BronchiectasisPhase 4NCT01677403
A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis
A Phase 4 study testing Tobramycin and Saline in people with Bronchiectasis, run by Shandong University at 1 site in China.
Trial summary
This is a study to evaluate the efficacy,indications,adverse reactions and resistance of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Tobramycin and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Dec 2014
- Phase
- Phase 4
- 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 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 P. aeruginosa at screening
- Are sensitive to Tobramycin
- 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.
- Are not tolerant to nebulised tobramycin
- FEV1.0 reduces ≥ 15% after inhaling tobramycin. -
Trial locations and contacts
1 site in 1 country.
Qi contact
About this study
Official title: A Randomized,Controlled Study to Evaluate the Efficacy,Indications,Adverse Reactions and Resistance of Combined Administration of Nebulized Tobramycin Compared With Systemic Administration Alone in Patients With Bronchiectasis
This is a study to evaluate the efficacy,indications,adverse reactions and resistance of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.
Read the detailed description
Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response is typical of the disease. The chronic nature of the infection and the associated considerable morbidity provides the rationale for using aerosolized antibiotics for the treatment of bronchiectasis patients.
This is a study of safety and efficacy of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis. Study subjects will be randomized to receive either study drug or placebo by inhalation via a nebulizer. Each subject will complete 14 days of daily dosing.
Clinical laboratory parameters,clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and efficacy of nebulized tobramycin.
- Conditions
- Bronchiectasis
- Being tested
- Tobramycin, Saline
- Keywords
- Bronchiectasis, Tobramycin, nebulised
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobramycinDrug
Nebulised 80mg twice daily
SalineDrug
Nebulised 5mls 0.9% Saline twice daily
| Study group | Role | What they receive |
|---|---|---|
| Nebulised Tobramycin | Active comparator | Nebulised Tobramycin Receives: Drug: Tobramycin |
| Nebulised 0.9% Saline | Placebo comparator | Nebulised 0.9% Saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate change in density of Pseudomonas aeruginosa in sputum
Measured: days 1,7,14
Secondary outcomes (3)
To evaluate chang in the amount of sputum
Measured: days 1,7,14
To evaluate chang in patients' cough severity
Measured: days 1,7,14
To evaluate change in pulmonary function
Measured: days 1,7,14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (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.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Qian, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677403
- Sponsor's protocol ID
- qlhqiqian
- Other IDs
- QL
- Status last verified
- Dec 2012
- First submitted
- 26 Aug 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Controlled Study to Evaluate the Efficacy,Indications,Adverse Reactions and Resistance of Combined Administration of Nebulized Tobramycin Compared With Systemic Administration Alone in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT01677403
- Acronym / sponsor ID
- qlhqiqian
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Tobramycin, nebulised
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 3 Sep 2012 (estimated)
- 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 is a study to evaluate the efficacy,indications,adverse reactions and resistance of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.
Detailed description
Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response is typical of the disease. The chronic nature of the infection and the associated considerable morbidity provides the rationale for using aerosolized antibiotics for the treatment of bronchiectasis patients.
This is a study of safety and efficacy of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis. Study subjects will be randomized to receive either study drug or placebo by inhalation via a nebulizer. Each subject will complete 14 days of daily dosing.
Clinical laboratory parameters,clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and efficacy of nebulized tobramycin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulised Tobramycin | Active comparator | Drug: TobramycinNebulised Tobramycin |
| Nebulised 0.9% Saline | Placebo comparator | Drug: SalineNebulised 0.9% Saline |
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 P. aeruginosa at screening
- Are sensitive to Tobramycin
- Acute exacerbation of bronchiectasis -
Key exclusion criteria (6 listed)
- Bronchiectasis due to special causes.
- Smokers.
- Are associated with bronchial asthma.
- Have any serious or active medical or psychiatric illness.
- Are not tolerant to nebulised tobramycin
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 |
|---|---|---|
| TobramycinNebulised 80mg twice daily | Drug | Nebulised Tobramycin |
| SalineNebulised 5mls 0.9% Saline twice daily | Drug | Nebulised 0.9% Saline |
Primary outcome
To evaluate change in density of Pseudomonas aeruginosa in sputum
Time frame: days 1,7,14
3 secondary outcomes
To evaluate chang in the amount of sputum
Time frame: days 1,7,14
To evaluate chang in patients' cough severity
Time frame: days 1,7,14
To evaluate change in pulmonary function
Time frame: days 1,7,14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
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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.
Qi contact
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 Tobramycin and Saline in people with Bronchiectasis, run by 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 6 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 5 Dec 2012. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi (xiaokangqlh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate change in density of Pseudomonas aeruginosa in sputum (time frame: days 1,7,14). 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 5 Dec 2012.