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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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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02081963 |
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Date of registration:
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06/03/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
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Scientific title:
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A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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178 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02081963 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Yu Li, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Director |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female study subjects =18 years of age and =80 years of age;
- Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis;
- Confirmation of infection with Pseudomonas aeruginosa at screening;
- Are sensitive to amikacin;
- Acute exacerbation of bronchiectasis.
Exclusion Criteria:
- Bronchiectasis due to special causes;
- Smokers;
- Are associated with bronchial asthma;
- Have any serious or active medical or psychiatric illness;
- Be allergic to amikacin or not tolerant to nebulised amikacin(FEV1 reduces =15% after
inhaling amikacin.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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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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Drug: Normal saline
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Drug: Amikacin
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Primary Outcome(s)
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Bacterial Clearance Rate of Sputum
[Time Frame: after 14 days]
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Secondary Outcome(s)
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Sputum Property Score After 14 Days of Treatment
[Time Frame: after 14 days]
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Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment
[Time Frame: after 14 days]
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Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment
[Time Frame: after 14 days]
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Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment
[Time Frame: after 14 days]
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Secondary ID(s)
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NCFB-AMK-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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