Phase 4
N=152
Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
Non-Cystic Fibrosis Bronchiectasis
Bottom Line
View on ClinicalTrials.gov: NCT02081963 ↗Enrolled (actual)
152
Serious AEs
2.6%
Results posted
Apr 2019
Primary outcome: Primary: Bacterial Clearance Rate of Sputum — 38; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Amikacin (Drug); Normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Qilu Hospital of Shandong University
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacterial Clearance Rate of Sputum |
38; 16 | — |
| SECONDARY Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment |
18.4; 16.5 | — |
| SECONDARY Sputum Property Score After 14 Days of Treatment |
1.3; 1.3 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment |
56.9; 60.0 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment |
1.3; 1.5 | — |
Summary
This is a multi-centered, randomized, controlled study to assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02081963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.