Effect of nebulized Azithromycin in cystic fibrosis disease
- Conditions
- Cystic fibrosis.Cystic fibrosis with pulmonary manifestations
- Registration Number
- IRCT2016100930233N1
- Lead Sponsor
- Vice chancellor for research,Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Patients enrolled into the study were: 8 to18 years old with a
documented CF diagnosis (sweat tests more than 60 mEq/L at least two times) and had moderate-to-severe lung disease (FEV1 _ 25% to _ 75% predicted) and PA airway infection (documented at screening or two times within previous year; including once within the previous 3 months) not recent (ie, day _28 to screening) administration of inhaled, IV, or oral antipseudomonal antibiotics, not administration of oral Azithromycin at least for two months ( 2 months wash out or has not administered yet or stop taking oral Azithromycin at least for 2 months ).
Exclusion criteria: current oral corticosteroid, lung transplantation;
recent changes in antimicrobial, bronchodilator, antiinflammatory,
or corticosteroid medications, or physiotherapy technique/
schedule; smear-positive sputum for non- Mycobacterium tuberculosis.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pseudomonas aeruginosa colony count. Timepoint: screening, Baseline,+28 day Treatment. Method of measurement: sputum Test and culture.;FEV1. Timepoint: screening, Baseline,+28 day Treatment. Method of measurement: spirometry.;Pseudomonas aeruginosa phenotype. Timepoint: Screeninig, Baseline,+28 day Treatment. Method of measurement: sputum Test and culture.;Pseudomonas aeruginosa resistance pattern. Timepoint: Screeninig, Baseline,+28 day Treatment. Method of measurement: sputum Test and culture.
- Secondary Outcome Measures
Name Time Method