Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02509091
Recruitment Status : Recruiting
First Posted : July 27, 2015
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Bronchoalveolar Lavage and Local Amikacin Injection Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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 Name: Amikin;AMK

No Intervention: The controlled group
fundamental treatment(including anti-infection,eliminating phlegm,oxygen therapy etc.)



Primary Outcome Measures :
  1. Improvement of Sputum volume and properties [ Time Frame: 90 days ]
    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 :
  1. 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)) [ Time Frame: 90 days ]
    Lung function will be measured as improved/stabilized/exacerbated from baseline to 30 days/60 days/90 days

  2. Dyspnea score according by Modified Medical Research Center(MMRC) [ Time Frame: 90 days ]
    to measure rating dyspnea according by Medi Medical Research Center(MMRC) from baseline to 30 days/60 days/90 days

  3. Cough score according by Leicester Cough Questionnaire(LCQ) [ Time Frame: 90 days ]
    to measure rating cough according by Leicester Cough Questionnaire(LCQ) from baseline to 30 days/60 days/90 days

  4. Life quality: assessed by St. George respiratory questionnaire (SGRQ) [ Time Frame: 90 days ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509091


Contacts
Layout table for location contacts
Contact: Jin-Fu Xu, MD +86 13321922898 13321922898@163.com

Locations
Layout table for location information
China, Shanghai
Shanghai Pulmonary Hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: Ke Fei    +86 21 65115006      
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
Layout table for investigator information
Principal Investigator: Jin-Fu Xu, MD Shanghai Pulmonary Hospital, Shanghai, China

Layout table for additonal information
Responsible Party: Jin-Fu Xu, Director, Head of respiratory medicine, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT02509091     History of Changes
Other Study ID Numbers: 20150616
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents