Bronchiectasis with Acute ExacerbationNCT06726356
Value of Bronchoalveolar Lavage with Acetylcysteine in the Treatment of Bronchiectasis.
A study testing Bronchoalveolar Lavage in people with Bronchiectasis with Acute Exacerbation, run by First Affiliated Hospital of Ningbo University at 1 site in China.
Trial summary
Bronchiectasis is a clinical syndrome characterised by chronic cough, profuse sputum and/or intermittent haemoptysis, with or without shortness of breath and respiratory failure of varying severity, and abnormal thickening and dilatation of the bronchial walls as seen on lung imaging. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis with Acute Exacerbation
- What is being tested?
- Bronchoalveolar Lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2024to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥18 years and ≤80 years;
- Chest CT suggestive of bronchiectasis;
- meet the criteria for an acute exacerbation of bronchiectasis with symptoms such as cough, sputum, chest tightness or wheezing, and c. Patients who meet the criteria for an acute exacerbation of bronchiectasis with symptoms of cough, sputum, chest tightness or wheezing and who consent to bronchoscopy with bronchoalveolar lavage
- patients who agreed to participate in the study and signed an informed consent form;
Who cannot join
- Severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, psychiatric disorders or severe neuroses that are contraindications to bronchoscopy;
- Intraoperative findings of decreased SPO2 or inability to tolerate bronchoscopy or inability to tolerate further bronchoalveolar lavage;
- Inability to co-operate with the study for any reason or in the opinion of the investigator, inappropriate for inclusion in the study for other reasons;
- Bronchoscopy of patients with significant intra-airway haemorrhage who may be at risk of exacerbation due to bronchoalveolar lavage;
- Patients with acetylcysteine allergy;
- Missing information;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
Zhongbo Chen, 13777125910, leonczb@163.com
About this study
Official title: Efficacy and Safety of Bronchoalveolar Lavage with Acetylcysteine in the Treatment of Bronchiectasis with Infection in Adults: a Multicentre, Blinded, Randomised Controlled Study.
Bronchiectasis is a clinical syndrome characterised by chronic cough, profuse sputum and/or intermittent haemoptysis, with or without shortness of breath and respiratory failure of varying severity, and abnormal thickening and dilatation of the bronchial walls as seen on lung imaging. Nebulised inhalation of N-acetylcysteine has been shown to significantly improve symptoms, shorten the length of hospital stay, reduce the rate of re-hospitalisation within six months, and improve lung function in patients with bronchiectasis with a high degree of safety. There have been no studies on the efficacy and safety of bronchoscopic irrigation with N-acetylcysteine solution in the treatment of bronchiectasis. The aim of this study was to investigate whether bronchoscopic acetylcysteine lavage combined with conventional treatment is more beneficial to patients with bronchiectasis than conventional treatment combined with conventional bronchoalveolar lavage and conventional treatment without bronchoscopy, respectively.
Read the detailed description
All patients enrolled were patients with acute exacerbation of bronchiectasis. A total of 180 patients (1:1:1 allocation) with acute exacerbation of bronchiectasis were to be enrolled. The patients were divided into control group A (conventional clinical treatment including anti-infective and expectorant therapy), control group B (bronchoalveolar lavage with saline on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml), and experimental group C (bronchoalveolar lavage with acetylcysteine solution in combination with saline on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml).
- Conditions
- Bronchiectasis with Acute Exacerbation
- Being tested
- Bronchoalveolar Lavage
- Keywords
- bronchiectasis; acetylcysteine; bronchoalveolar lavage; Bronchoscopic airway clearance therapy
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar LavageProcedure or surgery
Bronchoalveolar lavage with saline or saline-acetylcysteine solution on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | based on conventional clinical treatment including anti-infective and expectorant therapy. |
| Group B | Other | Bronchoalveolar lavage with saline on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml. Receives: Procedure: Bronchoalveolar Lavage |
| Group C | Experimental | Bronchoalveolar lavage with acetylcysteine solution in combination with saline on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml. Receives: Procedure: Bronchoalveolar Lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of first and second acute exacerbation
Description: Length of post-treatment time points to first acute exacerbation (days) and length of time points to second acute exacerbation (days) in all three groups of patients.
Measured: six months
Secondary outcomes (7)
The change of mMRC scores
The modified Medical Research Council (mMRC) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). Categorised on a scale of 0 to 4, the higher the scale the more severe the symptoms are.
Measured: one month
The change of CAT scores.
COPD assessment test (CAT) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). A score of 0-10 is considered mild, 11-20 is considered moderate, 21-30 is considered severe, and 31-40 is considered very severe.
Measured: one month
The change of LCQ scores.
Leicester Cough Questionnaire (LCQ) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). Scores range from 3 to 21, with lower scores suggesting that cough has a greater impact on quality of life.
Measured: one month
The change of SGQR scores.
St George's Respiratory Questionnaire (SGRQ) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). The total score ranges from 0 to 100. Higher scores indicate poorer quality of life for the patient.
Measured: one month
Number of acute exacerbations
Number of acute exacerbations in the three groups at 6 months after treatment.
Measured: six months
adverse effects
Occurrence of post-treatment adverse effects (chest tightness, shortness of breath, worsening of respiratory failure, worsening of haemoptysis, complication of new pneumonia foci or signs of significant new infections considered to be related to lavage treatment) in the three groups of patients.
Measured: one month
Re-treatment with bronchoalveolar lavage
Hospitalisation for acute exacerbations requiring re-bronchoscopic lavage within 6 months in all three groups (re-bronchoscopic lavage may be considered for exacerbations after treatment: significant increase in sputum output, increase in the size of the lesion on CT).
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start14 Aug 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis with Acute ExacerbationStudies of the same condition, open and under way.
- 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
- Control group A (conventional clinical treatment), Control group B (application of saline bronchoalveolar lavage based on conventional clinical treatment), and group C (application of bronchoscopic acetylcysteine combined with saline alveolar lavage based on conventional clinical treatment), were randomly selected into the groups according to a predefined sequence of randomisation tables prior to the operation due to the nature of the intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Collaborators
- Shenzhen Third People's Hospital, Anhui Chest Hospital, Ninghai First Hospital, Jingzhou Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726356
- Sponsor's protocol ID
- 2024-R036-01
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bronchoalveolar Lavage with Acetylcysteine in the Treatment of Bronchiectasis with Infection in Adults: a Multicentre, Blinded, Randomised Controlled Study.
- ClinicalTrials.gov ID
- NCT06726356
- Acronym / sponsor ID
- 2024-R036-01
- Conditions
- Bronchiectasis with Acute Exacerbation
- Keywords
- bronchiectasis; acetylcysteine; bronchoalveolar lavage; Bronchoscopic airway clearance therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Collaborators
- Shenzhen Third People's Hospital, Anhui Chest Hospital, Ninghai First Hospital, Jingzhou Central Hospital
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 10 Dec 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.
Bronchiectasis is a clinical syndrome characterised by chronic cough, profuse sputum and/or intermittent haemoptysis, with or without shortness of breath and respiratory failure of varying severity, and abnormal thickening and dilatation of the bronchial walls as seen on lung imaging. Nebulised inhalation of N-acetylcysteine has been shown to significantly improve symptoms, shorten the length of hospital stay, reduce the rate of re-hospitalisation within six months, and improve lung function in patients with bronchiectasis with a high degree of safety. There have been no studies on the efficacy and safety of bronchoscopic irrigation with N-acetylcysteine solution in the treatment of bronchiectasis. The aim of this study was to investigate whether bronchoscopic acetylcysteine lavage combined with conventional treatment is more beneficial to patients with bronchiectasis than conventional treatment combined with conventional bronchoalveolar lavage and conventional treatment without bronchoscopy, respectively.
Detailed description
All patients enrolled were patients with acute exacerbation of bronchiectasis. A total of 180 patients (1:1:1 allocation) with acute exacerbation of bronchiectasis were to be enrolled. The patients were divided into control group A (conventional clinical treatment including anti-infective and expectorant therapy), control group B (bronchoalveolar lavage with saline on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml), and experimental group C (bronchoalveolar lavage with acetylcysteine solution in combination with saline on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Control group A (conventional clinical treatment), Control group B (application of saline bronchoalveolar lavage based on conventional clinical treatment), and group C (application of bronchoscopic acetylcysteine combined with saline alveolar lavage based on conventional clinical treatment), were randomly selected into the groups according to a predefined sequence of randomisation tables prior to the operation due to the nature of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –based on conventional clinical treatment including anti-infective and expectorant therapy. |
| Group B | Other | Procedure: Bronchoalveolar LavageBronchoalveolar lavage with saline on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml. |
| Group C | Experimental | Procedure: Bronchoalveolar LavageBronchoalveolar lavage with acetylcysteine solution in combination with saline on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years and ≤80 years;
- Chest CT suggestive of bronchiectasis;
- meet the criteria for an acute exacerbation of bronchiectasis with symptoms such as cough, sputum, chest tightness or wheezing, and c. Patients who meet the criteria for an acute exacerbation of bronchiectasis with symptoms of cough, sputum, chest tightness or wheezing and who consent to bronchoscopy with bronchoalveolar lavage
- patients who agreed to participate in the study and signed an informed consent form;
Key exclusion criteria (6 listed)
- Severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, psychiatric disorders or severe neuroses that are contraindications to bronchoscopy;
- Intraoperative findings of decreased SPO2 or inability to tolerate bronchoscopy or inability to tolerate further bronchoalveolar lavage;
- Inability to co-operate with the study for any reason or in the opinion of the investigator, inappropriate for inclusion in the study for other reasons;
- Bronchoscopy of patients with significant intra-airway haemorrhage who may be at risk of exacerbation due to bronchoalveolar lavage;
- Patients with acetylcysteine allergy;
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 |
|---|---|---|
| Bronchoalveolar LavageBronchoalveolar lavage with saline or saline-acetylcysteine solution on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml. | Procedure or surgery | Group B, Group C |
Primary outcome
Time of first and second acute exacerbation
Time frame: six months
Description: Length of post-treatment time points to first acute exacerbation (days) and length of time points to second acute exacerbation (days) in all three groups of patients.
7 secondary outcomes
The change of mMRC scores
Time frame: one month
The change of CAT scores.
Time frame: one month
The change of LCQ scores.
Time frame: one month
The change of SGQR scores.
Time frame: one month
Number of acute exacerbations
Time frame: six months
adverse effects
Time frame: one month
Re-treatment with bronchoalveolar lavage
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Bronchiectasis with Acute Exacerbation
RecruitingObservational study
Study of Bronchiectasis and Associated Cardiovascular Comorbidities
Bronchiectasis
RecruitingObservational study
Study of Hospitalised Patients With Acute Respiratory Conditions
Acute Respiratory Disease, COPD Exacerbation Acute
RecruitingPhase 4
Azithromycin to Modify Bronchiectasis Exacerbation Risk
Non-cystic Fibrosis Bronchiectasis, Bronchiectasis Adult
Recruiting
Efficacy and Safety of Bronchoscopic Local Amikacin Instillation for Acute Exacerbations of Bronchiectasis in Adults: A Multicenter, Blinded, Randomized Controlled Trial
Bronchiectasis With Acute Exacerbation
RecruitingObservational study
Bronchiectasis Phenotype Identification Model
Bronchiectasis, Non-cystic Fibrosis Bronchiectasis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoalveolar Lavage in people with Bronchiectasis with Acute Exacerbation, run by First Affiliated Hospital of Ningbo University 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongbo Chen (13777125910, leonczb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of first and second acute exacerbation (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.