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BronchiectasisPhase 2NCT07523165

Efficacy and Safety of Lifei Qingchang Granules for Stable Bronchiectasis

A Phase 2 study testing Lifei Qingchang Granules and Postural Drainage in people with Bronchiectasis, run by The First Affiliated Hospital of Guangzhou Medical University at 3 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Lifei Qingchang Granules in the treatment of patients with stable bronchiectasis. This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bronchiectasis
What is being tested?
Lifei Qingchang Granules and Postural Drainage
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
3 sitesChina
Study dates
Apr 2026to Apr 2028
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 75 years old, regardless of sex.
  • Diagnosed with bronchiectasis confirmed by High-Resolution Computed Tomography (HRCT) scan.
  • Bronchiectasis is currently in the stable phase.
  • Experienced at least one acute exacerbation of bronchiectasis within the previous 12 months.
  • Diagnosed with the Traditional Chinese Medicine (TCM) syndrome of "Phlegm-Heat Obstructing the Lungs".
  • Able to understand the study protocol and voluntarily sign the informed consent form.

Who cannot join

  • Allergic to any ingredients of the investigational drug or placebo.
  • Comorbid with other severe systemic diseases (e.g., coronary heart disease, stroke, severe hypertension [systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg], active gastric ulcer, uncontrolled diabetes [fasting venous blood glucose ≥ 10 mmol/L], malignant tumors, abnormal liver or kidney function [AST, ALT, or GGT > 2 times the upper limit of normal; or serum creatinine > 2 times the upper limit of normal]) or psychiatric disorders.
  • Comorbid with asthma, allergic bronchopulmonary aspergillosis (ABPA), or active pulmonary tuberculosis.
  • Comorbid with chronic obstructive pulmonary disease (COPD) and presenting COPD as the primary clinical manifestation (as judged by the investigator).
  • Use of inhaled, oral, or intravenous antibiotics within 4 weeks prior to enrollment.
  • Type 2 respiratory failure requiring long-term non-invasive mechanical ventilation or oxygen therapy (> 10 hours/day).
Show all 11Show fewer
  • History of drug abuse, psychotropic drug dependence, or alcohol abuse.
  • Current smokers or those unable to stop smoking during the study.
  • Pregnant or lactating women, planning to become pregnant during the study, or refusing to use reliable contraceptive methods throughout the study period.
  • Participation in any other clinical trials within 3 months prior to enrollment.
  • Considered unsuitable for participation in this clinical study by the investigator.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China3 sites
  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510150

    Liping Wei, MD, 86-13650858667, weilp8@hotmail.com

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510170

    Zhimin Zhang, MD, 86-18928868345, zhangzhimin51666@163.com

    Ran Lin, MD, 86-18813751030, r2013051152@163.com

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

    Peng Pang, MD, 86-15099960366, pangpeng@gzhmu.edu.cn

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study on the Efficacy and Safety of Lifei Qingchang Granules for Stable Bronchiectasis

The purpose of this study is to evaluate the efficacy and safety of Lifei Qingchang Granules in the treatment of patients with stable bronchiectasis. This is a multicenter, randomized, double-blind, placebo-controlled clinical trial.

Researchers plan to enroll a total of 150 adult participants (aged 18-75) who have been diagnosed with stable bronchiectasis and experience at least one acute exacerbation in the past 12 months. Participants will be randomly assigned into two groups in a 1:1 ratio:

Read more
  • The treatment group will receive Lifei Qingchang Granules along with standard postural drainage therapy.
  • The control group will receive a matching placebo along with standard postural drainage therapy.

The treatment period will last for 3 months. The main goal is to see if the treatment can improve patients' respiratory symptoms and overall quality of life.

Read the detailed description

Bronchiectasis is characterized by pathological dilation of the bronchi, with main symptoms including chronic cough and expectoration. Currently, there is no specific cure, making it an urgent clinical problem. In Traditional Chinese Medicine (TCM), the pathogenesis of bronchiectasis is closely related to "phlegm-heat obstructing the lungs".

Lifei Qingchang Granule is an in-hospital preparation patented by the First Affiliated Hospital of Guangzhou Medical University (Patent No.: ZL202110246137.5, Guangdong Medical Preparation No. Z20240007001). Previous clinical observations suggest it effectively reduces acute exacerbations, decreases hemoptysis, and lowers hospitalization rates. This study aims to conduct a pre-clinical study for the transformation of this in-hospital preparation into a new drug.

This prospective, multicenter study plans to enroll 150 participants. Eligible participants must meet the diagnostic criteria for stable bronchiectasis, exhibit the TCM syndrome of "phlegm-heat obstructing the lungs," and have a history of at least one acute exacerbation in the previous 12 months.

Participants will be stratified based on their previous 12-month exacerbation frequency (<3 and ≥3 times) and randomized via an Interactive Web Response System (IWRS) into the herbal treatment group or the placebo group. Both groups will receive standardized postural drainage.

The primary efficacy endpoint is the change from baseline in the respiratory dimension score of the Quality of Life-Bronchiectasis questionnaire at month 3. Secondary endpoints include the St. George's Respiratory Questionnaire (SGRQ) score, 24-hour sputum volume, sputum characteristics (color and consistency), sputum bacteriology, TCM symptom scores, and pulmonary function tests (FVC, FEV1) at month 3. Safety assessments, including vital signs, laboratory tests, and adverse event monitoring, will be conducted throughout the study.

Conditions
Bronchiectasis
Being tested
Lifei Qingchang Granules, Placebo, Postural Drainage
Keywords
Stable Bronchiectasis, Traditional Chinese Medicine, Phlegm-Heat Syndrome, Lifei Qingchang Granules, Postural Drainage
Medical subject headings
Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifei Qingchang GranulesDrug

    A Traditional Chinese Medicine in-hospital preparation (Patent No.: ZL202110246137.5). Administered orally, 1 sachet per dose, 3 doses per day for 3 months.

  • PlaceboOther

    An inactive matching placebo primarily composed of dextrin, lactose, edible essence, and food coloring. Administered orally, 1 sachet per dose, 3 doses per day for 3 months.

  • Postural DrainageProcedure or surgery

    Standardized postural drainage therapy to assist in sputum clearance.

Study groups in NCT07523165
Study groupRoleWhat they receive
Experimental: Lifei Qingchang GranulesExperimentalParticipants in this arm will receive Lifei Qingchang Granules combined with postural drainage. The granules are administered orally, 1 sachet each time, 3 times a day , for a total duration of 3 months.
Receives: Drug: Lifei Qingchang Granules; Procedure: Postural Drainage
Placebo Comparator: PlaceboPlacebo comparatorParticipants in this arm will receive a matching placebo combined with postural drainage. The placebo is administered orally, 1 sachet each time, 3 times a day , for a total duration of 3 months.
Receives: Other: Placebo; Procedure: Postural Drainage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the Respiratory Domain Score of the Quality of Life-Bronchiectasis (QOL-B) Questionnaire

    The QOL-B questionnaire is utilized to assess the impact of bronchiectasis on daily life, specifically focusing on the respiratory domain which evaluates symptoms such as cough, sputum production, and shortness of breath.

    Measured: Baseline and Month 3 (Day 84)

Secondary outcomes (5)
  1. Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Score

    Measured: Baseline and Month 3 (Day 84)

  2. Change from Baseline in 24-hour Sputum Volume

    Measured: Baseline and Month 3 (Day 84)

  3. Change from Baseline in Pulmonary Function (FVC and FEV1)

    Measured: Baseline and Month 3 (Day 84)

  4. Change from Baseline in Sputum Characteristics (Color and Consistency) Score

    Measured: Baseline and Month 3 (Day 84)

  5. Change from Baseline in Traditional Chinese Medicine (TCM) Syndrome Score

    Measured: Baseline and Month 3 (Day 84)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionMar 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

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
Participants will be randomly assigned to either the experimental group (Lifei Qingchang Granules) or the placebo group in a 1:1 ratio. To ensure baseline balance between the two groups, the randomization is stratified based on the participants' frequency of acute exacerbations of bronchiectasis in the previous 12 months (\<3 times vs. ≥3 times). Throughout the study, participants in both arms will receive standardized postural drainage as a background therapy.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07523165
Sponsor's protocol ID
GMUCR2025-01009
Status last verified
Apr 2026
First submitted
4 Apr 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared publicly to strictly protect patient privacy and comply with the confidentiality agreement approved by the Ethics Committee. All electronic data are encrypted and stored on dedicated hospital servers. Only authorized parties, such as the Ethics Committee and regulatory authorities, have access to the original records under strict confidentiality protocols.

Publications

  • Yuanlong H, Wanyan L, Jiamin Z, Shangke G, Yingsi D, Ran L, Zhu L, Shiting D, Min H, Zhiming P, Qifen H, Zhijuan W, Xinghua S, Shouxie H, Zhenqiu L, Dapeng Z, Wenju L, Zhimin Z. Lifei Qingchang Granules alleviate airway inflammation in a mouse model of bronchiectasis by inhibiting neutrophil extracellular traps. J Ethnopharmacol. 2026 Feb 10;356:120855. doi: 10.1016/j.jep.2025.120855. Epub 2025 Nov 4.

    PubMed 41192693
  • Huang QF, Zeng JM, Hu YL, Li WY, Yu QH, Wang P, Ren PH, Peng Y, Guan WJ, Lin R, Li ZQ, Tan WL, Zhu HP, Huang SX, Zhang DP, Jie ZC, Wu ZJ, Zhang ZM. Lifei Qingchang Tang attenuates acute lung injury via the NF-kappaB and MAPK signaling pathways. J Asian Nat Prod Res. 2025 Nov;27(11):1690-1705. doi: 10.1080/10286020.2025.2473648. Epub 2025 Mar 12.

    PubMed 40072449
  • Zhang ZM, Ren PH, Wu ZJ, Zhang DP, Xie WJ. Personalized alternative therapy of intractable bronchiectasis-induced hemoptysis in a patient: syndrome differentiation and treatment according to individual physique category. J Thorac Dis. 2013 Jun;5(3):E115-7. doi: 10.3978/j.issn.2072-1439.2013.06.26. No abstract available.

    PubMed 23825784
  • Zhang ZM, Ren PH, Guan WJ. Symptom-based treatment with Traditional Chinese Medicine in bronchiectasis patients with hemoptysis. J Thorac Dis. 2017 Sep;9(9):E884-E886. doi: 10.21037/jtd.2017.08.170. No abstract available.

    PubMed 29221370

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lifei Qingchang Granules and Postural Drainage in people with Bronchiectasis, run by The First Affiliated Hospital of Guangzhou Medical University at 3 sites 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 6 inclusion and 11 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Zhimin Zhang, MD (86-18928868345, zhangzhimin51666@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the Respiratory Domain Score of the Quality of Life-Bronchiectasis (QOL-B) Questionnaire (time frame: Baseline and Month 3 (Day 84)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07523165, which also lists 4 linked publications.

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 13 Apr 2026.

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