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

August 21, 2018 updated by: Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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))
Time Frame: 90 days
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)
Time Frame: 90 days
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)
Time Frame: 90 days
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)
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
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20150616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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