Clinical trial NCT06393257: Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis
Official title: Efficacy and Safety of Airway Clearance Technique by Oscillation and Lung Expansion in Patients With Bronchiectasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchiectasis Adult
Keywords: bronchiectasis
Airway Clearance Technique
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into one of the two groups. No cross-over of the study group will be made
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: sputum volume in 24h
timeFrame: 2 weeks
Secondary outcomes:
measure: Bronchiectasis exacerbation and symptom tool
timeFrame: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
measure: Quality of life questionnaire-bronchiectasis
timeFrame: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
measure: Leicester Cough Questionnaire
timeFrame: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
measure: Bronchiectasis Health Questionnaire
timeFrame: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
measure: Time to the first bronchiectasis exacerbation since randomization
timeFrame: Assessed at 4 weeks, 8 weeks and 12 weeks post-discharge
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai pulmonary hospital
state: Shanghai
city: Shanghai
country: China
facility: The Shanghai First People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Jin-Fu Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.
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.