Cystic fibrosis. Cystic fibrosis with pulmonary manifestations
Conditions
Interventions
Intervention 1: In treatment group patients assigned to 28 days of treatment with 70 mg of nebulized AZT. Intervention 2: In control group patients assigned to 28 days of treatment with oral AZT every
Treatment - Drugs
In treatment group patients assigned to 28 days of treatment with 70 mg of nebulized AZT
In control group patients assigned to 28 days of treatment with oral AZT every other day (250 mg for weight less than 40 kg and 500 mg for weight more than 40 kg).
Sponsors
Vice chancellor for research,Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Andisheh Maneshi
Children Medical Center
Outcome results
None listed