Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis

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

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.

Study Overview

• Status: Unknown
• Conditions: Bronchiectasis
• Intervention / Treatment: Drug: Bronchoalveolar Lavage and Local Amikacin Injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jin-Fu Xu, MD; Phone Number: +86 13321922898; Email: 13321922898@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Ke Fei; Phone Number: +86 21 65115006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group; fundamental treatment combining with the therapy of bronchoalveolar lavage and local Amikacin injection.(fundamental treatment including anti-infection,eliminating phlegm,oxygen therapy etc.)	Drug: Bronchoalveolar Lavage and Local Amikacin Injection; injecting 0.4g of AK in 100 ml to 250 ml, not exceeding 300 ml. And generally, repeat it for 3 to 5 times.; Other Names: Amikin;AMK
No Intervention: The controlled group; fundamental treatment(including anti-infection,eliminating phlegm,oxygen therapy etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Sputum volume and properties	Phlegm improvement will be measured by the reduction of the sputum volume and change of sputum properties in the first day,in admission,the first day before,in and after doing bronchoscopy ,the day in discharge and in 30 days/60 days/90 days	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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))	Lung function will be measured as improved/stabilized/exacerbated from baseline to 30 days/60 days/90 days	90 days
Dyspnea score according by Modified Medical Research Center(MMRC)	to measure rating dyspnea according by Medi Medical Research Center(MMRC) from baseline to 30 days/60 days/90 days	90 days
Cough score according by Leicester Cough Questionnaire(LCQ)	to measure rating cough according by Leicester Cough Questionnaire(LCQ) from baseline to 30 days/60 days/90 days	90 days
Life quality: assessed by St. George respiratory questionnaire (SGRQ)	Life quality will be assessed as improved if SGRQ single or total score increased >4% when completing the trial; stabilized if SGRQ single or total score changes within the range of 4% when completing the trial; exacerbated if SGRQ single or total score decreased >4% when completing the trial from baseline to 30 days/60 days/90 days	90 days

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: July 24, 2015
• First Posted (Estimate): July 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Anti-Bacterial Agents; Chelating Agents; Sequestering Agents; Amikacin; Dimercaprol
• Other Study ID Numbers: 20150616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided