A randomized, double-blind, placebo-controlled trial on the effect of intranasal corticosteroid as a treatment for moderate to severe obstructive sleep apnea with coexisting chronic rhinitis
Vorakamol Phoophiboon,1,2 Kiat Ruxrungtham,3,4 Dittapol Muntham,5 Naricha Chirakalwasan1,2
Affiliations:
1 Division of Pulmonary and Critical Care medicine, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
2 Excellence Center for Sleep Disorders, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand
3 Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine Chulalongkorn University, Bangkok, Thailand
4 Chula VRC, Faculty of Medicine, Chulalongkorn University
5 Section for Mathematics, Faculty of Science and Technology, Rajamangala University of Technology Suvarnabhumi, Phranakhon Si Ayutthaya, Thailand
Abstract
Background: Chronic rhinitis is a common co-existing disease with obstructive sleep apnea (OSA). Current evidence on intranasal steroid efficacy as a treatment modality is scarce.
Objective: This study assessed the efficacy of intranasal steroid in moderate to severe OSA with coexisting chronic rhinitis.
Methods: A prospective randomized, double-blind, placebo-controlled trial was conducted in non-2nd to 3rd degree obese, non-severe oropharyngeal obstruction, moderate to severe OSA with coexisting chronic rhinitis (total nasal symptom score (TNSS) ≥ 6, BMI < 30 kg/m2, modified Mallampati < 3). We randomized the patients to receive intranasal steroid (fluticasone furoate, 110 mcg/day) or placebo for one-month duration. The primary end point was the change in apnea hypopnea index (AHI).
Results: A total of 34 patients were randomly assigned to receive intranasal steroid (N = 18) or placebo (N = 16). The
adjusted absolute difference mean change of AHI did not show significant difference (11.5 ± 7.9 events/hour [95% CI; -4.9 to 27.8; p = 0.16]). Interestingly, significant reduction in non-supine respiratory disturbance index (RDI) (56.1 ± 21.9 events/hour [95% CI; 18.9 to 93.2; p = 0.01]) was observed in intranasal steroid group. When comparison was made within group, only intranasal steroid group demonstrated significant reduction in AHI, RDI, NREM RDI, TNSS, and Thai Pittsburgh sleep quality index (p = 0.02, 0.02, 0.01, 0.003, and < 0.001; respectively) after receiving the drug.
Conclusion: In moderate to severe OSA patients with coexisting chronic rhinitis, intranasal steroid demonstrated significant reduction in obstructive respiratory events during non-supine sleep. Intranasal steroid may be considered as adjunctive or alternative to OSA treatment.
Key words: obstructive sleep apnea, chronic rhinitis, intranasal corticosteroid, positional therapy, oral appliance