Non-cystic Fibrosis Bronchiectasis (NCFBE)NCT06715956
Observational Study of Sputum Inflammation Phenotypes and Clinical Outcomes in Non-Cystic Fibrosis Bronchiectasis
An observational study of Non-cystic Fibrosis Bronchiectasis (NCFBE), run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis (NCFBE)
- What is being tested?
- Observational Cohort Classification of Inflammatory Subtypes in Bronchiectasis
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Jan 2027
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants aged 18 years and older with a confirmed diagnosis of non-cystic fibrosis bronchiectasis (NCFBE).
Who may be able to join
- 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.
Who cannot join
- 1. Have a primary diagnosis of COPD or asthma as judged by the Investigator. 2. 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.
- 3. Have bronchiectasis due to CF (HRCT showed that the above lung diseases became predominant) as judged by the Investigator.
- 4. 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.
- 5. 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.
- 6. Patients who had experienced any degree of acute exacerbation of bronchiectasis or were developing an acute exacerbation of bronchiectasis before 4 weeks of screening.
- 7. Patients who had hemoptysis and required medical intervention within 4 weeks prior to screening(except for coughing up minorbloody streaks).
Show all 17Show fewer
- 8. Patients previously treated with HSK31858 or other DPP1 inhibitor products. 9. Subjects with uncontrolled hypertension (SBP ≥180 mmHg at rest and/or DBP ≥110 mmHg).
- 10. Subjects with uncontrolled type 1 or type 2 diabetes (fasting plasma glucose \>7.0 mmol/L).
- 11. Subjects with a history of liver disease or current treatment for liver disease during the screening period, including but not limited to acute or chronic hepatitis, cirrhosis or liver failure (except for mild to moderate non-alcoholic fatty liver disease).
- 12. Active hepatitis B virus infection (hepatitis B surface antigen positive with HBV-DNA load above the lower limit of detection), active hepatitis C virus infection (HCV antibody positive with HCV-RNA load above the lower limit of detection), or known HIV infection or syphilis infection.
- 13. Any other unstable clinical condition, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, or major physiological dysfunction, that the investigator considers to be (a) likely to affect patient safety throughout the study; (b) Influence the results of the study and its interpretation; (c) impeding the patient\'s ability to complete the entire study.
- 14. Laboratory tests during the screening period meet the following conditions: AST>2.0×ULN or ALT>2.0×ULN or TBIL>1.5×ULN eGFR\<60ml/min/1.73m2 Hb<90 g/L WBC <3×109 /L PLT <70×109 /L INR>1.5ULN，PT>ULN+3s, or APTT>ULN+10s. 15. Had participated in a clinical trial of any other drug or medical device in the 3 months prior to the screening (a drug or medical device treated with a clinical trial) or the subject had not been more than 5 half-lives from the last clinical trial of the drug at the time of screening.
- 16. Medications that may cause hyperkeratosis (e.g., tumor necrosis factor-α antagonists) within 4 weeks prior to screening.
- 17. Patients who have used a strong inducer or suppressor of CYP3A within 14 days or 5 half-lives of the first investigational drug (whichever is longer).
- 18. Patients who had smoked an average of 10 cigarettes or more per day in the previous 1 year were screened.
- 19. Pregnancy and lactation. 20. The subjects were unable to complete the questionnaires due to their limited educational level, or the subjects and their families failed to fill in the subjects\' log cards.
- 21. Had received live attenuated vaccine within 30 days before randomization. 22. The investigators judged that there were other conditions that were not suitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Guan Wei Jie, 86-13826042052, battery203@163.com
About this study
Official title: 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
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.
- Being tested
- Observational Cohort Classification of Inflammatory Subtypes in Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Cohort Classification of Inflammatory Subtypes in BronchiectasisOther
This observational study classifies patients with non-cystic fibrosis bronchiectasis into inflammatory subtypes based on sputum analysis. No active treatment or intervention is administered during this observational phase. Participants will later be considered for treatment with HSK31858 as part of an independent clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Subtype A | Participants classified under this inflammatory subtype based on sputum analysis will be observed without any intervention during the observational phase. Receives: Other: Observational Cohort Classification of Inflammatory Subtypes in Bronchiectasis | |
| Inflammatory Subtype B | Participants classified under this inflammatory subtype based on sputum analysis will be observed without any intervention during the observational phase. Receives: Other: Observational Cohort Classification of Inflammatory Subtypes in Bronchiectasis | |
| Inflammatory Subtype C | Participants classified under this inflammatory subtype based on sputum analysis will be observed without any intervention during the observational phase. Receives: Other: Observational Cohort Classification of Inflammatory Subtypes in Bronchiectasis | |
| Inflammatory Subtype D | Participants classified under this inflammatory subtype based on sputum analysis will be observed without any intervention during the observational phase. Receives: Other: Observational Cohort Classification of Inflammatory Subtypes in Bronchiectasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of pulmonary exacerbations
Measured: week 52
Secondary outcomes (3)
Time to first pulmonary exacerbation
Measured: week 52
Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score
score from 0 to 8
Measured: week 52
Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire
score from 0 to 100
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis Bronchiectasis (NCFBE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijie Guan, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715956
- Sponsor's protocol ID
- HSK31858IIT
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06715956
- Acronym / sponsor ID
- HSK31858IIT
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Subtype A | – | Other: Observational Cohort Classification of Inflammatory Subtypes in BronchiectasisParticipants classified under this inflammatory subtype based on sputum analysis will be observed without any intervention during the observational phase. |
| Inflammatory Subtype B | – | Other: Observational Cohort Classification of Inflammatory Subtypes in BronchiectasisParticipants classified under this inflammatory subtype based on sputum analysis will be observed without any intervention during the observational phase. |
| Inflammatory Subtype C | – | Other: Observational Cohort Classification of Inflammatory Subtypes in BronchiectasisParticipants classified under this inflammatory subtype based on sputum analysis will be observed without any intervention during the observational phase. |
| Inflammatory Subtype D | – | Other: Observational Cohort Classification of Inflammatory Subtypes in BronchiectasisParticipants classified under this inflammatory subtype based on sputum analysis will be observed without any intervention during the observational phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants aged 18 years and older with a confirmed diagnosis of non-cystic fibrosis bronchiectasis (NCFBE).
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 1. Have a primary diagnosis of COPD or asthma as judged by the Investigator. 2. 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.
- 3. Have bronchiectasis due to CF (HRCT showed that the above lung diseases became predominant) as judged by the Investigator.
- 4. 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.
- 5. 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.
- 6. Patients who had experienced any degree of acute exacerbation of bronchiectasis or were developing an acute exacerbation of bronchiectasis before 4 weeks of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Cohort Classification of Inflammatory Subtypes in BronchiectasisThis observational study classifies patients with non-cystic fibrosis bronchiectasis into inflammatory subtypes based on sputum analysis. No active treatment or intervention is administered during this observational phase. Participants will later be considered for treatment with HSK31858 as part of an independent clinical trial. | Other | Inflammatory Subtype A, Inflammatory Subtype B, Inflammatory Subtype C, Inflammatory Subtype D |
Primary outcome
Frequency of pulmonary exacerbations
Time frame: week 52
3 secondary outcomes
Time to first pulmonary exacerbation
Time frame: week 52
Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score
Time frame: week 52
Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire
Time frame: week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingPhase 1
Phase 1 Study to Assess the Effects of HSK31858 on the QT/QTc Interval in Healthy Chinese Participants
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-cystic Fibrosis Bronchiectasis (NCFBE), run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guan Wei Jie (86-13826042052, battery203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of pulmonary exacerbations (time frame: week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.