Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.

Interstitial Lung Disease Clinical Trial

Official title:

Observational Study of Clinical Features and Outcome of Interstitial Lung Disease With Anti-neutrophil Cytoplasmic Antibody in Chinese Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413149
• Other study ID #: PUMCH-ANCA-positive ILD
• Status: Completed
• Start date: April 1, 2014
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2024
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the clinical features and long-term outcome of anti-neutrophil cytoplasmic antibody (ANCA)-positive interstitial lung disease (ILD) and assess the difference between microscopic polyangiitis (MPA) associated ILD and isolated ANCA-positive idiopathic interstitial pneumonia.

Description:

ILD patients with serum ANCA-positivity were enrolled in this study.

1. Baseline data collection:

1. Demographics information (age, gender)

2. Clinical course

3. Clinical symptoms and signs (cough, dyspnea, fever, fatigue, crackling, clubbing fingers, mechanics hand)

4. Laboratory findings (blood and urine routine, liver and renal function tests, erythrocyte sedimentation rate, C reactive protein)

5. Serologic tests (ANA , Rheumatoid factor , Anti-cyclic citrullinated peptide (CCP), Anti-dsDNA, Anti-Ro (SS-A), Anti-La (SS-B), Anti-Smith, Anti-Scl-70, Anti-Jo-1)

6. Systemic manifestation if diagnosed as systemic vasculitis

7. Pulmonary function tests (ventilation and diffusion capacity test)

8. Chest high-resolution computed tomography (HRCT)

2. Treatment: treatment will be given according to the experience of each pulmonologist.

3. Follow-up:

1. Patients were followed up at least once a year and basic laboratory tests, serologic autoantibodies, pulmonary function test and chest HRCT were evaluated routinely

2. Follow-up end point was April 2019.

4. Outcome

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Males and females

• Aged from 18 to 85 years with informed consent

• Have a diagnosis of ILD based on clinical symptoms and radiologic features, with or without histopathologic results

• Have available ANCA testing results during the first visit and follow-up period

Exclusion Criteria:

• Connective tissue disease associated ILD

• ILD induced by drug, environment, or occupational exposure

• Hypersensitivity pneumonitis and sarcoidosis

Related Conditions & MeSH terms

• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Vasculitis

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death From All Causes	Death from all causes Retrieved from medical records.	From baseline until the date of death from all cause, up to 5 years
Primary	Number of Patients Who Underwent Lung Transplantation	Number of patients who underwent lung transplantation Retrieved from medical records.	From baseline until the date of transplantation, up to 5 years