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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IPC-15005915 |
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Date of registration:
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2014-07-06 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis
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Scientific title:
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A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis |
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Date of first enrolment:
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2015-01-31 |
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Target sample size:
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Experimental group:50; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=10373 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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New Treatment Measure Clinical Study
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Contacts
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Name:
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Jinfu Xu
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Address:
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NO.507, Zhengmin Road, Shanghai, China
200433
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Telephone:
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+86 13321922898 |
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Email:
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13321922898@163.com |
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Affiliation:
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Name:
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Haiwen Lu
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Address:
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NO.507, Zhengmin Road, Shanghai, China
200433
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Telephone:
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+86 13917110982 |
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Email:
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haiwen_lu@163.com |
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Affiliation:
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Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male or female aged between 18 to 80 years;
2. Confirmed diagnosis of non-cystic fibrosis bronchiectasis;
3. Acute exacerbation of bronchiectasis;
4. Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing, 6-minute walk test (6MWT), etc.
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. Pregnant women;
5. with other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis;
5. Be allergic to amikacin or not tolerant to nebulised amikacin.
Age minimum:
18
Age maximum:
80
Gender:
Both
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Health Condition(s) or Problem(s) studied
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non-cystic fibrosis bronchiectasis
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Intervention(s)
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Experimental group:Routine treatment combining with the therapy of bronchoalveolar lavage and local drug injection (Amikacin);
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Primary Outcome(s)
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LCQ score;mMRC score;SGRQ score;PFT;The rate of sputum bacterial clearance;
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Source(s) of Monetary Support
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prepare funding by ourselves
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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