Acute exacerbation of idiopathic pulmonary fibrosis
Conditions
Interventions
rhTM was administered intravenously (diluted in 100 mL of sterile saline) at a dose of 0.06mg/kg/day for the first 6 days, in combination with CS therapy.
Sponsors
Division of Respiratory Medicine, Toho University Omori Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) a previous or current diagnosis of IPF, (2) unexplained worsening or development of dyspnea during the past 30 days, (3) an HRCT scan showing new bilateral ground-glass opacities and/or consolidation superimposed on a background reticular or honeycomb pattern, (4) no evidence of pulmonary infection on bronchoalveolar lavage, endotracheal aspiration, or sputum culture and negative results on blood tests for other potentially infectious pathogens (eg, pneumocystis jiroveci, cytomegalovirus), and (5) exclusion of left heart failure, pulmonary embolism, and other possible causes of acute lung injury.
Exclusion criteria
Exclusion criteria: (1) coexisting life-threatening bleeding (pulmonary, gastrointestinal, or intracranial), history of cerebrovascular disorders during the previous 6 months, pregnancy, decompensated liver cirrhosis, and renal failure or other serious organ dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-month survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month, overall survival. Safety of rhTM | — |
Countries
Japan
Contacts
Public ContactSusumu Sakamoto
Toho University Omori Medical Center Division of Respiratory Medicine
Outcome results
None listed