Primary objectives1. Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis?2. Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )?…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction in number exacerbations.
Definition of exacerbation: increase in dyspnoea, coughing, and sputum
production for which a course of prednisolone and/or antibiotic is needed.
Change in lung function parameters measured by spirometry: FEV1 (L), FVC (L).
Secondary outcome
Symptomscore. A number of symptoms will be measured on a Visual Analogue Scale
(LRTI-VAS) (Appendix 2)
Bacterial coloniation. Sputum samples will be cultures. The isolated bacteria
will be quantified.
Inflammatory markers.
Sputum: MPO, ECO, elastase, IL-1-α of IL-1β, IL-6, IL-8, TNF-α, MMP*s.
Serum: CRP, procalcitonine, Il-6, IL-8, TNF-α.
Quality of life.
Change in quality of life will be measured by St. George*s Respiratory
Questionnaire (SGRQ).
Background summary
Rationale: Patients with bronchiectasis often experience lower respiratory
tract infections with progression of symptoms and decline in quality of life.
Macrolides, as has been shown in panbronchiolitis and cystic fibrosis, may
break or weaken the link between infection and inflammation resulting in an
improvement of symptoms. Also the number of exacerbations may lowered.
Objective: A reduction in number of infective exacerbations and improvement in
longfunction by AZT treatment are the primary objectives. Secondary objectives
that will be evaluated are: symptoms score, quality of life, inflammatory
parameters, bacterial colonisation, and adverse events.
Study design: Randomised double blind multicenter study in the Netherlands.
Patients will be stratified for colonisation with P.aeruginosa.
Study population: Patients with bronchiectasis demonstrated by HR-CT scan or
bronchography.
Intervention: Patients receive AZT 500 mg p.o. every other day or placebo.
Main study parameters/endpoints: Reduction in number exacerbations, definied
as increase symptoms such as dyspnoea, coughing, and sputum production for
which a course of prednisolone and/or antibiotic is needed. Change in lung
function parameters (FEV1, FVC) measured by spirometry is the other primairy
endpoint.
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The risk of participating in this study is low.
Laboratory, radiographic examinations, and pulmonary function tests are
commonly used as diagnostic procedures during outpatients visits and during
exacerbations. Adverse effects in maintance treatment with AZT are usually mild
and mainly gastrointestinal. Sometimes rash and abnormal liver function tests
are observed. A better quality of life will probably the beneficial effect of
long term treatment with AZT. This will be achieved by a reduction in
respiratory and non-respiratory symptoms and number of exacerbations
Study objective
Primary objectives
1. Does prolonged antibiotic treatment with AZM reduce the number of bacterial
exacerbations in patients with bronchiectasis?
2. Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )?
Secondary objectives
1. Is there any improvement in symptom score during treatment with AZM?
2. What is the effect of AZM on bacterial colonisation?
3. Does treament with AZM reduce inflammatory parameters?
4. Does treatment with AZM change the quality of life?
5. Is there any differences in adverse events between AZM en placebo treatment?
Study design
Randomised double blind multicenter study in the Netherlands. Patients will be
stratified for colonisation with P.aeruginosa.
Intervention
AZM tablet 500 mg every other day versus placebo 500mg
Study burden and risks
Minimal risk: chance of mild adverse effects
Some extra visits to outpatient ward
Postbus 501
1800AM Alkmaar
NL
Postbus 501
1800AM Alkmaar
NL
Listed location countries
Age
Inclusion criteria
•Patients aged 18 >= years
•Bronchiectasis diagnosed by plain bronchography or high resolution computer tomography.
•Minimal 4 lower respiratory tract infection (LRTI) treated with oral/IV antibiotics in the year preceeding the study inclusion.
•The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum.
•Three sputum cultures with either P.aeruginosa or H. influenzae in the preceeding year.
•Informed consent.
Exclusion criteria
•Previous ( >= 6 weeks) prolonged macrolide therapy.
•Pregnant or lactating women.
•Allergy to macrolides.
•Intolerance to macrolides.
•Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or
more times the upper limit of normal).
•Use of antibiotics within 14 days of screening.
•Use of orale or IV corticosteroids (>= 30 mg prednisolone/daily) within 30 days
of screening.
•Initiation of tobramycin/colimycin solution for inhalation, recombinant
human DNAase inhalation solution, or high dose ibuprofen within 30 dagen
of screening.
•Other research medication started 2 months prior to inclusion.
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 | EUCTR2007-000001-30-NL |
| ClinicalTrials.gov | NCT00415350 |
| CCMO | NL16025.094.07 |