Bronchiectasis AdultNCT06393257
Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis
A study testing Oscillation and Lung Expansion, Postural drainage and Anti-infective therapy in people with Bronchiectasis Adult, run by Shanghai Pulmonary Hospital, Shanghai, China at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- Oscillation and Lung Expansion, Postural drainage and Anti-infective therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2023to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with acute exacerbation of bronchiectasis
Who cannot join
- Haemoptysis greater than 50ml
- state of endangerment
- pneumothorax
- Lung surgery history within 6 months
- Severe heart, brain and nervous system diseases
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200433
Jie-ming Qu, PhD
Jie-ming Qu
- Recruiting
Shanghai pulmonary hospital
Shanghai, Shanghai Municipality, 200433
Jin-Fu Xu, PhD, +8613321922898, jfxucn@163.com
- Not yet recruiting
The Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200433
Min Zhang, MD
Min Zhang, MD
About this study
Official title: 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.
- Conditions
- Bronchiectasis Adult
- Being tested
- Oscillation and Lung Expansion, Postural drainage, Anti-infective therapy, Mucolytic
- Keywords
- bronchiectasis, Airway Clearance Technique
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillation and Lung ExpansionDevice
A novel airway clearance technology
Postural drainageBehavioural
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.
Anti-infective therapyDrug
Antibiotics were used in these patients.
MucolyticDrug
Mucolytics were used in these patients.
| Study group | Role | What they receive |
|---|---|---|
| Oscillation and Lung Expansion | Experimental | Not described Receives: Device: Oscillation and Lung Expansion; Drug: Anti-infective therapy; Drug: Mucolytic |
| postural drainage | Active comparator | Not described Receives: Behavioral: Postural drainage; Drug: Anti-infective therapy; Drug: Mucolytic |
What is being measured
The primary outcome is the main question the study is designed to answer.
sputum volume in 24h
Measured: 2 weeks
Secondary outcomes (5)
Bronchiectasis exacerbation and symptom tool
BEST score
Measured: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Quality of life questionnaire-bronchiectasis
Qol-B score
Measured: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Leicester Cough Questionnaire
LCQ score
Measured: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Bronchiectasis Health Questionnaire
BHQ score
Measured: Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge
Time to the first bronchiectasis exacerbation since randomization
Time to the first bronchiectasis exacerbation since randomization
Measured: Assessed at 4 weeks, 8 weeks and 12 weeks post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into one of the two groups. No cross-over of the study group will be made
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Jin-Fu Xu, PhD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393257
- Sponsor's protocol ID
- 20230901
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23945301Lin JL, Xu JF, Qu JM. Bronchiectasis in China. Ann Am Thorac Soc. 2016 May;13(5):609-16. doi: 10.1513/AnnalsATS.201511-740PS.
PubMed 26882271Basavaraj 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.
PubMed 32622820Munoz 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.
PubMed 29326318Lee 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.
PubMed 28952156Liu 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.
PubMed 34537448Huynh 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.
PubMed 31362061
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Airway Clearance Technique by Oscillation and Lung Expansion in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT06393257
- Acronym / sponsor ID
- 20230901
- Conditions
- Bronchiectasis Adult
- Keywords
- bronchiectasis, Airway Clearance Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized into one of the two groups. No cross-over of the study group will be made
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with acute exacerbation of bronchiectasis
Key exclusion criteria (5 listed)
- Haemoptysis greater than 50ml
- state of endangerment
- pneumothorax
- Lung surgery history within 6 months
- Severe heart, brain and nervous system diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oscillation and Lung ExpansionA novel airway clearance technology | Device | Oscillation and Lung Expansion |
| Postural drainageA 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. | Behavioural | postural drainage |
| Anti-infective therapyAntibiotics were used in these patients. | Drug | Oscillation and Lung Expansion, postural drainage |
| MucolyticMucolytics were used in these patients. | Drug | Oscillation and Lung Expansion, postural drainage |
Primary outcome
sputum volume in 24h
Time frame: 2 weeks
5 secondary outcomes
Bronchiectasis exacerbation and symptom tool
Time frame: 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
Leicester Cough Questionnaire
Time frame: 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
Time to the first bronchiectasis exacerbation since randomization
Time frame: Assessed at 4 weeks, 8 weeks and 12 weeks post-discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 23945301Zhou 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.
- Background: PubMed 26882271Lin JL, Xu JF, Qu JM. Bronchiectasis in China. Ann Am Thorac Soc. 2016 May;13(5):609-16. doi: 10.1513/AnnalsATS.201511-740PS.
- Background: PubMed 32622820Basavaraj 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.
- Background: PubMed 29326318Munoz 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.
- Background: PubMed 28952156Lee 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.
- Background: PubMed 34537448Liu 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.
- Background: PubMed 31362061Huynh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Fu Xu, PhD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oscillation and Lung Expansion, Postural drainage and Anti-infective therapy in people with Bronchiectasis Adult, run by Shanghai Pulmonary Hospital, Shanghai, China at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Fu Xu, PhD (+8613321922898, jfxucn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sputum volume in 24h (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06393257, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.