Fluticasone furoate nasal spray slows growth velocity in young children
Published Online: May 23, 2014
Nasal steroid sprays are very effective treatments for patients with allergic rhinitis (AR or hay fever). However, it is known that steroid sprays may slow growth in children, and clinicians are advised to monitor growth in children for whom steroid sprays are prescribed. Studies with different intranasal steroid sprays have measured a growth rate between 0.9 cm and 0.2 cm slower during one year of treatment. However, in some studies, growth rates in children receiving a steroid spray were not clearly different compared with those who received placebo, perhaps due to methodological differences in the studies or ages of the children.
In a study recently published in The Journal of Allergy and Clinical Immunology: In Practice, Lee and colleagues precisely measured growth rates in children between 5 and 8 years of age when they were treated with fluticasone furoate nasal spray, receiving 110 mcg daily (2 sprays each nostril) for one year, compared to placebo. These children were allergic to year-round allergens such as pets or house dust mites and had moderate allergy symptoms (a score of 5 out of 12 for nasal itching, sneezing, drainage and congestion). The children had their height measured every month for four months before starting treatment, during the year of treatment, and for two months after treatment. Every day they also electronically recorded a score for their nasal symptoms and if they took their study medication. As this was a long term placebo controlled study, the children were also able to take an allergy medication by mouth (loratidine) on an as needed basis.
474 children participated in the study; half of them received fluticasone furoate nasal spray and the other half received placebo. Their mean age was 6.2 years. Growth rates were reduced on average by 0.27 cm (as much as 0.48 cm and as little as 0.06 cm) in children treated with fluticasone furoate nasal spray compared to placebo. Nasal symptoms improved in both the patients receiving fluticasone furoate nasal spray and those receiving placebo, though slightly more in those receiving the nasal spray.
The investigators conclude that growth was slower in young children treated with fluticasone furoate nasal spray every day for one year. The reduction in nasal symptoms supports that subjects were compliant with their study treatments. The treatment difference in nasal symptoms compared with placebo was smaller than in other studies designed to measure efficacy of fluticasone furoate nasal spray, probably because rescue medication was also allowed to be used. The study supports general practice guidelines for clinicians to discuss potential risks of steroid treatment with their patients or caregivers, to monitor growth in children, and to use the lowest effective dose to control symptoms. The dosage used in this study was 110 mcg daily (2 sprays in each nostril). The recommended starting dosage of fluticasone furoate nasal spray in children is 55 mcg once daily (1 spray in each nostril), increasing to 2 sprays in each nostril daily for children not adequately responding and reducing once symptoms have been controlled.
The main difference between this study and other nasal steroid studies evaluating growth is the large sample size and the narrow age range of the patients studied. Over 400 subjects participated in this study compared to approximately 100-200 subjects in other studies, allowing the authors to detect a small difference in growth and to conclude that the difference was a real effect of the study treatment. As growth rates vary quite a bit depending on the age of the child, genetic makeup, nutrition, medical conditions, and their treatments other than for AR, the clinician is best positioned to determine the likely benefits and risks of a potential therapy. To facilitate this decision-making process and discussions with caregivers, this fluticasone furoate nasal spray study clearly defines a range of growth suppression that a young child may experience after a year of continuous treatment at the highest prescribed dose: on average 0.27 cm (1/8th of an inch), with a range of effects up to 0.48 cm (3/16th of an inch) or as little as 0.06 cm (1/32nd of an inch). This risk should be balanced with the potential benefit of reducing nasal allergy symptoms.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.