Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis

April 27, 2024 updated by: Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

Efficacy and Safety of Airway Clearance Technique by Oscillation and Lung Expansion in Patients With Bronchiectasis

The goal of this prospective randomized controlled trial is to explore the efficacy and safety of Oscillation and Lung Expansion-a airway clearance technology-in bronchiectasis. Participants will receive Oscillation and Lung Expansion or postural drainage randomly in this study. and the symptom, quality of life scores and amount of expectoration will be compared between the two groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jin-Fu Xu, PhD
  • Phone Number: +8613321922898
  • Email: jfxucn@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Ruijin Hospital
        • Contact:
          • Jie-ming Qu, PhD
        • Principal Investigator:
          • Jie-ming Qu
      • Shanghai, Shanghai, China, 200433
        • Not yet recruiting
        • The Shanghai First People's Hospital
        • Contact:
          • Min Zhang, MD
        • Principal Investigator:
          • Min Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with acute exacerbation of bronchiectasis

Exclusion Criteria:

  • Haemoptysis greater than 50ml
  • state of endangerment
  • pneumothorax
  • Lung surgery history within 6 months
  • Severe heart, brain and nervous system diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oscillation and Lung Expansion
Device: Oscillation and Lung Expansion
A novel airway clearance technology
Drug: Anti-infective therapy
Antibiotics were used in these patients.
Drug: Mucolytic
Mucolytics were used in these patients.
Active Comparator: postural drainage
Drug: Anti-infective therapy
Antibiotics were used in these patients.
Drug: Mucolytic
Mucolytics were used in these patients.
Behavioral: Postural drainage
A type of physical therapy used to treat respiratory diseases by changing the patient's body position so that sputum is drained down the respiratory tract so that it can be more easily expelled from the body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sputum volume in 24h
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bronchiectasis exacerbation and symptom tool
Time Frame: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
BEST score
Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Quality of life questionnaire-bronchiectasis
Time Frame: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Qol-B score
Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Leicester Cough Questionnaire
Time Frame: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
LCQ score
Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Bronchiectasis Health Questionnaire
Time Frame: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
BHQ score
Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Time to the first bronchiectasis exacerbation since randomization
Time Frame: Assessed at 4 weeks, 8 weeks and 12 weeks post-discharge
Time to the first bronchiectasis exacerbation since randomization
Assessed at 4 weeks, 8 weeks and 12 weeks post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Investigators

  • Principal Investigator: Jin-Fu Xu, PhD, Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 21, 2024

First Submitted That Met QC Criteria

April 27, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 27, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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