Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis

NCT06393257 | Recruiting DMC

• 1 other identifier: 20230901
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Bronchiectasis Adult

Keywords

bronchiectasis; Airway Clearance Technique

Outcome Measures

Primary Outcomes (1)

• sputum volume in 24h

  2 weeks

Secondary Outcomes (5)

• Bronchiectasis exacerbation and symptom tool

  Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge

• Quality of life questionnaire-bronchiectasis

  Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge

• Leicester Cough Questionnaire

  Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge

• Bronchiectasis Health Questionnaire

  Assessed at baseline, 2 weeks, 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

Study Arms (2)

Oscillation and Lung Expansion

EXPERIMENTAL

Device: Oscillation and Lung Expansion; Drug: Anti-infective therapy; Drug: Mucolytic

postural drainage

ACTIVE COMPARATOR

Behavioral: Postural drainage; Drug: Anti-infective therapy; Drug: Mucolytic

Interventions

Oscillation and Lung Expansion DEVICE

A novel airway clearance technology

Oscillation and Lung Expansion

Postural drainage BEHAVIORAL

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.

postural drainage

Anti-infective therapy DRUG

Antibiotics were used in these patients.

Oscillation and Lung Expansion; postural drainage

Mucolytic DRUG

Mucolytics were used in these patients.

Oscillation and Lung Expansion; postural drainage

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with acute exacerbation of bronchiectasis

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (3)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Shanghai pulmonary hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

The Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200433, China

NOT YET RECRUITING

Related Publications (7)

• Zhou YM, Wang C, Yao WZ, Chen P, Kang J, Huang SG, Chen BY, Wang CZ, Ni DT, Liu SM, Wang XP, Wang DL, Lu JC, Zheng JP, Zhong NS, Ran PX. [The prevalence and risk factors of bronchiectasis in residents aged 40 years old and above in seven cities in China]. Zhonghua Nei Ke Za Zhi. 2013 May;52(5):379-82. Chinese.

  PMID: 23945301 BACKGROUND

• Lin JL, Xu JF, Qu JM. Bronchiectasis in China. Ann Am Thorac Soc. 2016 May;13(5):609-16. doi: 10.1513/AnnalsATS.201511-740PS.

  PMID: 26882271 BACKGROUND

• Basavaraj A, Choate R, Addrizzo-Harris D, Aksamit TR, Barker A, Daley CL, Anne Daniels ML, Eden E, DiMango A, Fennelly K, Griffith DE, Johnson MM, Knowles MR, Metersky ML, Noone PG, O'Donnell AE, Olivier KN, Salathe MA, Schmid A, Thomashow B, Tino G, Winthrop KL. Airway Clearance Techniques in Bronchiectasis: Analysis From the United States Bronchiectasis and Non-TB Mycobacteria Research Registry. Chest. 2020 Oct;158(4):1376-1384. doi: 10.1016/j.chest.2020.06.050. Epub 2020 Jul 3.

  PMID: 32622820 BACKGROUND

• Munoz G, de Gracia J, Buxo M, Alvarez A, Vendrell M. Long-term benefits of airway clearance in bronchiectasis: a randomised placebo-controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701926. doi: 10.1183/13993003.01926-2017. Print 2018 Jan.

  PMID: 29326318 BACKGROUND

• Lee AL, Burge AT, Holland AE. Positive expiratory pressure therapy versus other airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev. 2017 Sep 27;9(9):CD011699. doi: 10.1002/14651858.CD011699.pub2.

  PMID: 28952156 BACKGROUND

• Liu Y, Lu HW, Gu SY, Wang WW, Ge J, Jie ZJ, Jia JG, Gao ZT, Li J, Shi JY, Liang S, Cheng KB, Bai JW, Qu JM, Xu JF. Bronchoscopic airway clearance therapy for acute exacerbations of bronchiectasis. EBioMedicine. 2021 Oct;72:103587. doi: 10.1016/j.ebiom.2021.103587. Epub 2021 Sep 16.

  PMID: 34537448 BACKGROUND

• Huynh TT, Liesching TN, Cereda M, Lei Y, Frazer MJ, Nahouraii MR, Diette GB. Efficacy of Oscillation and Lung Expansion in Reducing Postoperative Pulmonary Complication. J Am Coll Surg. 2019 Nov;229(5):458-466.e1. doi: 10.1016/j.jamcollsurg.2019.06.004. Epub 2019 Jul 27.

  PMID: 31362061 BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Interventions

Drainage, Postural; Expectorants

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Physical Therapy Modalities; Rehabilitation; Respiratory Therapy; Respiratory System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jin-Fu Xu, PhD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Fu Xu, PhD

CONTACT

+8613321922898; jfxucn@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized into one of the two groups. No cross-over of the study group will be made

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: May 1, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)