- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02657473
Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis (BATTLE)
December 13, 2019 updated by: W.G.Boersma, Medical Center Alkmaar
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
See uploaded study protocol
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amsterdam, Netherlands
- VU Medical Center
-
Heerlen, Netherlands
- Zuyderland Medisch Centrum
-
Hoofddorp, Netherlands
- Spaarne Gasthuis
-
Nijmegen, Netherlands
- Canisius Ziekenhuis
-
Utrecht, Netherlands
- UMCU
-
-
Noord-Holland
-
Alkmaar, Noord-Holland, Netherlands, 1815JD
- North West Clinics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TIS 300mg once daily
Tobramycin inhalation solution (TIS) 300mg once daily for at least 9 months and up to 12 months
|
|
Placebo Comparator: Placebo once daily
Saline 0.9% inhalation solution 300mg once daily for at least 9 months and up to 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of exacerbations
Time Frame: 13 months
|
13 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wim G. Boersma, Dr.MD, Medical Center Alkmaar
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 13, 2016
Primary Completion (Actual)
December 13, 2019
Study Completion (Actual)
December 13, 2019
Study Registration Dates
First Submitted
January 13, 2016
First Submitted That Met QC Criteria
January 13, 2016
First Posted (Estimate)
January 15, 2016
Study Record Updates
Last Update Posted (Actual)
December 17, 2019
Last Update Submitted That Met QC Criteria
December 13, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 54939
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-CF Bronchiectasis
-
COPD FoundationRecruitingNon-CF Bronchiectasis | Nontuberculosis Mycobacteria (NTM)United States
-
Children's Hospital Medical Center, CincinnatiRecruitingCystic Fibrosis | Non-CF BronchiectasisUnited States
-
Heba OmaraCompletedCystic Fibrosis and Non CF BronchiectasisEgypt
-
University of North Carolina, Chapel HillCystic Fibrosis FoundationNot yet recruiting
-
Renovion, Inc.CompletedNon-cystic Fibrosis BronchiectasisUnited States
-
Qilu Hospital of Shandong UniversityCompletedNon-Cystic Fibrosis BronchiectasisChina
-
Papworth Hospital NHS Foundation TrustLifeArcNot yet recruitingNon-cystic Fibrosis BronchiectasisUnited Kingdom
-
The University of Hong KongRecruiting
-
The University of Hong KongCompleted
-
Universitaire Ziekenhuizen KU LeuvenCompleted
Clinical Trials on tobramycin inhalation solution
-
Erik Allen JensenUniversity of FloridaRecruiting
-
Novartis PharmaceuticalsCompletedCystic FibrosisUnited States, Germany, United Kingdom, Colombia, Spain, France, Netherlands, Israel, Canada, Italy, Chile, Australia, Hungary, Mexico
-
Novartis PharmaceuticalsCompletedCystic FibrosisSpain, Germany, Switzerland, United Kingdom, Ireland
-
Qianfoshan HospitalActive, not recruitingBronchiectasis | Cystic Fibrosis | Lung InfectionChina
-
Gilead SciencesCovance; ClinPhone, Inc.; Chiltern International Inc.CompletedCystic FibrosisBelgium, France, Germany, Italy, Netherlands, Spain, United States, Ireland, United Kingdom, Portugal, Austria, Denmark, Switzerland
-
NovartisCompleted
-
Novartis PharmaceuticalsCompleted
-
Respirion Pharmaceuticals Pty LtdRecruitingPseudomonas Aeruginosa | Cystic Fibrosis Lung | Respiratory Infections, Recurrent, ChronicUnited States, Australia
-
Bonnie RamseyNational Heart, Lung, and Blood Institute (NHLBI)CompletedCystic FibrosisUnited States
-
Gilead SciencesCompleted