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| Name | Class |
|---|---|
| Shenzhen Third People's Hospital | OTHER |
| Anhui Chest Hospital | OTHER |
| Ninghai First Hospital | UNKNOWN |
| Jingzhou Central Hospital |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoalveolar Lavage | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one month |
| The change of CAT scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongbo Chen | Contact | 13777125910 | leonczb@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | 315010 | China |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D018893 | Bronchoalveolar Lavage |
| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
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| OTHER |
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.
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Subjects were blinded. Study personnel responsible for assessing patients' symptom scores and recording information on acute exacerbations were blinded whenever possible. The bronchoscopy operator responsible for giving bronchoalveolar lavage treatment and the person in charge of the patient's bed were not blinded. To avoid subjective bias on the part of the assessor, non-blind people should not disclose blinded information to the assessor.
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. |
| 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. | 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. | one month |
| Number of acute exacerbations | Number of acute exacerbations in the three groups at 6 months after treatment. | 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. | 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). | six months |