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| Name | Class |
|---|---|
| Sociedad Valenciana de NeumologĂa | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | without azithromycin | |
| azithromycin | Active Comparator | treatment with azithromycin during three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | 250 mg three times a week during three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Nitric oxide,8-isoprostane, pH, nitrites (NO2) and nitrates(NO3) in exhaled breath condensate. | 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. | Before and after three months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Exacerbations | exacerbations was defined by hospital admissions or antibiotics prescription | Before and after three months of treatment |
| changes in lung function | Changes in FEV1, FVC. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo De Diego Damia, MD | Instituto InvestigaciĂ³n Sanitaria La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital La Fe | Valencia | 46026 | Spain |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D000359 | Aftercare |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Before and after three months of treatment |
| colour and volume sputum, | 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 | Before and after three months of treatment |
| Impact on functional capacity and health related quality of life | 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) | Before and after three months of treatment |
| Changes in HRCT Lung scores | Standard lung HRCT scan was performed to quantify the extension of bronchiectasis | Before and after three months of treatment |
| Organic Chemicals |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |