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NCT Number: NCT06577753

REspiratory diSEAse cohoRt Studies of CHinese Medicine for ILD (RESEARCH-ILD)

This study is a traditional Chinese medicine cohort for interstitial lung disease（ILD） in China, including at least 5000 patients with ILD and followed up for at least 5 years. The aim is to focus on the demographic characteristics, clinical features, disease occurrence and development characteristics, TCM syndrome evolution patterns, and clinical efficacy of TCM treatment for ILD in the real world.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

Location status: Recruiting

Location contact

Xue-qing Yu, Ph.D

CONTACT

[email protected]

+8613525518843

About this study

This study focuses on ILD patients and adopts a prospective cohort study design, with traditional Chinese medicine treatment as the exposure factor. The subjects are divided into a traditional Chinese medicine cohort and a non traditional Chinese medicine cohort, with demographic characteristics, mortality rate, lung transplant rate, annual acute exacerbation frequency, traditional Chinese medicine syndrome, 6MWT, lung function, dyspnea score, quality of life, and other observation indicators. Follow up for at least 5 years will be conducted, and at least 5000 ILD patients will be included, focusing on the demographic characteristics, clinical characteristics, disease occurrence and development characteristics, traditional Chinese medicine syndrome evolution rules, and clinical efficacy of traditional Chinese medicine treatment for ILD in the real world.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who meet the diagnosis of ILD;
  • Age≥18 years old;
  • Ability to provide independent informed consent.

Exclusion criteria

Patients with acute ILD caused by known reasons, but the lesions disappear within 2 weeks after treatment. Example: Interstitial pneumonia caused by infections such as mycoplasma/virus, and those who recover after treatment are excluded.

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.

    The all-cause mortality will be recorded.

  2. Lung transplantation

    Time frame: Up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.

    The lung transplantation will be calculated in each cohort at the end of the trial.

Secondary outcomes

  1. Frequencies of acute exacerbations (AEs)

    Time frame: The frequencies of acute exacerbations at weeks 13, 26, 39, 52, 65, 78, 91 and 104.

    The frequencies of acute exacerbations (AEs) will be recorded. The diagnostic criteria for acute exacerbation refer to the 2016 international consensus and the 2019 Chinese expert consensus.

  2. Proportion of progressive-free survival

    Time frame: The Proportion of progressive-free survival at weeks 13, 26, 39, 52, 65, 78, 91 and 104.

    The Proportion of progressive-free survival will be recorded.The disease progression criteria refer to the relevant provisions of the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guidelinefor PPF, including deterioration of respiratory symptoms, physiological evidence of disease progression, and radiological evidence.

  3. 6 Six Minute Walk Distance(6MWD)

    Time frame: Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.

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

  4. Pulse Oxygen Saturation（SPO2）

    Time frame: Change from baseline SPO2 at week 13, 26, 39, 52, 65, 78, 91 and 104.

    Before and after the 6-minute walk test, blood oxygen saturation (SPO2) will be detected through a pulse oximeter monitor.

  5. Traditional Chinese medicine syndromes

    Time frame: The traditional Chinese medicine syndromes at weeks 13, 26, 39, 52, 65, 78 ,91 and 104.s.

    The Traditional Chinese medicine syndromes will be recorded. The diagnosis of traditional Chinese medicine syndromes for IPF refers to the 2019 version of the diagnostic criteria for idiopathic pulmonary fibrosis, while PPF refers to the 2012 version of the diagnostic criteria for diffuse interstitial lung disease.

  6. Clinical symptoms and Signs

    Time frame: Change from baseline clinical symptoms and signs up at week 13, 26, 39, 52, 65, 78, 91 and 104 weeks.

    Clinical symptoms and Signs will be evaluated through a scale. The scale includes coughing, expectoration, chest tightness, shortness of breath, wheezin. The Clinical Symptom Rating Scale includes 6 items: cough, expectoration, chest tightness, shortness of breath, wheezing, and cyanosis. Each item has a score of 0-3, totaling 18 points. The higher the score, the worse he patient's condition.

  7. Pulmonary function

    Time frame: Change from baseline FVC, FVC%, DLco and DLco% at week 26, 52, 78 and 104.

    Forced vital capacity (FVC), FVC as the percentage of the predicted value（FVC%）, carbon monoxide diffusing capacity（DLco）and DLco as the percentage of the predicted value (DLco%) will be applied to assess pulmonary function.

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

    Time frame: Change from baseline SGRQ total scores at week 13, 26, 39, 52, 65, 78, 91 and 104.

    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.

  9. A Tool to Assess Quality of life in IPF(ATAQ-IPF) total scores

    Time frame: Change from baseline ATAQ-IPF total scores at week 13, 26, 39, 52, 65, 78, 91 and 104.

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

  10. Imaging findings

    Time frame: Change from baseline Imaging findings at week 13, 26, 39, 52, 65, 78, 91 and 104.

    The Imaging findings will be recorded by HRCT examination.

Study contacts

Contact information is provided by the study sponsor or research team.

Xue-qing Yu, Ph.D

CONTACT

[email protected]

+8613525518843

Sponsors and collaborators

Lead sponsor

Henan University of Traditional Chinese Medicine

Other

Registry information

Official study title

REspiratory diSEAse cohoRt Studies of CHinese Medicine for Interstitial Lung Disease (RESEARCH-ILD)

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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