Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

Phase 2

Completed

• Conditions: Non-CF Bronchiectasis
• Interventions: Drug: Saline 0.9% inhalation solution; Drug: tobramycin inhalation solution

• Registration Number: NCT02657473
• Lead Sponsor: Medical Center Alkmaar

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

Study Timeline

• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Study Start: 2016-08-13
• Status Verified: 2019-12
• Primary Completion: 2019-12-13
• Study Completion: 2019-12-13
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo once daily	Saline 0.9% inhalation solution	Saline 0.9% inhalation solution 300mg once daily for at least 9 months and up to 12 months
TIS 300mg once daily	tobramycin inhalation solution	Tobramycin inhalation solution (TIS) 300mg once daily for at least 9 months and up to 12 months

Primary Outcome Measures

Name	Time	Method
Number of exacerbations	13 months

Trial Locations

Locations (6)

VU Medical Center; 🇳🇱 Amsterdam, Netherlands

North West Clinics; 🇳🇱 Alkmaar, Noord-Holland, Netherlands

Spaarne Gasthuis; 🇳🇱 Hoofddorp, Netherlands

Zuyderland Medisch Centrum; 🇳🇱 Heerlen, Netherlands

Canisius Ziekenhuis; 🇳🇱 Nijmegen, Netherlands

UMCU; 🇳🇱 Utrecht, Netherlands