Non-Cystic Fibrosis BronchiectasisPhase 4NCT02081963
Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
A Phase 4 study testing Amikacin and Normal saline in people with Non-Cystic Fibrosis Bronchiectasis, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Cystic Fibrosis Bronchiectasis
- What is being tested?
- Amikacin and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
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.
Read the detailed description
Objective: 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.
Methods: Patients with acute exacerbation of non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive nebulized amikacin BID for 14 days in combination with standard treatment) or the control group (participants receive nebulized 0.9% saline BID for 14 days in combination with standard treatment). The primary endpoint was bacterial clearance rate of sputum.
Expected results: Compared with the control group, bacterial clearance rate of sputum of the observer Group will increase significantly.
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Being tested
- Amikacin, Normal saline
- Keywords
- Nebulized amikacin;, Non-Cystic Fibrosis Bronchiectasis;, Bacterial clearance rate of sputum；, Acute exacerbation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmikacinDrug
Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.
Normal salineDrug
Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized amikacin | Experimental | Participants receive nebulized amikacin BID for 14 days in combination with standard treatment. Receives: Drug: Amikacin |
| Nebulized normal saline | Other | Participants received nebulized normal saline BID for 14 days in combination with standard treatment. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Clearance Rate of Sputum
The bacterial eradication rate of the sputum was calculated by the number of P. aeruginosa-eradicated cases according to sputum culture testing result. Sputum samples were collected in the morning after toothbrushing and gargling, before the patients used any medicine. Eligible sputum samples were defined as having ≥25 white blood cells/highpower field and ≤10 epithelial cells/high-power field; the samples were sent for testing within 60 min. Sputum samples were collected again after 14 days. If the second sputum culture test showed a negative result after the first one had been positive, it was defined as eradicated.
Measured: after 14 days
Secondary outcomes (4)
Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment
Measured: after 14 days
Sputum Property Score After 14 Days of Treatment
The sputum properties were graded from 1 to 4, with 1 being assigned to transparent mucous sputum, 2 to yellow purulent sputum, 3 to green purulent sputum, and 4 to black green purulent sputum. Higher scores mean a worse outcome.
Measured: after 14 days
Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment
Measured: after 14 days
Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment
Measured: after 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qilu Hospital of Shandong University
- Investigators
- Yu Li, Professor, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081963
- Sponsor's protocol ID
- NCFB-AMK-01
- Status last verified
- Nov 2015
- First submitted
- 6 Mar 2014
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT02081963
- Acronym / sponsor ID
- NCFB-AMK-01
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Keywords
- Nebulized amikacin;, Non-Cystic Fibrosis Bronchiectasis;, Bacterial clearance rate of sputum；, Acute exacerbation.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: 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.
Methods: Patients with acute exacerbation of non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive nebulized amikacin BID for 14 days in combination with standard treatment) or the control group (participants receive nebulized 0.9% saline BID for 14 days in combination with standard treatment). The primary endpoint was bacterial clearance rate of sputum.
Expected results: Compared with the control group, bacterial clearance rate of sputum of the observer Group will increase significantly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized amikacin | Experimental | Drug: AmikacinParticipants receive nebulized amikacin BID for 14 days in combination with standard treatment. |
| Nebulized normal saline | Other | Drug: Normal salineParticipants received nebulized normal saline BID for 14 days in combination with standard treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmikacinNebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment. | Drug | Nebulized amikacin |
| Normal salineNebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment. | Drug | Nebulized normal saline |
Primary outcome
Bacterial Clearance Rate of Sputum
Time frame: after 14 days
The bacterial eradication rate of the sputum was calculated by the number of P. aeruginosa-eradicated cases according to sputum culture testing result. Sputum samples were collected in the morning after toothbrushing and gargling, before the patients used any medicine. Eligible sputum samples were defined as having ≥25 white blood cells/highpower field and ≤10 epithelial cells/high-power field; the samples were sent for testing within 60 min. Sputum samples were collected again after 14 days. If the second sputum culture test showed a negative result after the first one had been positive, it was defined as eradicated.
4 secondary outcomes
Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment
Time frame: after 14 days
Sputum Property Score After 14 Days of Treatment
Time frame: after 14 days
Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment
Time frame: after 14 days
Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment
Time frame: after 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Li, Professor study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amikacin and Normal saline in people with Non-Cystic Fibrosis Bronchiectasis, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Clearance Rate of Sputum (time frame: after 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.