Non-CF BronchiectasisPhase 2/3BATTLENCT02657473
Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis
A Phase 2/3 study testing tobramycin inhalation solution and Saline 0.9% inhalation solution in people with Non-CF Bronchiectasis, run by Medical Center Alkmaar at 6 sites in Netherlands.
Trial summary
The purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS) once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint is a reduction of exacerbations of the disease during the treatment period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-CF Bronchiectasis
- What is being tested?
- tobramycin inhalation solution and Saline 0.9% inhalation solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 6 sitesNetherlands
- Study dates
- 13 Aug 2016to 13 Dec 2019
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum
- Confirmed non-CF bronchiectasis by (HR)CT
- Documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics within 12 months before inclusion.
- No course of antibiotics or maintenance antibiotics (except for macrolides) 1 month prior to the start of the study.
- Minimal one documented sputum or BAL-fluid culture with gram-negative bacteria or S.aureus within 12 months.
- Growth of protocol defined pathogens in sputum at screening visit sensitive to tobramycin
- Tolerance of inhaled tobramycin
Who cannot join
- Any exacerbation within the month prior to the start of the study
- Diagnosis of cystic fibrosis
- Active allergic bronchopulmonary aspergillosis (ABPA)
- Any oral, IV or inhaled antibiotics (except for macrolides) within 1 month prior to the start of the study
- Any IV or IM corticosteroids or change in oral corticosteroids (> 10 mg) within 1 month prior to the start of the study
- Any change/start treatment regimens macrolides, hypertonic saline, inhaled mannitol or other mucolytics, corticosteroids within 1 month prior to the start of the study
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- Change in physiotherapy technique or schedule within 1 month prior to the start of the study
- Severe immunosuppression or active malignancy
- Active tuberculosis
- Chronic renal insufficiency (eGFR < 30 ml/min), use of loop diuretics
- Have received an investigational drug or device within 1 month prior to the start of the study
- Serious or active medical or psychiatric illness
- Pregnancy and child bearing
- History of poor cooperation or non-compliance
- Unable to use nebulizers
- Allergic for tobramycin
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
North West Clinics
Alkmaar, North Holland, 1815JD
VU Medical Center
Amsterdam
Zuyderland Medisch Centrum
Heerlen
Spaarne Gasthuis
Hoofddorp
Canisius Ziekenhuis
Nijmegen
UMCU
Utrecht
About this study
Official title: Long-term Inhaled Nebulized Tobramycin in Patients With Non-cystic Fibrosis Bronchiectasis. A Randomized Placebo Controlled Trial. The BATTLE Study Bronchiectasis And Tobramycin SoluTion InhaLation ThErapy.
The purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS) once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint is a reduction of exacerbations of the disease during the treatment period. Next to this parameter the investigators expect to show a significant beneficial effect on lung function parameters, QoL, bacterial load of pathogens in sputum and tobramycin resistance.
Read the detailed description
See uploaded study protocol
- Conditions
- Non-CF Bronchiectasis
- Being tested
- tobramycin inhalation solution, Saline 0.9% inhalation solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tobramycin inhalation solutionDrug
Saline 0.9% inhalation solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| TIS 300mg once daily | Active comparator | Tobramycin inhalation solution (TIS) 300mg once daily for at least 9 months and up to 12 months Receives: Drug: tobramycin inhalation solution |
| Placebo once daily | Placebo comparator | Saline 0.9% inhalation solution 300mg once daily for at least 9 months and up to 12 months Receives: Drug: Saline 0.9% inhalation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exacerbations
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start13 Aug 2016
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-CF 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- . In present study the value of maintenance TIS will be investigated in patients with non-CF bronchiectasis colonized by different bacterial species sensitive for tobramycin. Objective: The primary outcome of the study is a 50% reduction in exacerbation rate in patients using maintenance TIS (OD). Secondary outcome parameters are lung function (FEV1, FVC), QoL (QOL-B), LTRI-VAS, Leicester cough score, bacterial load in sputum and tobramycin resistant pathogens. Study design: A randomised, double blind placebo controlled, multicenter study. Study population: Patients aged ≥ 18-year-old with confirmed bronchiectasis by (HR)CT and at least two exacerbations during previous 12 months.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W.G.Boersma, Medical Center Alkmaar
- Investigators
- Wim G. Boersma, Dr.MD, Principal investigator, Medical Center Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657473
- Sponsor's protocol ID
- 54939
- Acronym
- BATTLE
- Status last verified
- Dec 2019
- First submitted
- 13 Jan 2016
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Terpstra LC, Altenburg J, Bronsveld I, Doodeman HJ, Rozemeijer W, Heijerman HGM, Boersma WG. The BATTLE study: Effects of long-term tobramycin inhalation solution (TIS) once daily on exacerbation rate in patients with non-cystic fibrosis bronchiectasis. Study protocol of a double blind, randomized, placebo-controlled trial: study protocol. Contemp Clin Trials Commun. 2022 Dec 6;30:101045. doi: 10.1016/j.conctc.2022.101045. eCollection 2022 Dec.
PubMed 36531900Terpstra LC, Altenburg J, Bronsveld I, de Kruif MD, Berk Y, Snijders D, Rozemeijer W, Heijerman HGM, Boersma WG. Effects of long-term tobramycin inhalation solution (TIS) once daily on exacerbation rate in patients with non-cystic fibrosis bronchiectasis. Respir Res. 2022 Dec 3;23(1):330. doi: 10.1186/s12931-022-02243-y.
PubMed 36463180
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Inhaled Nebulized Tobramycin in Patients With Non-cystic Fibrosis Bronchiectasis. A Randomized Placebo Controlled Trial. The BATTLE Study Bronchiectasis And Tobramycin SoluTion InhaLation ThErapy.
- ClinicalTrials.gov ID
- NCT02657473
- Acronym / sponsor ID
- BATTLE / 54939
- Conditions
- Non-CF Bronchiectasis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Study start
- 13 Aug 2016 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 15 Jan 2016 (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.
The purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS) once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint is a reduction of exacerbations of the disease during the treatment period. Next to this parameter the investigators expect to show a significant beneficial effect on lung function parameters, QoL, bacterial load of pathogens in sputum and tobramycin resistance.
Detailed description
See uploaded study protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- . In present study the value of maintenance TIS will be investigated in patients with non-CF bronchiectasis colonized by different bacterial species sensitive for tobramycin. Objective: The primary outcome of the study is a 50% reduction in exacerbation rate in patients using maintenance TIS (OD). Secondary outcome parameters are lung function (FEV1, FVC), QoL (QOL-B), LTRI-VAS, Leicester cough score, bacterial load in sputum and tobramycin resistant pathogens. Study design: A randomised, double blind placebo controlled, multicenter study. Study population: Patients aged ≥ 18-year-old with confirmed bronchiectasis by (HR)CT and at least two exacerbations during previous 12 months.
| Arm | Type | Receives |
|---|---|---|
| TIS 300mg once daily | Active comparator | Drug: tobramycin inhalation solutionTobramycin inhalation solution (TIS) 300mg once daily for at least 9 months and up to 12 months |
| Placebo once daily | Placebo comparator | Drug: Saline 0.9% inhalation solutionSaline 0.9% inhalation solution 300mg once daily for at least 9 months and up to 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum
- Confirmed non-CF bronchiectasis by (HR)CT
- Documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics within 12 months before inclusion.
- No course of antibiotics or maintenance antibiotics (except for macrolides) 1 month prior to the start of the study.
Key exclusion criteria (16 listed)
- Any exacerbation within the month prior to the start of the study
- Diagnosis of cystic fibrosis
- Active allergic bronchopulmonary aspergillosis (ABPA)
- Any oral, IV or inhaled antibiotics (except for macrolides) within 1 month prior to the start of the study
- Any IV or IM corticosteroids or change in oral corticosteroids (> 10 mg) within 1 month prior to the start of the study
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 solution | Drug | TIS 300mg once daily |
| Saline 0.9% inhalation solution | Drug | Placebo once daily |
Primary outcome
Number of exacerbations
Time frame: 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Derived from this study: PubMed 36531900Terpstra LC, Altenburg J, Bronsveld I, Doodeman HJ, Rozemeijer W, Heijerman HGM, Boersma WG. The BATTLE study: Effects of long-term tobramycin inhalation solution (TIS) once daily on exacerbation rate in patients with non-cystic fibrosis bronchiectasis. Study protocol of a double blind, randomized, placebo-controlled trial: study protocol. Contemp Clin Trials Commun. 2022 Dec 6;30:101045. doi: 10.1016/j.conctc.2022.101045. eCollection 2022 Dec.
- Derived from this study: PubMed 36463180Terpstra LC, Altenburg J, Bronsveld I, de Kruif MD, Berk Y, Snijders D, Rozemeijer W, Heijerman HGM, Boersma WG. Effects of long-term tobramycin inhalation solution (TIS) once daily on exacerbation rate in patients with non-cystic fibrosis bronchiectasis. Respir Res. 2022 Dec 3;23(1):330. doi: 10.1186/s12931-022-02243-y.
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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.
Wim G. Boersma, Dr.MD principal investigator
Medical Center Alkmaar
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing tobramycin inhalation solution and Saline 0.9% inhalation solution in people with Non-CF Bronchiectasis, run by Medical Center Alkmaar at 6 sites in Netherlands.
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 8 inclusion and 16 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of exacerbations (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657473, which also lists 2 linked publications.
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 Dec 2019.