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

NCT02509091 | Unknown Phase 4 DMC

• 1 other identifier: 20150616
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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))

  90 days

• Dyspnea score according by Modified Medical Research Center(MMRC)

  90 days

• Cough score according by Leicester Cough Questionnaire(LCQ)

  90 days

• Life quality: assessed by St. George respiratory questionnaire (SGRQ)

  90 days

Study Arms (2)

The experimental group

EXPERIMENTAL

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

The controlled group

NO INTERVENTION

fundamental treatment(including anti-infection,eliminating phlegm,oxygen therapy etc.)

Interventions

Bronchoalveolar Lavage and Local Amikacin Injection DRUG

injecting 0.4g of AK in 100 ml to 250 ml, not exceeding 300 ml. And generally, repeat it for 3 to 5 times.

Also known as: Amikin;AMK

The experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Jin-Fu Xu, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Fu Xu, MD

CONTACT

+86 13321922898; 13321922898@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of respiratory medicine

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 27, 2015
• Study Start: December 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

CN (1)