NCT03443531

Brief Summary

The aim of this study is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) on patients with clinically stable bronchiectasis by a multi-center, randomized, double-blind, controlled trial: one, TCM treatments based on syndrome differentiation; the other, a placebo of TCM treatment.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2018

Typical duration for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

2.5 years

First QC Date

January 26, 2018

Last Update Submit

February 17, 2018

Conditions

Bronchiectasis

Keywords

BronchiectasisTraditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

  • The frequency of bronchiectasis exacerbation

    The bronchiectasis exacerbations often result in reduced quality of life, increased rate of lung function decline, increased hospitalization. It is important to assess the changes of bronchiectasis exacerbations over time.

    Changes in the frequency of exacerbation at the week 12 and week 24 of the treatment phase, and at the week 24 of the follow-up phase compared with baseline.

Secondary Outcomes (2)

  • The time to the first bronchiectasis exacerbation

    Week 24 of the treatment phase.

  • Changes in Forced expiratory volume in one second

    Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline.

Other Outcomes (3)

  • Changes in St Georges respiratory questionnaire scores

    Changes in the SGRQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.

  • Changes in the Leicester Cough questionnaire scores

    Changes in the LCQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.

  • Changes in the Quality of Life-Bronchiectasis scores

    Changes in the Qol-B scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.

Study Arms (2)

TCM

EXPERIMENTAL

Patients in this group will receive two types of TCM treatment, which are Bufei Huatan granule, Yifei Qinghua granule. The herbal extract twice daily for 24 weeks for lower dosage. The two granules are corresponding to the two traditional Chinese syndromes in sequence, which are syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung, Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung.

Drug: Bufei Huatan granuleDrug: Yifei Qinghua granule

placebo TCM

PLACEBO COMPARATOR

Patients in this group will be given two placebo TCM treatment, which are which are placebo Bufei Huatan granule, placebo Yifei Qinghua granule, corresponding to the two traditional Chinese syndromes in sequence, which are syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung, Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung.

Drug: Placebo Bufei Huatan granuleDrug: Placebo Yifei Qinghua granule

Interventions

Bufei Huatan granuleDRUG

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung will be given Bufei Huatan granule, twice daily for 24 weeks for lower dosage.

TCM
Yifei Qinghua granuleDRUG

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung will be given Yifei Qinghua granule, twice daily for 24 weeks for lower dosage.

TCM
Placebo Bufei Huatan granuleDRUG

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung will be given placebo Bufei Huatan granule, twice daily for 24 weeks for lower dosage.

placebo TCM
Placebo Yifei Qinghua granuleDRUG

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung will be given placebo Yifei Qinghua granule, twice daily for 24 weeks for lower dosage.

placebo TCM

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A confirmed diagnosis of clinically stable bronchiectasis
  • Age between 18 and 80 years
  • Syndrome differentiation meets criteria of syndrome of Qi deficiency of lung and phlegm-turbidity obstructing the lung, syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung
  • Without participations in other interventional trials in the previous one month
  • With the informed consent signed

You may not qualify if:

  • Current respiratory disorders other than bronchiectasis (e.g. COPD,bronchial asthma, lung cancer,active tuberculosis, Interstitial lung disease, pulmonary thromboembolic, or Other patients who have an impact on the observation of disease)
  • Patients with severe cardiovascular disease (e.g. Acute myocardial infarction,Acute heart failure)
  • Severe liver disease(e.g.Active phase of hepatitis, Cirrhosis, Severe impairment of liver function by portal hypertension)
  • Severe renal disease(e.g. renal transplant, dialysis)
  • Patients with large hemoptysis in the last month
  • Pregnant and lactating women
  • Insanity, Dementia, and all kinds of Psychosis
  • Smoking patients (Years of smoking10/ package year)
  • Participating in other clinical trials with other interventions;
  • Allergic to the used medicine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Jiansheng Li, Doctor

    Henan University of Traditional Chinese Medicine

    STUDY CHAIR

Central Study Contacts

Zhiwan Wang, Doctor

CONTACT

86-0371-66248624zhiwan_w@163.com

Yang Xie, Doctor

CONTACT

86-0371-66248624xieyanghn@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 23, 2018

Study Start

March 1, 2018

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

February 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share