Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis

Bronchiectasis Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06393257
• Other study ID #: 20230901
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Jin-Fu Xu, PhD
• Phone: +8613321922898
• Email: jfxucn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: May 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis Adult

Intervention

Device:
• Oscillation and Lung Expansion
A novel airway clearance technology

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.

Drug:
• Anti-infective therapy
Antibiotics were used in these patients.
• Mucolytic
Mucolytics were used in these patients.

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai
China	Shanghai pulmonary hospital	Shanghai	Shanghai
China	The Shanghai First People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sputum volume in 24h		2 weeks
Secondary	Bronchiectasis exacerbation and symptom tool	BEST score	Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Secondary	Quality of life questionnaire-bronchiectasis	Qol-B score	Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Secondary	Leicester Cough Questionnaire	LCQ score	Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Secondary	Bronchiectasis Health Questionnaire	BHQ score	Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Secondary	Time to the first bronchiectasis exacerbation since randomization	Time to the first bronchiectasis exacerbation since randomization	Assessed at 4 weeks, 8 weeks and 12 weeks post-discharge