Bronchiectasis
Conditions
Keywords
Bronchiectasis, Oxidative stress markers, Airway inflammation
Brief summary
The mechanism by which macrolide antibiotics have immune modifying effects independent from its antibacterial activity has not been well established. In the present work, the investigators will analyze the effect of long-term treatment with azithromycin (250 mg three times per week during three months) on airway oxidative stress markers in exhaled breath condensate of adult patients with stable non-CF bronchiectasis.
Detailed description
The mechanism by which macrolide antibiotics have immune modifying effects independent from its antibacterial activity has not been well established. In the present work, we will analyze the effect of long-term treatment with azithromycin (AZ) on airway oxidative stress markers in exhaled breath condensate of adult patients with stable non-CF bronchiectasis. Patients will be randomized in an open label model to receive AZ 250 mg three times per week during three months or nothing.Dyspnea (Borg scale), exacerbations (Nº) in the last three months, sputum volume (cc), sputum colour (15-point scale), and health related quality of life (Questionnaire St.George) will be measured in both groups before and after treatment. Lung function, sputum culture, CT scan (Bhalla score) and inflammatory markers in blood (ESR, PCR),exhaled air (Nitric Oxide,) and exhaled condensed air (pH, nitrites, isoprostane) will be assessed before and after treatment. Relationships between clinical and inflammatory markers will be studied
Interventions
DRUGAzithromycin
250 mg three times a week during three months
Sponsors
Sociedad Valenciana de Neumología
Instituto de Investigacion Sanitaria La Fe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Previous diagnosis of bronchiectasis based on lung HRCT and clinical symptoms * Clinically stable in previous four weeks without exacerbations * Informed consent
Exclusion criteria
* Bronchiectasis secondary to Cystic fibrosis, pulmonary surgical processes, immune deficiency, emphysema, allergic bronchopulmonary aspergillosis or diffuse interstitial pulmonary diseases * Intolerance to macrolides or severe liver disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Nitric oxide,8-isoprostane, pH, nitrites (NO2) and nitrates(NO3) in exhaled breath condensate. | Before and after three months of treatment | Oxidative stress and NO metabolism in airway were investigated by measuring pH and the concentration of 8-isoprostane, nitrites (NO2-) and nitrates (NO3-) in EBC. Exhaled NO was also determined in all patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Exacerbations | Before and after three months of treatment | exacerbations was defined by hospital admissions or antibiotics prescription |
| changes in lung function | Before and after three months of treatment | Changes in FEV1, FVC. |
| colour and volume sputum, | Before and after three months of treatment | In order to analyze sputum characteristics, three sterile containers were given to collect all sputum produced during three consecutive days. The average of the three days was calculated and expressed in mL/day. Sputum colour was scored using a scale developed and validated in our laboratory, which ranged from zero to fifteen: transparent (0), white (1), progressive intensities of yellow (2-7), green (8-10) and brown (10-15). Colour scores were decided after agreement between two investigators |
| Impact on functional capacity and health related quality of life | Before and after three months of treatment | The impact on functional capacity and patient´s daily life was evaluated with the Medical Research Council Dyspnea scale (MRC) and the Spanish version of the Saint George's respiratory questionnaire of quality of life (SGRQ) |
| Changes in HRCT Lung scores | Before and after three months of treatment | Standard lung HRCT scan was performed to quantify the extension of bronchiectasis |
Countries
Spain
Outcome results
None listed