The primary outcome of the study is a 50% reduction in exacerbation rate in patients using TIS once daily (OD). Secondary outcome parameters are lung function (FEV1, FVC), QoL (QOL-B), LTRI-VAS, Leicester cough score), bacterial load in sputum and…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a reduction of exacerbations that patients suffer
during the treatment period.
Secondary outcome
Next to this parameter we expect to show a significant beneficial effect on
lung function parameters, QoL, bacterial load of pathogens in sputum and
tobramycin resistance.
Background summary
Patients with bronchiectasis often have exacerbations of their disease. These
exacerbations influence the quality of life. In patients with cystic fibrosis
(CF) inhaled antibiotics lower the bacterial load in bronchial secretions and
have positive effect on the number of exacerbations, lung function and quality
of life (QoL). In patients with non-CF bronchiectasis colonized with
Pseudomonas aeruginosa studies with tobramycin inhalation solution (TIS) are
limited, however with only five trials to date. In present study the value of
TIS will be investigated in patients with non-CF bronchiectasis colonized by
different bacterial species sensitive for tobramycin.
Study objective
The primary outcome of the study is a 50% reduction in exacerbation rate in
patients using TIS once daily (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, placebo controlled, multicentre study
Intervention
During the study each group (placebo, intervention) receives TIS or placebo,
once daily 300mg for a period of 12 months.
Study burden and risks
After informed consent patients have 3 monthly visits. During the visits
patients have to deliver a sputum sample, fill in the QoL questionnaires and
spirometry will be performed according the study schedule. Also a blood sample
will be taken during a number of visits. All patients are instructed to use the
nebulizer adequately. The whole procedure of TIS (preparation, inhalation and
cleaning) takes approximately 15 minutes. Adverse effects consist of cough,
wheezing and dyspnoea. In general practice salbutamol is used, before
nebulizing TIS, to relieve these symptoms. TIS has already been used by a
number of patients with bronchiectasis and is well tolerated. Safety of TIS
will be assessed during each contact.
wilhelminalaan 12
Alkmaar 1815JD
NL
wilhelminalaan 12
Alkmaar 1815JD
NL
Listed location countries
Age
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 and/or prednisolone 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 sensitive to tobramycin at screening visit
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. Severe immunosuppression or active malignancy
8. Active tuberculosis
9. Chronic renal insufficiency (eGFR < 30 ml/min)
10. Have received an investigational drug or device within 1 month prior to the start of the study
11. Serious or active medical or psychiatric illness
12. Pregnancy and child bearing
13. History of poor cooperation or non-compliance
14. Unable to use nebulizers
15. Allergic for tobramycin or NaCl 0.9%
16. Use of diuretics, urea or mannitol
17. Demonstrated heraring impairment, balance disorders or neuromuscular disorders
18. Serious active haemoptysis
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-000166-35-NL |
| ClinicalTrials.gov | NCT02657473 |
| CCMO | NL54939.094.16 |