Disease-syndrome Characteristics of IPF

NCT07178392 | Not Yet Recruiting DMC

• 1 other identifier: Characteristics of IPF
• Study Type: observational
• Target: 2,864
• Locations: 1 country
• Sites: 1

Brief Summary

This study, based on previous registration records, aims to explore the syndrome patterns, disease characteristics, and their interrelationships of IPF at different stages, grades, and in its natural course, thus providing a multidimensional interpretation of the syndrome patterns and characteristics of IPF.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Keywords

Idiopathic Pulmonary Fibrosis; TCM; Epidemiological investigation; characteristics

Outcome Measures

Primary Outcomes (18)

• Disease Stage

  Recording the disease staging of IPF patients. According to the Adult Idiopathic Pulmonary Fibrosis (Revised Edition) and Progressive Pulmonary Fibrosis: ATS/ERS/JRS/ALAT Official Clinical Practice Guidelines (2022 Edition), and the Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis, the disease staging evaluation of IPF is stable phase or acute exacerbation.

  Evaluate at baseline.

• Gender, age and physiologic variables (GAP)stage

  Recording the GAP stage of IPF patients. GAP stage is a risk stratification method that quantifies the three core parameters of patients: gender, age, and physiological parameters, by calculating the total score and conducting risk stratification.

  Evaluate at baseline.

• Pulmonary function classification

  Recording the pulmonary function classification of IPF patients. According to The Expert Consensus on the Diagnostic Criteria for Adult Lung Function in China, pulmonary function classification is divided into mild, moderate, and severe grades.

  Evaluate at baseline.

• Natural course

  Recording the natural course of IPF patient. According to international research, the natural course of IPF can be divided into stable, slow progression, rapid progression, and recurrent acute exacerbation. The specific criteria are as follows: 1.stable: FVC annual decline\<0.13L; 2. stable slow progression: FVC annual decline 0.13L-0.21L; 3. Rapid progress: FVC annual decline\>0.21L; 4. Recurrent acute exacerbations: Annual number of acute exacerbations ≥ 1.

  Evaluate at baseline.

• The Traditional Chinese Medicine(TCM) Syndromes

  Evaluate traditional Chinese medicine syndromes by collecting patients' symptoms, signs, and tongue pulse information.

  Evaluate at baseline.

• 6 Six Minute Walk Distance(6MWD)

  6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.

  Evaluate at baseline.

• The 30 - second sit - to - stand test(30s STS)

  The 30 second sitting and standing test will be used to evaluate lower limb strength and cardiopulmonary function.

  Evaluate at baseline.

• A Tool to Assess Quality of life (ATAQ-IPF) total scores

  ATAQ-IPF is currently a specialized scale for evaluating the quality of life, consisting of 13 dimensions and 74 items, with each item scored on a 1-5 scale. The higher the score, the worse the quality of life.

  Evaluate at baseline.

• St. George's respiratory questionnaire (SGRQ) total scores

  SGRQ is a scale used to evaluate the quality of life of patients, which includes three dimensions: symptoms, mobility, and the impact of disease on daily life, with a total of 50 items. The total score range of SGRQ is usually between 0 and 100, with higher scores leading to poorer quality of life.

  Evaluate at baseline.

• Dyspnea

  Dyspnea will be assessed by modified Medical Research Council(mMRC) scores. A score of 0-4 will be givenaccording to the degree of immediate dyspnea. A higher score indicates a worse condition.

  Evaluate at baseline.

• C-reactive protein (CRP)

  The CRP level will be detected by ELISA technology.

  Evaluate at baseline.

• Krebs Von den Lungen-6（KL-6）

  The KL-6 level will be detected by ELISA technology.

  Evaluate at baseline.

• The pulmonary artery systolic pressure(PASP)

  The PASP will be measured byechocardiogram.

  Evaluate at baseline.

• The diameter of the pulmonary artery

  The diameter of the pulmonary artery will be measured byechocardiogram.

  Evaluate at baseline.

• Forced vital capacity (FVC)

  FVC will be applied to assess pulmonary function.

  Evaluate at baseline.

• FVC as the percentage of the predicted value (FVC%)

  FVC% will be applied to assess pulmonary function.

  Evaluate at baseline.

• Diffusing capacity of the lungs for carbon monoxide (DLCO)

  DLCO will be applied to assess pulmonary function.

  Evaluate at baseline.

• DLCO as the percentage of the predicted value (DLCO%)

  DLCO% will be applied to assess pulmonary function.

  Evaluate at baseline.

Study Arms (1)

Participants fill out the questionnaire

Participants fill out the questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Idiopathic pulmonary fibrosis (IPF) is a special type of idiopathic interstitial pneumonia, which is mainly manifested by irritating dry cough and progressive dyspnea.

You may qualify if:

• Patients diagnosed with IPF;
• Age ≥ 18 years old;
• Voluntarily participate in this study and sign an informed consent form.

You may not qualify if:

• Patients with confusion, dementia, consciousness disorders, and various mental illnesses;
• Those who are unable to take care of themselves and have been bedridden for a long time.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator
• China-Japan Friendship Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Study Sites (1)

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood,Tongue coating

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

xueqing yu, Ph.D

CONTACT

+8613525518843; yxqshi@163.com

jiansheng li, Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: September 17, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

CN (1)