amyopathic Dermatomyositis
Interstitial lung disease (ILD) is a common complication of dermatomyositis (DM) with
prevalence up to 65%, and is considered to be one of the determining factors of prognosis.
Clinical amyopathic dermatomyositis (CADM), which is a special phenotype of DM, with
characteristic cutaneous manifestations but no or only subclinical myopathy. Many studies,
mainly from Asia, including ours, have demonstrated that these patients with CADM tend to
develop a rapidly progressive ILD (RPILD) and have a poor response to conventional therapy,
such as high-dose corticosteroids and immunosuppressants, leading to lethal outcome with a
6-month survival rate of less than 50%.
Pirfenidone, a new oral antifibrotic agent, has been approved for the treatment of
idiopathic pulmonary fibrosis (IPF). Randomized controlled trials of pirfenidone in patients
with IPF suggested that it could ameliorate pulmonary function decline and improve the
progression-free survival. Its utility in connective tissue disease (CTD) related ILD has
been implicated, but no evidence has yet demonstrated its efficacy. Therefore, the
investigators conduct this study to evaluate the possible therapeutic effects of pirfenidone
on RPILD associated with CADM.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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
|