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The efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trial

The efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027121
Enrollment
Unknown
Registered
2019-11-01
Start date
2019-10-28
Completion date
Unknown
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nonspecific interstitial pneumonia (NSIP)

Interventions

Group-1:Mycophenolate mofetil dispersible tablets 2 g /d
Steroid 0.75 mg/kg/d
Group-2:Tacrolimus capsule, 3mg/d, Steroid 0.75 mg/kg/d
Group-3:Cyclophosphamide 1-2mg/kg/d, Steroid 0.75 mg/kg/d
Control group:Steroid from 0.75 mg/kg/d to 15 mg/d.

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Subjects should meet the following criteria in order to participate in this study. 1. Subjects are willing to participate and use medication and follow-up time according to the treatment plan, and sign the informed consent; 2. In line with the NSIP diagnostic criteria, seeing Appendix 1 for details; 3. Aged 18-75 years; 4. No immunosuppressants and biological agents were used at the time of screening or had been discontinued for 3 months (including newly diagnosed untreated patients and patients with immunosuppressive immunosuppressive agents for 3 months or more); 5. Women of childbearing age must have a negative urine pregnancy test, and patients with pregnancy needs to voluntarily use commonly accepted contraceptive measures.

Exclusion criteria

Exclusion criteria: Objects may not participate in research if they have one of the following conditions: 1. Patients who have ILD with clear etiology, such as connective tissue disease (CTD), HIV, GVHD, etc.; 2. Extrapulmonary lesions other than interstitial pneumonia: (1) moderate to severe pulmonary hypertension requires special treatment; (2) UIP, IPF and other pathological types of IIPs; (3) people with severe lung disease, such as tumors and active lung infections; (4) lung biopsy, alveolar lavage or HRCT suggest severe lung disease other than interstitial lung disease; 3. There are serious organs, liver, kidney and other important organs and blood, endocrine system lesions; 4. In the acute exacerbation of interstitial lung disease, such as acute respiratory distress syndrome (ARDS); 5. Those who are known to be allergic or intolerant to immunosuppressive agents, patients with severe autoimmune diseases; 6. Mental disorders or can not cooperate with the treatment; 7. Pregnant/lactating women, or those who are unable to guarantee effective contraception during childbearing age.

Design outcomes

Primary

MeasureTime frame
Forced vital capacity (FVC);

Secondary

MeasureTime frame
Videography improvement;Dyspnea score;

Countries

China

Contacts

Public ContactZuojun Xu

Peking Union Medical College Hospital

xuzj@hotmail.com+86 13671345136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026