A Multicenter, Observational Study to Investigate Sputum Inflammation Phenotyping and Predict Clinical Outcomes in Non-Cystic Fibrosis Bronchiectasis, with Subsequent Participation in the HSK31858 Clinical Trial

Guangzhou Institute of Respiratory Disease1 site in 1 country400 target enrollmentDecember 1, 2024

ConditionsNon-cystic Fibrosis Bronchiectasis (NCFBE)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-cystic Fibrosis Bronchiectasis (NCFBE)
Sponsor: Guangzhou Institute of Respiratory Disease
Enrollment: 400
Locations: 1
Primary Endpoint: Frequency of pulmonary exacerbations
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an observational, multicenter study aimed at investigating the inflammation phenotypes in sputum samples from patients with non-cystic fibrosis bronchiectasis (NCFBE). The study will observe and classify these phenotypes during the clinical screening phase without any intervention. Patients enrolled in this study may later participate in the HSK31858 clinical trial, where they will receive treatment as part of the trial protocol. After the unblinding of the trial, the study will analyze the relationship between sputum inflammation phenotypes and clinical outcomes, including treatment response and prognosis. The goal is to develop a clinical prediction model that incorporates inflammation subtypes to better predict patient outcomes in bronchiectasis.

Registry

clinicaltrials.gov

Start Date

December 1, 2024

End Date

January 1, 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Guangzhou Institute of Respiratory Disease

Responsible Party

Principal Investigator

Weijie Guan

Deputy Director of the Clinical Research Center

Guangzhou Institute of Respiratory Disease

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years and BMI≥18.0 kg/m\^2 at the time of signing the ICF.
•Chest HRCT showed bronchiectasis affecting one or more lobes and was confirmed by a clinician as NCFBE(clinically characterized by chronic cough, expectoration and/or intermittent hemoptysis, with or without shortness of breath and respiratory failure). HRCT was considered effective if the patient had received HRCT in the same hospital within 12 months and screening HRCT is not necessary.
•Have at least 2 pulmonary exacerbations in the past 12 months before Screening.
•If long-term treatment with bronchodilators (long-acting β-agonists and/or long-acting muscarinic antagonists) is required, the dose and regimen should remain stable for at least 3 months before the screening visit and throughout the study period.
•The estimated survival time ≥ 12 months.
•Women must be post-menopausal, surgically sterile, or using highly effective contraception methods from Day 1 to at least 30 days after the last dose.
•Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
•Give their signed study informed consent to participate.

Exclusion Criteria

•Have a primary diagnosis of COPD or asthma as judged by the Investigator.
•A history of malignancy (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary carcinoma of the thyroid gland. The patients who had survived lung cancer surgery for at least 5 years without antitumor therapy can enroll in the study ) within 5 years prior to screening or a history of antitumor therapy.
•Have bronchiectasis due to CF (HRCT showed that the above lung diseases became predominant) as judged by the Investigator.
•Currently being treated Non-tuberculous Mycobacterial (NTM) pulmonary infections, allergic bronchopulmonary aspergillosis, or tuberculosis (TB), or active and currently symptomatic infections caused by COVID-19, or have the history of bronchopulmonary aspergillosis.
•Patients with severe pulmonary fibrosis such as lung destruction, pneumonectomy surgery history, and pneumoconiosis, as well as previous or existing decompensated stage of pulmonary heart disease.
•Patients who had experienced any degree of acute exacerbation of bronchiectasis or were developing an acute exacerbation of bronchiectasis before 4 weeks of screening.
•Patients who had hemoptysis and required medical intervention within 4 weeks prior to screening(except for coughing up minorbloody streaks).
•Patients previously treated with HSK31858 or other DPP1 inhibitor products.
•Subjects with uncontrolled hypertension (SBP ≥180 mmHg at rest and/or DBP ≥110 mmHg).
•Subjects with uncontrolled type 1 or type 2 diabetes (fasting plasma glucose \&gt;7.0 mmol/L).

Outcomes

Primary Outcomes

Frequency of pulmonary exacerbations

Time Frame: week 52

Secondary Outcomes

Time to first pulmonary exacerbation(week 52)
Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score(week 52)
Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire(week 52)