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Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

NCT ID: NCT02657473

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-13

Study Completion Date

2019-12-13

Brief Summary

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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

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See uploaded study protocol

Conditions

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Non-CF Bronchiectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

. 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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TIS 300mg once daily

Tobramycin inhalation solution (TIS) 300mg once daily for at least 9 months and up to 12 months

Group Type ACTIVE_COMPARATOR

tobramycin inhalation solution

Intervention Type DRUG

Placebo once daily

Saline 0.9% inhalation solution 300mg once daily for at least 9 months and up to 12 months

Group Type PLACEBO_COMPARATOR

Saline 0.9% inhalation solution

Intervention Type DRUG

Interventions

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tobramycin inhalation solution

Intervention Type DRUG

Saline 0.9% inhalation solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum
3. Confirmed non-CF bronchiectasis by (HR)CT
4. Documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics within 12 months before inclusion.
5. No course of antibiotics or maintenance antibiotics (except for macrolides) 1 month prior to the start of the study.
6. Minimal one documented sputum or BAL-fluid culture with gram-negative bacteria or S.aureus within 12 months.
7. Growth of protocol defined pathogens in sputum at screening visit sensitive to tobramycin
8. Tolerance of inhaled tobramycin

Exclusion Criteria

1. Any exacerbation within the month prior to the start of the study
2. Diagnosis of cystic fibrosis
3. Active allergic bronchopulmonary aspergillosis (ABPA)
4. Any oral, IV or inhaled antibiotics (except for macrolides) within 1 month prior to the start of the study
5. Any IV or IM corticosteroids or change in oral corticosteroids (\> 10 mg) within 1 month prior to the start of the study
6. Any change/start treatment regimens macrolides, hypertonic saline, inhaled mannitol or other mucolytics, corticosteroids within 1 month prior to the start of the study
7. Change in physiotherapy technique or schedule within 1 month prior to the start of the study
8. Severe immunosuppression or active malignancy
9. Active tuberculosis
10. Chronic renal insufficiency (eGFR \< 30 ml/min), use of loop diuretics
11. Have received an investigational drug or device within 1 month prior to the start of the study
12. Serious or active medical or psychiatric illness
13. Pregnancy and child bearing
14. History of poor cooperation or non-compliance
15. Unable to use nebulizers
16. Allergic for tobramycin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Center Alkmaar

OTHER

Sponsor Role lead

Responsible Party

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W.G.Boersma

Dr.MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wim G. Boersma, Dr.MD

Role: PRINCIPAL_INVESTIGATOR

Medical Center Alkmaar

Locations

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North West Clinics

Alkmaar, North Holland, Netherlands

Site Status

VU Medical Center

Amsterdam, , Netherlands

Site Status

Zuyderland Medisch Centrum

Heerlen, , Netherlands

Site Status

Spaarne Gasthuis

Hoofddorp, , Netherlands

Site Status

Canisius Ziekenhuis

Nijmegen, , Netherlands

Site Status

UMCU

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 36531900 (View on PubMed)

Terpstra 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.

Reference Type DERIVED
PMID: 36463180 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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54939

Identifier Type: -

Identifier Source: org_study_id