Bronchiectasis AdultNCT03643302
Airway Clearance and Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation
An observational study of Bronchiectasis Adult, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
No study have evaluated the efficacy and safety of airway clearance therapy (ACT) and bronchoalveolar lavage (BAL) under bronchoscope for bronchiectasis. This study aimed to evaluate the clinical efficacy and safety of tran-bronchoscopy airway clearance and bronchoalveolar lavage in the treatment of moderate to severe… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- Version BF-1T26 electronic bronchoscope
- Type of treatment
- Medical device
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 18 Mar 2019
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bronchiectasis being suffering an acute exacerbation of this disease.
Who may be able to join
- Willing to join in and sign the informed consent form;
- The diagnosis of bronchiectasis need reference to the definition of "European Respiratory Society guidelines for the management of adult bronchiectasis." published by the european respiratory journal in 2017, defined by the presence of both permanent bronchial dilatation on computed tomography (CT) scanning and the clinical syndrome of cough, sputum production and/or recurrent respiratory infections;
- Pulmonary exacerbation in patients with bronchiectasis was required to meet three or more of the following key symptoms for at least 48h: Cough; Sputum volume and/or consistency; Sputum purulence; Breathlessness and/or exercise tolerance; Fatigue and/or malaise; Haemoptysis, and a clinician determines that a change in bronchiectasis treatment is required;
- According to the researchers, the subjects were willing and able to follow the protocol and were able to tolerate bronchoscopy;
- Patients with good compliance: the subject must be willing to follow the test plan requirements in the research center to complete all the assessment of the visit.
Who cannot join
- Pregnant or lactating women;
- Hypogammaglobulinemia or other autoimmune diseases;
- Clinical diagnosis of ABPA;
- Non tuberculosis mycobacteria positive 2 years before;
- Allergies or allergic to a variety of drugs;
- Poor compliance or can not cooperate judged by doctors;
Show all 12Show fewer
- Participated in other clinical trials for nearly three months;
- The researchers considered that the subject had other circumstances that were unfit to attend;
- Suffering from a significant disease or condition outside of bronchiectasis, as judged by the researchers, may lead to subjects at risk due to participate in the study,or the disease that have an impact on the research result and the ability of subjects to participate in this study;
- Bronchoscopy contraindication;
- Patients with heart, liver and kidney, nervous system, endocrine and other systemic diseases, may not be able to adhere to the completion of the study, or will affect the research process;
- Patients who refused to sign informed consent after targeted explanation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy and Safety of Tran-bronchoscopy Airway Clearance and Bronchoalveolar Lavage in the Treatment of Moderate to Severe Bronchiectasis With Acute Exacerbation
No study have evaluated the efficacy and safety of airway clearance therapy (ACT) and bronchoalveolar lavage (BAL) under bronchoscope for bronchiectasis.
This study aimed to evaluate the clinical efficacy and safety of tran-bronchoscopy airway clearance and bronchoalveolar lavage in the treatment of moderate to severe bronchiectasis with acute exacerbation:A randomized, prospective cohort study.
Read the detailed description
The aim of this study was to evaluate the efficacy and safety of ACT combined with BAL for bronchiectasis patients with acute exacerbation through the whole study process, which will provide a high quality of evidence-based strategies for the treatment, revision and optimization of international and domestic clinical guidelines for bronchiectasis. All the participants will be required to check the various efficacy and safety indicators.
- Conditions
- Bronchiectasis Adult
- Being tested
- Version BF-1T26 electronic bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Version BF-1T26 electronic bronchoscopeDevice
Interventions involving the therapy of airway clearance and bronchoalveolar lavage by Version BF-1T26 electronic bronchoscope
| Study group | Role | What they receive |
|---|---|---|
| Therapy of bronchoalveolar lavage group | Patients with bronchiectasis exacerbations treat with fundamental treatment combining with the therapy of airway clearance and bronchoalveolar lavage. Receives: Device: Version BF-1T26 electronic bronchoscope | |
| Fundamental treatment group | In the control group,fundamental treatment was adopted according to the guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first acute exacerbation after treatment
The median time to first acute exacerbation after discharge.We used GraphPad Prism 6.0 Kaplan-Meier survival curve and the log-rank test to compare the differences of the primary outcome between both groups
Measured: 3 month
Secondary outcomes (5)
The changes of mMRC score before and after treatment
Modified Medical Research Centre
Measured: 7 days
The changes of CAT score before and after treatment
COPD Assessment Test
Measured: 7 days
The changes of SGRQ before and after treatment
St. George respiratory questionnaire
Measured: 7 days
The changes of LCQ before and after treatment
Leicester Cough Questionnaire
Measured: 7days
The changes of 6MWD before and after treatment
6 Minute Walking Distance
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Feb 2018
- Primary completion28 Feb 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
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, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643302
- Sponsor's protocol ID
- 20180717
- Status last verified
- Oct 2020
- First submitted
- 21 Aug 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McDonnell MJ, Aliberti S, Goeminne PC, Dimakou K, Zucchetti SC, Davidson J, Ward C, Laffey JG, Finch S, Pesci A, Dupont LJ, Fardon TC, Skrbic D, Obradovic D, Cowman S, Loebinger MR, Rutherford RM, De Soyza A, Chalmers JD. Multidimensional severity assessment in bronchiectasis: an analysis of seven European cohorts. Thorax. 2016 Dec;71(12):1110-1118. doi: 10.1136/thoraxjnl-2016-208481. Epub 2016 Aug 11.
PubMed 27516225Hill AT, Haworth CS, Aliberti S, Barker A, Blasi F, Boersma W, Chalmers JD, De Soyza A, Dimakou K, Elborn JS, Feldman C, Flume P, Goeminne PC, Loebinger MR, Menendez R, Morgan L, Murris M, Polverino E, Quittner A, Ringshausen FC, Tino G, Torres A, Vendrell M, Welte T, Wilson R, Wong C, O'Donnell A, Aksamit T; EMBARC/BRR definitions working group. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017 Jun 8;49(6):1700051. doi: 10.1183/13993003.00051-2017. Print 2017 Jun.
PubMed 28596426Liu 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 34537448
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Tran-bronchoscopy Airway Clearance and Bronchoalveolar Lavage in the Treatment of Moderate to Severe Bronchiectasis With Acute Exacerbation
- ClinicalTrials.gov ID
- NCT03643302
- Acronym / sponsor ID
- 20180717
- Conditions
- Bronchiectasis Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 22 Aug 2018 (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.
No study have evaluated the efficacy and safety of airway clearance therapy (ACT) and bronchoalveolar lavage (BAL) under bronchoscope for bronchiectasis.
This study aimed to evaluate the clinical efficacy and safety of tran-bronchoscopy airway clearance and bronchoalveolar lavage in the treatment of moderate to severe bronchiectasis with acute exacerbation:A randomized, prospective cohort study.
Detailed description
The aim of this study was to evaluate the efficacy and safety of ACT combined with BAL for bronchiectasis patients with acute exacerbation through the whole study process, which will provide a high quality of evidence-based strategies for the treatment, revision and optimization of international and domestic clinical guidelines for bronchiectasis. All the participants will be required to check the various efficacy and safety indicators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy of bronchoalveolar lavage group | – | Device: Version BF-1T26 electronic bronchoscopePatients with bronchiectasis exacerbations treat with fundamental treatment combining with the therapy of airway clearance and bronchoalveolar lavage. |
| Fundamental treatment group | – | –In the control group,fundamental treatment was adopted according to the guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bronchiectasis being suffering an acute exacerbation of this disease.
Key inclusion criteria (5 listed)
- Willing to join in and sign the informed consent form;
- The diagnosis of bronchiectasis need reference to the definition of "European Respiratory Society guidelines for the management of adult bronchiectasis." published by the european respiratory journal in 2017, defined by the presence of both permanent bronchial dilatation on computed tomography (CT) scanning and the clinical syndrome of cough, sputum production and/or recurrent respiratory infections;
- Pulmonary exacerbation in patients with bronchiectasis was required to meet three or more of the following key symptoms for at least 48h: Cough; Sputum volume and/or consistency; Sputum purulence; Breathlessness and/or exercise tolerance; Fatigue and/or malaise; Haemoptysis, and a clinician determines that a change in bronchiectasis treatment is required;
- According to the researchers, the subjects were willing and able to follow the protocol and were able to tolerate bronchoscopy;
- Patients with good compliance: the subject must be willing to follow the test plan requirements in the research center to complete all the assessment of the visit.
Key exclusion criteria (12 listed)
- Pregnant or lactating women;
- Hypogammaglobulinemia or other autoimmune diseases;
- Clinical diagnosis of ABPA;
- Non tuberculosis mycobacteria positive 2 years before;
- Allergies or allergic to a variety of drugs;
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 |
|---|---|---|
| Version BF-1T26 electronic bronchoscopeInterventions involving the therapy of airway clearance and bronchoalveolar lavage by Version BF-1T26 electronic bronchoscope | Device | Therapy of bronchoalveolar lavage group |
Primary outcome
Time to the first acute exacerbation after treatment
Time frame: 3 month
The median time to first acute exacerbation after discharge.We used GraphPad Prism 6.0 Kaplan-Meier survival curve and the log-rank test to compare the differences of the primary outcome between both groups
5 secondary outcomes
The changes of mMRC score before and after treatment
Time frame: 7 days
The changes of CAT score before and after treatment
Time frame: 7 days
The changes of SGRQ before and after treatment
Time frame: 7 days
The changes of LCQ before and after treatment
Time frame: 7days
The changes of 6MWD before and after treatment
Time frame: 1 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 27516225McDonnell MJ, Aliberti S, Goeminne PC, Dimakou K, Zucchetti SC, Davidson J, Ward C, Laffey JG, Finch S, Pesci A, Dupont LJ, Fardon TC, Skrbic D, Obradovic D, Cowman S, Loebinger MR, Rutherford RM, De Soyza A, Chalmers JD. Multidimensional severity assessment in bronchiectasis: an analysis of seven European cohorts. Thorax. 2016 Dec;71(12):1110-1118. doi: 10.1136/thoraxjnl-2016-208481. Epub 2016 Aug 11.
- Background: PubMed 28596426Hill AT, Haworth CS, Aliberti S, Barker A, Blasi F, Boersma W, Chalmers JD, De Soyza A, Dimakou K, Elborn JS, Feldman C, Flume P, Goeminne PC, Loebinger MR, Menendez R, Morgan L, Murris M, Polverino E, Quittner A, Ringshausen FC, Tino G, Torres A, Vendrell M, Welte T, Wilson R, Wong C, O'Donnell A, Aksamit T; EMBARC/BRR definitions working group. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017 Jun 8;49(6):1700051. doi: 10.1183/13993003.00051-2017. Print 2017 Jun.
- Derived from this study: 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.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis Adult, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the first acute exacerbation after treatment (time frame: 3 month). 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 NCT03643302, which also lists 3 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 8 Oct 2020.