Children with obstructive sleep apnea syndrome (OSAS) who undergo treatment with intranasal corticosteroids (INCS) did not experience significant improvement in polysomnographic, neurobehavioral, and other symptoms at 3 and 12 months of treatment. At 12 months of INCS treatment, there was a statistically significant but not clinically relevant reduction in the obstructive apnea hypopnea index (OHAI).
“Previous studies were done in children with OSA with an obstructive apnea hypopnea index of less than 5, so they had very mild OSA,” Ignacio Tapia, MD, associate professor of pediatrics, University of Pennsylvania, Philadelphia, said in an interview.
“But then people started using the INCS for a whole range of OSA, so this is why we wanted to do the trial, to make sure that these drugs were being used correctly,” he added.
“The main message from this paper is that I think INCS may still have a role to play in OSA to treat some of the symptoms, like snoring, and in our study, quality of life indices also improved, ,” Dr. Tapia emphasized.
The study was published online in the journal Chest.
3 months of INCS
A total of 134 children between 5 and 12 years of age were randomly assigned to receive INCS for 3 months or placebo. Children in the original INCS arm were then reassigned to receive 9 more months of the same treatment or placebo. Symptoms as well as polysomnographic and neurobehavioral findings were measured at baseline, at 3 months, and again at 12 months.
“The primary outcome was OAHI change at 3 months, available for 122 children,” the authors explained. The OSAS was defined as an OAHI of between two and three events per hour. The median age of the children at baseline was 7.9 years, and the median OAHI baseline score was 5.8/hr (95% confidence interval, 3.6-9.7/hr). The total daily dose of the INCS used was 110 mcg.
At 3 months, the mean change in the OAHI from baseline was –1.73/hr (95% CI, –3.91 to 1.92/hr), while at 12 months, the mean change in the same index was –1.21 (–4.22 to 1.71/hr). These changes were not significantly different from OAHI changes observed among control participants. “OSAS symptoms and neurobehavioral results were not different [either] between the INCS and placebo groups at 3 and12 months,” the authors added.
However, among those children who received INCS treatment for the entire 12 months, the OAHI decreased significantly from 7.2/hr (95% CI, 3.62-9.88/hr) at baseline to 3.71/hr (95% CI, 1.56-6.4/hr; P = .039), although the OAHI did not normalize, the authors noted. Asked to clarify whether this change was not significant, Dr. Tapia said that it did meet statistical significance, but clinically, it meant that the children still needed some form of treatment, because they still had OSA in the range needing treatment.
The placebo group had more asthma exacerbations, upper respiratory tract infections, and exacerbations of OSAS symptoms, compared with children in the INCS group. It is possible that INCS provided a certain degree of protection from asthma exacerbation, the authors suggested.
However, recent guidelines from the American Academy of Pediatrics suggest that clinicians may prescribe these agents for children with mild OSAS in whom adenotonsillectomy is contraindicated; for those with mild postoperative OSAS, adenotonsillectomy remains the treatment of choice for childhood OSA. “The low level of enthusiasm for INCS in these guidelines is based on results from studies of INCS treatment of OSAS that had been limited by small sample size, lack of placebo control, limited duration, and variability in baseline data,” the authors wrote.
“The results of the current larger and more rigorous study of children with a wider range of OSAS also do not support the currently liberal use of INCS for the treatment of OSAS,” they wrote.