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Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04413149
Enrollment
80
Registered
2020-06-02
Start date
2014-04-01
Completion date
2020-04-01
Last updated
2024-05-17

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

Conditions

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

Keywords

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

Brief 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.

Detailed 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

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Death From All CausesFrom baseline until the date of death from all cause, up to 5 yearsDeath from all causes Retrieved from medical records.
Number of Patients Who Underwent Lung TransplantationFrom baseline until the date of transplantation, up to 5 yearsNumber of patients who underwent lung transplantation Retrieved from medical records.

Countries

China

Participant flow

Participants by arm

ArmCount
MPA-ILD Group
Among all the patients with ANCA-positive ILD, patients who fulfilled the MPA criteria were defined as MPA-ILD group.
31
ANCA-IIP Group
Patients with isolated ANCA-positivity who did not fulfill the MPA criteria were classified as ANCA-IIP group.
49
Total80

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath105
Overall StudyLung transplantation10

Baseline characteristics

CharacteristicTotalMPA-ILD GroupANCA-IIP Group
Age, Continuous60 years62 years59 years
ANA positive45 Participants15 Participants30 Participants
Anti-CCP positive8 Participants0 Participants8 Participants
Arthralgia23 Participants8 Participants15 Participants
Cardiovascular involvement2 Participants2 Participants0 Participants
Clubbing fingers7 Participants5 Participants2 Participants
Consolidation8 Participants4 Participants4 Participants
Cough70 Participants28 Participants42 Participants
Crackling sound45 Participants19 Participants26 Participants
C reactive protein15.92 mg/dL35.77 mg/dL13.87 mg/dL
Creatinine68 μmol/L73 μmol/L67 μmol/L
Curved linear opacity17 Participants5 Participants12 Participants
DLCO60.12 percent predicted
STANDARD_DEVIATION 15.53
56.56 percent predicted
STANDARD_DEVIATION 17.52
62.12 percent predicted
STANDARD_DEVIATION 14.09
Dyspnea49 Participants20 Participants29 Participants
Enlarged mediastinal lymph node5 Participants2 Participants3 Participants
Erythrocyte sedimentation rate53 mm/h86 mm/h28 mm/h
Fatigue11 Participants6 Participants5 Participants
FEV182.35 percent predicted
STANDARD_DEVIATION 17.32
79.36 percent predicted
STANDARD_DEVIATION 17.92
84.03 percent predicted
STANDARD_DEVIATION 16.93
Fever26 Participants16 Participants10 Participants
Follow-up time40 months36 months41 months
FVC81.85 percent predicted
STANDARD_DEVIATION 18.42
78.30 percent predicted
STANDARD_DEVIATION 16.89
83.84 percent predicted
STANDARD_DEVIATION 19.1
Gottron's sign3 Participants1 Participants2 Participants
Ground-glass opacity69 Participants25 Participants44 Participants
Hemoglobin132 g/L116 g/L137 g/L
Honeycombing19 Participants11 Participants8 Participants
Interlobular septal thickening39 Participants16 Participants23 Participants
Jo-1 positive1 Participants0 Participants1 Participants
Lymphocyte1.90 ×10^9 cells/L1.47 ×10^9 cells/L2 ×10^9 cells/L
Mechanics hand2 Participants0 Participants2 Participants
Micronodular pattern11 Participants5 Participants6 Participants
MPO-ANCA positive45 Participants26 Participants19 Participants
Nervous system involvement3 Participants3 Participants0 Participants
Neutrophil5.65 ×10^9 cells/L6.79 ×10^9 cells/L4.68 ×10^9 cells/L
Nonspecific interstitial pneumonia51 Participants18 Participants33 Participants
PaO275.9 mmHg71.5 mmHg77.4 mmHg
Platelet246 ×10^9 cells/L251 ×10^9 cells/L234 ×10^9 cells/L
Pleural thickening13 Participants4 Participants9 Participants
PR3-ANCA positive2 Participants0 Participants2 Participants
Pulmonary artery dilation4 Participants3 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
80 Participants31 Participants49 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Rash10 Participants3 Participants7 Participants
Region of Enrollment
China
80 participants31 participants49 participants
Renal involvement30 Participants30 Participants0 Participants
Reticular pattern49 Participants20 Participants29 Participants
Retinal involvement1 Participants1 Participants0 Participants
Rheumatoid factor55.9 IU/mL113.1 IU/mL26.7 IU/mL
Scl-70 positive2 Participants1 Participants1 Participants
Sex: Female, Male
Female
44 Participants19 Participants25 Participants
Sex: Female, Male
Male
36 Participants12 Participants24 Participants
SSA positive9 Participants3 Participants6 Participants
SSB positive4 Participants2 Participants2 Participants
Subpleural bulla20 Participants10 Participants10 Participants
TLC77.59 percent predicted
STANDARD_DEVIATION 13.43
74.16 percent predicted
STANDARD_DEVIATION 12.73
79.53 percent predicted
STANDARD_DEVIATION 13.55
Traction bronchiectasis36 Participants16 Participants20 Participants
Unclassifiable HRCT pattern22 Participants9 Participants13 Participants
Usual interstitial pneumonia7 Participants4 Participants3 Participants
White blood cell8.54 ×10^9 cells/L9.34 ×10^9 cells/L7.44 ×10^9 cells/L

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
10 / 315 / 49
other
Total, other adverse events
0 / 310 / 49
serious
Total, serious adverse events
0 / 310 / 49

Outcome results

Primary

Death From All Causes

Death from all causes Retrieved from medical records.

Time frame: From baseline until the date of death from all cause, up to 5 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
MPA-ILD GroupDeath From All Causes10 Participants
ANCA-IIP GroupDeath From All Causes5 Participants
Primary

Number of Patients Who Underwent Lung Transplantation

Number of patients who underwent lung transplantation Retrieved from medical records.

Time frame: From baseline until the date of transplantation, up to 5 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
MPA-ILD GroupNumber of Patients Who Underwent Lung Transplantation1 Participants
ANCA-IIP GroupNumber of Patients Who Underwent Lung Transplantation0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026