Back to resultsTherapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis
Primary Purpose
Bronchiectasis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bronchoalveolar Lavage and Local Amikacin Injection
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis
Eligibility Criteria
Inclusion Criteria:
- Age≥18 years and ≤80 years;
- Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT;
- Are sensitive to amikacin;
- Acute exacerbation of bronchiectasis;
- Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc;
- Willing to join in and sign the informed consent form.
Exclusion Criteria:
- Active bleeding without control；
- Receiving nasal or facial surgery recently；
- With severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc.
- With other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc.
- Be allergic to amikacin
Sites / Locations
- Shanghai Pulmonary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
The experimental group
The controlled group
Arm Description
fundamental treatment combining with the therapy of bronchoalveolar lavage and local Amikacin injection.(fundamental treatment including anti-infection,eliminating phlegm,oxygen therapy etc.)
fundamental treatment(including anti-infection,eliminating phlegm,oxygen therapy etc.)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Full Information
NCT ID
NCT02509091
First Posted
July 22, 2015
Last Updated
August 21, 2018
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
1. Study Identification
Unique Protocol Identification Number
NCT02509091
Brief Title
Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis
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 Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The experimental group
Arm Type
Experimental
Arm Description
fundamental treatment combining with the therapy of bronchoalveolar lavage and local Amikacin injection.(fundamental treatment including anti-infection,eliminating phlegm,oxygen therapy etc.)
Arm Title
The controlled group
Arm Type
No Intervention
Arm Description
fundamental treatment(including anti-infection,eliminating phlegm,oxygen therapy etc.)
Intervention Type
Drug
Intervention Name(s)
Bronchoalveolar Lavage and Local Amikacin Injection
Other Intervention Name(s)
Amikin;AMK
Intervention Description
injecting 0.4g of AK in 100 ml to 250 ml, not exceeding 300 ml. And generally, repeat it for 3 to 5 times.
Primary Outcome Measure Information:
Title
Improvement of Sputum volume and properties
Description
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
Time Frame
90 days
Secondary Outcome Measure Information:
Title
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))
Description
Lung function will be measured as improved/stabilized/exacerbated from baseline to 30 days/60 days/90 days
Time Frame
90 days
Title
Dyspnea score according by Modified Medical Research Center(MMRC)
Description
to measure rating dyspnea according by Medi Medical Research Center(MMRC) from baseline to 30 days/60 days/90 days
Time Frame
90 days
Title
Cough score according by Leicester Cough Questionnaire(LCQ)
Description
to measure rating cough according by Leicester Cough Questionnaire(LCQ) from baseline to 30 days/60 days/90 days
Time Frame
90 days
Title
Life quality: assessed by St. George respiratory questionnaire (SGRQ)
Description
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
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age≥18 years and ≤80 years;
Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT;
Are sensitive to amikacin;
Acute exacerbation of bronchiectasis;
Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc;
Willing to join in and sign the informed consent form.
Exclusion Criteria:
Active bleeding without control；
Receiving nasal or facial surgery recently；
With severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc.
With other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc.
Be allergic to amikacin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Fu Xu, MD
Phone
+86 13321922898
Email
13321922898@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Fu Xu, MD
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke Fei
Phone
+86 21 65115006
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis
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