BronchiectasisNCT06106789
A Study of the Clinical Benefit of Tobramycin Inhalation Solution
An observational study of Bronchiectasis and Cystic Fibrosis, run by Qianfoshan Hospital at 1 site in China.
Trial summary
This project will use literature analysis, expert research, real-world data mining and other methods to investigate the current status of the application of antimicrobial aerosolized inhalation in healthcare institutions, combine expert recommendations and real-world data analysis results to explore potential risk… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchiectasis, Cystic Fibrosis, Lung Infection
- What is being tested?
- Tobramycin inhalation solution
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients seen or admitted to the hospital (including outpatient, emergency, and inpatient) from January 1, 2021 - December 31, 2023, including: 1. Patients with bronchiectasis combined with P. aeruginosa infection: nebulized inhaled antimicrobials to clear pathogens or to reduce pathogen load; 2. Patients with cystic fibrosis combined with P. aeruginosa infection: nebulized inhaled antimicrobials to clear pathogens or to reduce pathogen load; 3. Patients with multidrug-resistant bacterial lung infections using inhaled antimicrobials as an adjunctive therapeutic regimen to intravenous administration.
Who may be able to join
- Bronchiectasis
- Patients with a past medical history or a diagnosis of bronchiectasis in the current case;
- Patients seen or admitted to the hospital from 1 January 2021 to 31 December 2023 (including outpatient, emergency, and inpatient);
- Case record of at least 1 course of treatment (continuous administration for 28 days) with tobramycin inhalation solution or other antibiotic nebulisation;
- Patients with a positive copper-green test at the first visit.
- Cystic fibrosis
Show all 15Show fewer
- Patients with a past medical history or a diagnosis of cystic fibrosis in the current case;
- Patients who were seen or admitted to the hospital from 1 January 2021 to 31 December 2023 (including outpatient, emergency, and inpatient);
- Case record of at least 1 course of treatment (continuous administration for 28 days) with tobramycin inhalation solution or other antibiotic nebulisation;
- Patients with a positive copper-green test at the first visit.
- Multidrug-resistant bacterial lung infections
- Patients with a diagnosis of pulmonary infection;
- Patients admitted to the hospital from 1 January 2021 to 31 December 2023 (only inpatients were included);
- Case records with completion of at least 3 days of treatment with tobramycin inhalation solution or other antibiotic nebulisation;
- The patient tested positive for pathogens at least once during the period of medication.
Who cannot join
- Bronchiectasis Patients with key information missing from the study, such as therapeutic agents, diagnostic information for bronchiectasis, etc.
- Cystic fibrosis Patients with cystic fibrosis, for which key information is missing, such as treatment medication, diagnosis of cystic fibrosis.
- Multidrug-resistant bacterial lung infections Patients hospitalized with severe pneumonia were missing key study information, such as laboratory tests not performed.
Trial locations and contacts
1 site in 1 country.
About this study
This project will use literature analysis, expert research, real-world data mining and other methods to investigate the current status of the application of antimicrobial aerosolized inhalation in healthcare institutions, combine expert recommendations and real-world data analysis results to explore potential risk points in the process of antimicrobial aerosolized drug delivery, and sort out the key points of drug use management in healthcare institutions and the key points of regulatory recommendations for healthcare institutions.
Read the detailed description
The current status of nebulised inhalation of antimicrobial drugs was examined by the main subject through literature search and expert research. The researchers selected patients who visited or were admitted to Qianfoshan Hospital in Shandong Province during the period from 1 January 2021 to 31 December 2023, extracted data according to the inclusion and exclusion criteria, and used tobramycin inhalation solution as the study group, and injectable antimicrobials used by inhalation such as amikacin, polymyxin E sodium methanesulfonate, polymyxin E sulphate, polymyxin B sulphate and other antimicrobials in a multicentre real-world cohort study as the control group, and adopted a multi A multi-centre real-world cohort study was conducted to examine the effectiveness, safety and economy of nebulised inhalation of antimicrobial drugs in different levels of healthcare institutions in China, to directly compare the risk of use of injectable over-the-counter nebulised inhalation with that of inhalation formulations, and also to provide post-marketing re-evaluation for the newly marketed tobramycin inhalation solution and to provide evidence-based evidence for the rational use of medication in the clinic.
- Conditions
- Bronchiectasis, Cystic Fibrosis, Lung Infection
- Being tested
- Tobramycin inhalation solution
- Keywords
- Bronchiectasis, Cystic Fibrosis, Lung Infection, Tobramycin inhalation solution, Antimicrobial non-nebulized inhalation preparations, Safety, Efficacy, Economical
- Medical subject headings
- Bronchiectasis, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobramycin inhalation solutionDrug
Also called Antimicrobial non-nebulized inhalation preparations
Tobramycin Inhalation Solution is a yellowish clear liquid, the main ingredient is tobramycin.
Antimicrobial non-nebulized inhalation preparation according to the current clinical situation, mainly polymyxin, amikacin, depending on the specific circumstances of each hospital.
| Study group | Role | What they receive |
|---|---|---|
| Bronchiectasis | 1. Patients with a past medical history or a diagnosis of bronchiectasis in the current case;
2. Patients seen or admitted to the hospital from 1 January 2021 to 31 December 2023 (including outpatient, emergency, and inpatient);
3. Case record of at least 1 course of treatment (continuous administration for 28 days) with tobramycin inhalation solution or other antibiotic nebulisation;
4. Patients with a positive copper-green test at the first visit. Receives: Drug: Tobramycin inhalation solution | |
| Cystic fibrosis | 1. Patients with a past medical history or a diagnosis of cystic fibrosis in the current case;
2. Patients who were seen or admitted to the hospital from 1 January 2021 to 31 December 2023 (including outpatient, emergency, and inpatient);
3. Case record of at least 1 course of treatment (continuous administration for 28 days) with tobramycin inhalation solution or other antibiotic nebulisation;
4. Patients with a positive copper-green test at the first visit. Receives: Drug: Tobramycin inhalation solution | |
| Multidrug-resistant bacterial lung infections | 1. Patients with a diagnosis of pulmonary infection;
2. Patients admitted to the hospital from 1 January 2021 to 31 December 2023 (only inpatients were included);
3. Case records with completion of at least 3 days of treatment with tobramycin inhalation solution or other antibiotic nebulisation;
4. The patient tested positive for pathogens at least once during the period of medication. Receives: Drug: Tobramycin inhalation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Adverse Reaction Incidence Rate
To evaluate the safety of injectable over-the-counter nebulized inhalation versus inhalation formulations by analyzing the incidence of total adverse reactions, and to provide first-line, real-world data to support post-market re-evaluation.
Measured: Through study completion，up to half a year.
Pathogen clearance
To evaluate the effectiveness of the clinical application of injectable over-the-counter nebulized inhalation versus inhalation formulations by analyzing the pathogen clearance rate, and to provide first-line real-world data support for post-market re-evaluation of the product.
Measured: Through study completion，up to half a year.
Average hospitalization cost per visit
To provide first-line, real-world data support for post-market re-evaluation of the product by analyzing the average per-hospitalization cost to evaluate the economics of the clinical application of injectable over-the-counter nebulized inhalation versus inhalation formulations.
Measured: Through study completion，up to half a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Apr 2023
- Primary completion30 Apr 2024
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Yang, Qianfoshan Hospital
- Investigators
- Rui Yang, MD, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106789
- Sponsor's protocol ID
- LCYX-YR-20230101
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Clinical Benefit of Tobramycin Inhalation Solution
- ClinicalTrials.gov ID
- NCT06106789
- Acronym / sponsor ID
- LCYX-YR-20230101
- Conditions
- Bronchiectasis, Cystic Fibrosis, Lung Infection
- Keywords
- Bronchiectasis, Cystic Fibrosis, Lung Infection, Tobramycin inhalation solution, Antimicrobial non-nebulized inhalation preparations, Safety, Efficacy, Economical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will use literature analysis, expert research, real-world data mining and other methods to investigate the current status of the application of antimicrobial aerosolized inhalation in healthcare institutions, combine expert recommendations and real-world data analysis results to explore potential risk points in the process of antimicrobial aerosolized drug delivery, and sort out the key points of drug use management in healthcare institutions and the key points of regulatory recommendations for healthcare institutions.
Detailed description
The current status of nebulised inhalation of antimicrobial drugs was examined by the main subject through literature search and expert research. The researchers selected patients who visited or were admitted to Qianfoshan Hospital in Shandong Province during the period from 1 January 2021 to 31 December 2023, extracted data according to the inclusion and exclusion criteria, and used tobramycin inhalation solution as the study group, and injectable antimicrobials used by inhalation such as amikacin, polymyxin E sodium methanesulfonate, polymyxin E sulphate, polymyxin B sulphate and other antimicrobials in a multicentre real-world cohort study as the control group, and adopted a multi A multi-centre real-world cohort study was conducted to examine the effectiveness, safety and economy of nebulised inhalation of antimicrobial drugs in different levels of healthcare institutions in China, to directly compare the risk of use of injectable over-the-counter nebulised inhalation with that of inhalation formulations, and also to provide post-marketing re-evaluation for the newly marketed tobramycin inhalation solution and to provide evidence-based evidence for the rational use of medication in the clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bronchiectasis | – | Drug: Tobramycin inhalation solution1. Patients with a past medical history or a diagnosis of bronchiectasis in the current case; 2. Patients seen or admitted to the hospital from 1 January 2021 to 31 December 2023 (including outpatient, emergency, and inpatient); 3. Case record of at least 1 course of treatment (continuous administration for 28 days) with tobramycin inhalation solution or other antibiotic nebulisation; 4. Patients with a positive copper-green test at the first visit. |
| Cystic fibrosis | – | Drug: Tobramycin inhalation solution1. Patients with a past medical history or a diagnosis of cystic fibrosis in the current case; 2. Patients who were seen or admitted to the hospital from 1 January 2021 to 31 December 2023 (including outpatient, emergency, and inpatient); 3. Case record of at least 1 course of treatment (continuous administration for 28 days) with tobramycin inhalation solution or other antibiotic nebulisation; 4. Patients with a positive copper-green test at the first visit. |
| Multidrug-resistant bacterial lung infections | – | Drug: Tobramycin inhalation solution1. Patients with a diagnosis of pulmonary infection; 2. Patients admitted to the hospital from 1 January 2021 to 31 December 2023 (only inpatients were included); 3. Case records with completion of at least 3 days of treatment with tobramycin inhalation solution or other antibiotic nebulisation; 4. The patient tested positive for pathogens at least once during the period of medication. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seen or admitted to the hospital (including outpatient, emergency, and inpatient) from January 1, 2021 - December 31, 2023, including: 1. Patients with bronchiectasis combined with P. aeruginosa infection: nebulized inhaled antimicrobials to clear pathogens or to reduce pathogen load; 2. Patients with cystic fibrosis combined with P. aeruginosa infection: nebulized inhaled antimicrobials to clear pathogens or to reduce pathogen load; 3. Patients with multidrug-resistant bacterial lung infections using inhaled antimicrobials as an adjunctive therapeutic regimen to intravenous administration.
Key inclusion criteria (15 listed)
- Bronchiectasis
- Cystic fibrosis
- Multidrug-resistant bacterial lung infections
Key exclusion criteria (3 listed)
- Bronchiectasis Patients with key information missing from the study, such as therapeutic agents, diagnostic information for bronchiectasis, etc.
- Cystic fibrosis Patients with cystic fibrosis, for which key information is missing, such as treatment medication, diagnosis of cystic fibrosis.
- Multidrug-resistant bacterial lung infections Patients hospitalized with severe pneumonia were missing key study information, such as laboratory tests not performed.
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 |
|---|---|---|
| Tobramycin inhalation solutionAlso: Antimicrobial non-nebulized inhalation preparationsTobramycin Inhalation Solution is a yellowish clear liquid, the main ingredient is tobramycin. Antimicrobial non-nebulized inhalation preparation according to the current clinical situation, mainly polymyxin, amikacin, depending on the specific circumstances of each hospital. | Drug | Bronchiectasis, Cystic fibrosis, Multidrug-resistant bacterial lung infections |
Primary outcome
Total Adverse Reaction Incidence Rate
Time frame: Through study completion，up to half a year.
To evaluate the safety of injectable over-the-counter nebulized inhalation versus inhalation formulations by analyzing the incidence of total adverse reactions, and to provide first-line, real-world data to support post-market re-evaluation.
Pathogen clearance
Time frame: Through study completion，up to half a year.
To evaluate the effectiveness of the clinical application of injectable over-the-counter nebulized inhalation versus inhalation formulations by analyzing the pathogen clearance rate, and to provide first-line real-world data support for post-market re-evaluation of the product.
Average hospitalization cost per visit
Time frame: Through study completion，up to half a year.
To provide first-line, real-world data support for post-market re-evaluation of the product by analyzing the average per-hospitalization cost to evaluate the economics of the clinical application of injectable over-the-counter nebulized inhalation versus inhalation formulations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Bronchiectasis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Not yet recruitingPhase 3
A Study to Learn How Well People With Bronchiectasis Tolerate Continued Treatment With Verducatib After Earlier Studies (AIRTIVITY®-ON)
Bronchiectasis
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.
Rui Yang, MD principal investigator
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis and Cystic Fibrosis, run by Qianfoshan Hospital 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 15 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Oct 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
Total Adverse Reaction Incidence Rate (time frame: Through study completion，up to half a year.). The study lists 3 primary outcomes in all. 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 17 Oct 2024.