Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis
Information source: Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchiectasis
Intervention: Bronchoalveolar Lavage and Local Amikacin Injection (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Shanghai Pulmonary Hospital, Shanghai, China Official(s) and/or principal investigator(s):
Jin-Fu Xu, MD, Principal Investigator, Affiliation: Shanghai Pulmonary Hospital, Shanghai, China
Overall contact:
Jin-Fu Xu, MD, Phone: +86 13321922898, Email: 13321922898@163.com
Summary
The therapy of bronchoalveolar lavage and local amikacin injection as one of the treatment
of bronchiectasis developed in recent years. this study is aim to evaluate the Clinical
Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in
Patients with Acute Exacerbation of Bronchiectasis.
Clinical Details
Official title: Clinical Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis:An Open-label Randomized Parallel Controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Improvement of Sputum volume and properties
Secondary outcome: changes in lung function (including Forced expiratory volume in one second (FEV1) ,forced vital capacity(FVC) and forced vital capacity rate of one second(FEV1/FVC))Dyspnea score according by Modified Medical Research Center(MMRC) Cough score according by Leicester Cough Questionnaire(LCQ) Life quality: assessed by St. George respiratory questionnaire (SGRQ)
Detailed description:
The aim of this study was to evaluate the efficacy and safety of The therapy of
bronchoalveolar lavage and local amikacin injection through the observation of a large
sample of clinical cases. During the observation, study visits will occur at the end of
30days, 60days, 90days. all the participants will be required to check the various efficacy
and safety indicators.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age≥18 years and ≤80 years;
2. Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT;
3. Are sensitive to amikacin;
4. Acute exacerbation of bronchiectasis;
5. Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function
testing etc;
6. Willing to join in and sign the informed consent form.
Exclusion Criteria:
1. Active bleeding without control；
2. Receiving nasal or facial surgery recently；
3. With severe cardio-pulmonary dysfunction, such as left heart failure, unstable
arrhythmia, etc.
4. With other respiratory diseases: such as active pulmonary tuberculosis,
non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc.
5. Be allergic to amikacin
Locations and Contacts
Jin-Fu Xu, MD, Phone: +86 13321922898, Email: 13321922898@163.com
Shanghai Pulmonary Hospital, Shanghai, Shanghai 200000, China; Recruiting
Ke Fei, Phone: +86 21 65115006
Additional Information
Starting date: December 2014
Last updated: July 24, 2015
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