Inhaled hydrofluoalkane-beclomethasone dipropionate in bronchopulmonary dysplasia. A double-blind, randomized,...

Area of Science:

• Neonatology
• Pediatric Pulmonology
• Pharmacology

Background:

• Bronchopulmonary dysplasia (BPD) is a chronic lung disease in preterm infants.
• The efficacy of inhaled corticosteroids for established BPD remains uncertain.
• Hydrofluoalkane-beclomethasone dipropionate (QVAR) has a small particle size, potentially increasing lung deposition.

Purpose of the Study:

• To determine if inhaled QVAR reduces respiratory rehospitalizations in infants with established BPD.
• To assess the safety and efficacy of QVAR in this population.

Main Methods:

• A double-blind, randomized, placebo-controlled, multicenter pilot study.
• Inclusion of preterm infants with moderate-to-severe BPD.
• Administration of inhaled QVAR (100 μg/dose) or placebo twice daily via Aerochamber with face mask from 36 weeks postmenstrual age until 3 months post-discharge.

Main Results:

• Groups were comparable in baseline characteristics, length of stay, and oxygen requirements.
• Respiratory rehospitalizations and associated days tended to be lower in the QVAR group, but differences were not statistically significant.
• No significant differences were observed in blood pressure, growth, or urine cortisol/creatinine ratio between groups.

Conclusions:

• This pilot study did not detect a significant effect of inhaled QVAR on the respiratory course of established BPD.
• The study was underpowered to detect potential benefits.
• Higher use of additional steroids in the placebo group may have masked possible QVAR benefits.