Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronc... | NCT02657473

Studies
Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

NCT02657473

Sponsor

Medical Center Alkmaar

Status

Completed

Last Update Posted

Dec 17, 2019Actual

Enrollment

58Actual

Phase

Phase 2Phase 3

Conditions

Non-CF Bronchiectasis

Interventions

tobramycin inhalation solution
Saline 0.9% inhalation solution

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 13, 2016Actual

Primary Completion Date

Dec 13, 2019Actual

Completion Date

Dec 13, 2019Actual

First Submitted Date

Jan 13, 2016

First Submission Date that Met QC Criteria

Jan 13, 2016

First Posted Date

Jan 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2019

Last Update Posted Date

Dec 17, 2019Actual

Description Module

Brief 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. 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TIS 300mg once daily	Active Comparator	Tobramycin inhalation solution (TIS) 300mg once daily for at least 9 months and up to 12 months	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	Drug: Saline 0.9% inhalation solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tobramycin inhalation solution	Drug		TIS 300mg once daily
Saline 0.9% inhalation solution

Measure	Description	Time Frame
Number of exacerbations		13 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Wim G. Boersma, Dr.MD	Medical Center Alkmaar	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
North West Clinics		Alkmaar	North Holland	1815JD	Netherlands
VU Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36531900	Derived	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.
36463180

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals