Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

NCT02657473 | Completed Phase 2

• 1 other identifier: 54939
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 6

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.

Conditions

Non-CF Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Number of exacerbations

  13 months

Study Arms (2)

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

tobramycin inhalation solution DRUG

TIS 300mg once daily

Saline 0.9% inhalation solution DRUG

Placebo once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum
• Confirmed non-CF bronchiectasis by (HR)CT
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Center Alkmaar: lead

Study Sites (6)

North West Clinics

Alkmaar, North Holland, 1815JD, Netherlands

Location

VU Medical Center

Amsterdam, Netherlands

Location

Zuyderland Medisch Centrum

Heerlen, Netherlands

Location

Spaarne Gasthuis

Hoofddorp, Netherlands

Location

Canisius Ziekenhuis

Nijmegen, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 36531900 DERIVED

• 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.

  PMID: 36463180 DERIVED

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Wim G. Boersma, Dr.MD

  Medical Center Alkmaar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.MD.

Model Details: . 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.

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 15, 2016
• Study Start: August 13, 2016
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

NL (6)