Efficacy and Safety of Bronchoscopic Local Amikacin Instillation for Acute Exacerbations of Bronchiectasis in Adults: A Multicenter, Blinded, Randomized Controlled Trial
4. september 2026 oppdatert av: First Affiliated Hospital of Ningbo University
Bronchiectasis is a chronic respiratory system disease characterized by irreversible structural dilation of the bronchi, persistent cough, and alternating periods of stability and acute exacerbation during the clinical course.
Although airway clearance techniques (ACTs) are widely recommended, some hospitalized patients are unable to fully participate in conventional physical therapy due to respiratory difficulties or impaired sputum clearance.
Bronchoscopic airway clearance therapy (B-ACT), combined with bronchoalveolar lavage under direct bronchoscopic visualization, can remove airway secretions.
Previous studies have shown that bronchoscopy-guided airway clearance therapy (B-ACT) may prolong the time from discharge to the first exacerbation.
In China, there have been studies exploring the use of bronchoscopy-guided alveolar lavage combined with local application of amikacin to treat patients with bronchiectasis.
This study aims to explore whether the local application of amikacin after bronchoscopy-guided saline alveolar lavage provides greater benefits for patients with acute exacerbation of bronchiectasis compared to conventional treatment (non-bronchoscopy lavage) and bronchoscopy-guided saline alveolar lavage.
The goal is to apply this treatment method in clinical practice to reduce the frequency of acute exacerbations in patients with bronchiectasis, improve prognosis, and enhance quality of life.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
All enrolled patients are in the acute exacerbation phase of bronchiectasis.
A total of 186 patients with acute exacerbation of bronchiectasis (1:1:1 allocation) who are willing to participate in this study and sign an informed consent form will be enrolled.
The patients will be divided into three groups: Control Group A (based on routine clinical treatment, including anti-infection and expectorant therapy), Control Group B (in addition to routine use of antibacterial and expectorant medications, using bronchoscopy to wash the affected lung lobe with 180ml of saline), and Research Group C (in addition to routine use of antibacterial and expectorant medications, using bronchoscopy to wash the affected lung lobe with 180ml of saline, followed by local injection of a mixture formed by adding 2 vials of Amikacin (specification: 0.2g/2ml) to 20ml of saline into the target bronchiectasis area).
Studietype
Intervensjonell
Registrering (Antatt)
186
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Zhongbo Chen
- Telefonnummer: +8613777125910
- E-post: leonczb@163.com
Studiesteder
-
-
Zhejiang
-
Ningbo, Zhejiang, Kina, 315010
- Rekruttering
- The First Affiliated Hospital of Ningbo University
-
Ta kontakt med:
- Zhongbo Chen
- Telefonnummer: +8613777125910
- E-post: leonczb@163.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Aged between 18 and 80 years, inclusive.
- According to the adult bronchiectasis guidelines, diagnosed with bronchiectasis, and indicating lesions accumulating in 2 or more lung lobes.
- Presenting with an acute exacerbation, defined by worsening of key symptoms (e.g., cough, sputum volume, dyspnea, chest tightness, or wheezing), and willing to undergo bronchoscopy with bronchoalveolar lavage (BAL).
- Patients who are alert, cooperative, and able to tolerate the bronchoscopic procedure.
- Provided written informed consent to participate in this clinical trial.
Exclusion Criteria:
- Presence of severe comorbidities or any contraindications to flexible bronchoscopy.
- Intraoperative oxygen desaturation (SpO₂) or inability to tolerate bronchoalveolar lavage (BAL) following bronchoscopic insertion.
- Declined participation or was deemed ineligible by the investigator for other reasons.
- Coagulopathy (platelet count < 50 × 10⁹/L) or active airway bleeding observed during bronchoscopy, posing a potential risk of exacerbation from BAL.
- Incomplete procedural documentation or missing follow-up data.
- Known allergy or hypersensitivity to amikacin.
- Concurrent renal failure.
- Diagnosis of cystic fibrosis.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Group A
|
|
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Annen: Group B
While routinely using antibiotics and expectorants for treatment, perform bronchoscopy and lavage the affected lung lobe with 180ml of saline.
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While routinely using antibiotics and expectorants for treatment, perform bronchoscopy and lavage the affected lung lobe with 180ml of saline.
|
|
Eksperimentell: Group C
While routinely using antibiotics and expectorants for treatment, perform bronchoscopic lavage of the affected lung lobe with 180ml of saline; after lavage, locally inject a mixture of 2 vials of Amikacin (specification: 0.2g/2ml) mixed with 20ml of saline into the target bronchiectasis area.
|
While routinely using antibiotics and expectorants for treatment, perform bronchoscopic lavage of the affected lung lobe with 180ml of saline; after lavage, locally inject a mixture of 2 vials of Amikacin (specification: 0.2g/2ml) mixed with 20ml of saline into the target bronchiectasis area.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time of first acute exacerbation
Tidsramme: six months
|
Length of post-treatment time points to first acute exacerbation (days) in all three groups of patients.
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six months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
uønskede effekter
Tidsramme: en måned
|
Forekomst av bivirkninger etter behandling (tetthet i brystet, kortpustethet, forverring av respirasjonssvikt, forverring av hemoptyse, komplikasjon av nye lungebetennelsesfokus eller tegn på betydelige nye infeksjoner som anses å være relatert til skyllebehandling) hos de tre pasientgruppene.
|
en måned
|
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Re-behandling med bronkoalveolar lavage
Tidsramme: seks måneder
|
Sykehusinnleggelse for akutte eksaserbasjoner som krever re-bronkoskopisk skylling innen 6 måneder i alle tre gruppene (re-bronkoskopisk skylling kan vurderes ved eksaserbasjoner etter behandling: signifikant økning i sputumproduksjon, økning i størrelsen på lesjonen på CT).
|
seks måneder
|
|
The change of mMRC scores
Tidsramme: one month]
|
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
Tidsramme: one month
|
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
Tidsramme: one month
|
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
Tidsramme: one month
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Zhong NS, Qiu R, Cao J, Huang YM, Zhou H, Xu XX, Xu JF, Ye H, Yang ZR, Gao LY, Shen Y, Xiao ZK, Xie SG, Lin DJ, Zhao L, Xiong H, Zhang XM, Li FQ, Guan WJ, Chalmers JD; SAVE-BE trial investigators. Effects of the DPP-1 inhibitor HSK31858 in adults with bronchiectasis in China (SAVE-BE): a phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2025 May;13(5):414-424. doi: 10.1016/S2213-2600(25)00019-0. Epub 2025 Mar 25.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. mai 2026
Primær fullføring (Antatt)
15. september 2027
Studiet fullført (Antatt)
15. mai 2028
Datoer for studieregistrering
Først innsendt
4. september 2026
Først innsendt som oppfylte QC-kriteriene
4. september 2026
Først lagt ut (Faktiske)
10. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-R066-03
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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