Non-Cystic Fibrosis BronchiectasisPhase 2NCT06981091
A Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of XH-S004 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis
A Phase 2 study testing XH-S004 20 mg and XH-S004 40 mg in people with Non-Cystic Fibrosis Bronchiectasis, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to find out if XH-S004 can reduce pulmanary exacerbation over a 24-week treatment duration in participants with non-cystic fibrosis bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-Cystic Fibrosis Bronchiectasis
- What is being tested?
- XH-S004 20 mg and XH-S004 40 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2025to 28 Apr 2027
- Phase
- Phase 2
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand the procedures and methods of this trial and sign a written informed consent form;
- Male or female paticipants aged 18-85 years (inclusive) ;
- Chest HRCT shows bronchiectasis affecting one or more lobes, and the condition is clinically diagnosed as non-cystic fibrosis bronchiectasis (clinical manifestations include chronic cough, significant productive cough, and/or intermittent hemoptysis, with or without varying degrees of polypnoea and other symptoms);
- Based on medical history and the determination of the investigator , participants have at least 2 documented pulmonary exacerbations in the past 12 months before Screening;
- Are current sputum producers with a history of chronic expectoration and able to provide a spontaneous sputum sample at screening visit (as described by the patient) ;
- The body mass index (BMI) is ≥18 kg/m2 at screening;
- Participants must ensure and agree that from 28 days prior to signing the informed consent form to 28 days after the final administration, women of childbearing potential, male participants, and their partners will use effective contraception methods other than oral drugs (e.g., condoms or intra-uterine contraceptive devices) and will not donate sperm or eggs during this period
Who cannot join
- Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
- Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
- Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
- Have any acute infections, (including respiratory infections)
- Patients who have previously received therapy with DPP1 inhibitors of the same class
Trial locations and contacts
1 site in 1 country.
China1 site
Huadong Hospital Affiliated to fudan univercity
Shanghai, Shanghai Municipality, 200040
About this study
The purpose of this study is to find out if XH-S004 can reduce pulmanary exacerbation over a 24-week treatment duration in participants with non-cystic fibrosis bronchiectasis.
Read the detailed description
This study is a multicenter, double-blind, placebo-controlled, parallel-group study conducted in china, aimed at evaluating the efficacy, safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of XH-S004 administered once daily for 24 weeks in participants with non-cystic fibrosis bronchiectasis (NCFBE).
This study plans to enroll 231 patients with bronchiectasis. Patients who sign the informed consent form will be screened according to the enrollment criteria, and randomly divided into 3 groups. Participants in groups 1 and 2 will receive different doses of XH-S004. Participants in group 3 will receive placebo.
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Being tested
- XH-S004 20 mg, XH-S004 40 mg, Placebo
- Keywords
- Bronchiectasis, Active neutrophil elastase, Fibrosis
- Medical subject headings
- Bronchiectasis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XH-S004 20 mgOther
Administered once per day for 24 weeks.
XH-S004 40 mgOther
Administered once per day for 24 weeks.
PlaceboOther
Administered once per day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Participant Group | Experimental | Participants received XH-S004 20 mg once daily (QD) , for 24 weeks. Receives: Other: XH-S004 20 mg |
| Arm 2: Participant Group | Experimental | Participants received XH-S004 40 mg once daily (QD) , for 24 weeks. Receives: Other: XH-S004 40 mg |
| Arm 3: Participant Group | Placebo comparator | Participants received the matching placebo once daily (QD) , for 24 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period
Time to first pulmonary exacerbation was calculated as the number of days from the date of randomization to the date of first documentation of an exacerbation. Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics (EMBARC guideline) : 1. Increased cough 2. Increased sputum volume 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis.
Measured: Baseline (Day 1) to Week 24
Secondary outcomes (5)
Incidence of pulmonary exacerbation as defined by EMBARC over 24-week treatment period.
Time to first pulmonary exacerbation was calculated as the number of days from the date of randomization to the date of first documentation of an exacerbation. Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics (EMBARC guideline) : 1. Increased cough 2. Increased sputum volume 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis.
Measured: Baseline (Day 1) to Week 24
Incidence of Pulmonary exacerbation as defined by investigators over 24-week treatment period.
The definition of pulmonary exacerbation determined by investigator was defined as: Compared with previous symptoms, patient's current symptoms have worsened but not meet the EMBARC guideline-defined criteria for pulmonary exacerbation . However, the invetigator will have determined that oral/IV antibiotic therapy is required.
Measured: Baseline (Day 1) to Week 24
Change from baseline in forced expiratory volume in 1 second (FEV1) in pulmonary function test at week 24 after first drug administration.
FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after taking a deep breath.
Measured: At baseline and at week 24
Change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOLB) respiratory symptoms domain score at week 24 after first drug administration;
The QOL-B is a validated, self-administered patient reported outcome (PRO) that assesses symptoms, functioning, and health-related (HR) QOL for participants with non-cystic fibrosis bronchiectasis (NCFBE). The QOL-B contains 37 items in 8 domains (Respiratory Symptoms, Physical Functioning, Role Functioning, Emotional Functioning, Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each of the 37 items is scored from 1 to 4, and each of the 8 domains scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HR QoL. A positive change from Baseline indicates improvement in symptoms. For this outcome measure, change in the respiratory symptoms domain score from Baseline was reported.
Measured: At baseline and at week 24
Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum
The concentration of active NE in sputum, was measured by the difference between the pre-treatment concentration, on-treatment concentration and post-treatment concentration. In bronchiectasis, activation of neutrophils in the airway leads to release of NE which leads to damaged airway walls, mucus hypersecretion, exacerbated inflammation, which in turn affects neutrophil and macrophage functions, increasing the risk of infection. Negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start30 May 2025
- Primary completion8 Jan 2027 (estimated)
- Study completion28 Apr 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 BronchiectasisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981091
- Sponsor's protocol ID
- XH-S004-201
- Status last verified
- Sep 2026
- First submitted
- 12 May 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No