CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Chest physiotherapy during anesthesia for children with cystic fibrosis: effects on respiratory function.

Study design (if review, criteria of inclusion for studies)

double-blind, multicenter, randomized, placebo-controlled trial

Participants

CF patients (≥6 years) with FEV(1)>75% predicted.

Interventions

AZLI 75 mg (n=76) or placebo (n=81) was administered 3-times daily for 28days with a 14-day follow-up.

Outcome measures

CFQ-R-Respiratory Symptoms Scale (primary endpoint); sputum PA colony-forming units, FEV(1)% predicted

Main results

Day 28 treatment effects were 1.8points for CFQ-R-Respiratory Symptoms Scale (95%CI: -2.8, 6.4; p=0.443; primary endpoint); -1.2 for log(10) sputum PA colony-forming units (p=0.016; favoring AZLI), and 2.7% for relative FEV(1)% predicted (p=0.021; favoring AZLI). Treatment effects favoring AZLI were larger for patients with baseline FEV(1) <90% predicted compared to ≥90% predicted. AZLI was well-tolerated.

Authors' conclusions

Effects on respiratory symptoms were modest; however, FEV(1) improvements and bacterial density reductions support a possible role for AZLI in these relatively healthy patients.

Keywords: Adult; Aged; Anti-Bacterial Agents; Aztreonam; Bacterial Infections; Child; Infection; Inhalation OR nebulised; pharmacological_intervention; placebo; Pseudomonas aeruginosa; Pseudomonas; Respiratory Tract Diseases; Respiratory Tract Infections; Monobactams;