Randomized, triple-blind, placebo-controlled, parallel-group trial
of nasal fluticasone for the treatment of obstructive sleep apnea
in 25 children aged 1-10 years.1
criteria included (1) Adenoidal hypertrophy (2) Signs and symptoms
of OSA (3) AHI > 1 on polysomnography (PSG).
excluded if any of the following were present: craniofacial abnormalities,
genetic abnormalities, Down's syndrome, neurologic disease, acute
URI, severe OSA requiring urgent surgery, 4+ tonsillar hypertrophy,
exposure to varicella, use of systemic steroids or antibiotics
within last 3 weeks.
underwent PSG, 44 eligible for study, only 25 (57%) completed
in treatment group received fluticasone propionate 1 spray per
nostril twice daily for 6 weeks.
patients underwent PSG before and after treatment/placebo.
group had decrease in AHI from 10.7 ± 2.6 to 5.8 ±
2.2 compared with placebo, who went from10.9 ± 2.3 to13.1
± 3.6 (p=0.04).
of desaturations decreased by 4/hr (p=0.03) and arousals/movements
decreased by 3.5/hr (p=0.05).
of patients in treatment group went on to adenotonsillectomy compared
to 75% of those patients in placebo group.
of tonsils and adenoids did not decrease with treatment.
score did not improve with treatment.
was valid in that it was randomized and triple-blinded. Groups
were treated equally. However, differences in the baseline characteristics
of the two different groups were significant.