Table 2.
Aerosol studies with aztreonam lysinate
| Reference | Drug | Subjects | Production system | Result | Dosage | LFTs | Major adverse effects |
|---|---|---|---|---|---|---|---|
| Gibson et al34 | Aztreonam lysinate | 21 adults and 19 adolescents | eFLOW nebulizer system (PARI) | Efficient drug evaluation, increased sputum and plasma drug levels after inhalation | 75 mg/150 mg 225 mg |
FEV1, FVC, FEF25–75 SaO2 | Chest tightness, increased sputum, nasal congestion, aggravated cough, 1 patient >20% FEV1 reduction |
| Retsch-Bogart et al35 | Aztreonam lysinate | 105 randomized 14 days | eFLOW nebulizer system (PARI) | Decrease in sputum PA density, increase in FEV1 for AZLI patients in 7 days | 75 mg/225 mg/twice daily placebo | FEV1, FVC, FEF25–75<br/>SaO2 | Cough, transient decrease in FEV1 |
| Retsch-Bogart et al36 | Aztreonam lysinate | ≥6 years 124 completed |
eFLOW nebulizer system (PARI) | CFQ-R-respiratory scores improved and FEV1 improved, weight gain | 75 mg/28 days | FEV1 | Pulmonary exacerbation |
| Oermann et al38 | Aztreonam lysinate | ≥6 years, 195 completed Mean age 28.5 years |
eFLOW nebulizer system | CFQ-R and FEV1 increase, reduction of sputum PA density | 75 mg twice or three times daily, 18 months | FEV1, FVC, FEF25–75 | Pyrexia, fatigue, headache, cough, decreased appetite |
| Oermann et al39 | Aztreonam lysinate | ≥6 years, 195 completed Mean age 28.5 years |
eFLOW nebulizer system | 30% increase in MIC, increase in tobramycin susceptibility | 75 mg twice or three times daily, 18 months | – | – |
| Wainwright et al40 | Aztreonam lysinate | ≥6 years 157 patients |
eFLOW nebulizer system | CFQ-R and FEV, increase, reduction of sputum PA density | 75 mg three times daily, 28 days | FEV1 | 3 patients discontinued due to pulmonary exacerbation, one patient >20% FEV1 reduction |
| Parkins et al68 | AZLI | Review | Review | Review | Review | Review | Review |
Abbreviations: FEV1, forced expiratory volume in one second; FVC, forced vital capacity; FEF25–75, forced expiratory flow during middle half of forced vital capacity; SaO2, oxygen saturation; CFQ-R, Cystic Fibrosis Questionnaire-Revised; TOBI, inhaled tobramycin solution; AZLI, aztreonam lysinate; PA, Pseudomonas aeruginosa; MIC, minimum inhibitory concentration; LFTs, lung function tests.