A comparison of beclomethasone aqueous spray and aerosol delivery system in nasal polyps: A randomized control trial

Document Type : Original Article

Authors

Department of Otolaryngology, School of Medicine, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran

Abstract

Background: Considering the effect of beclomethasone on allergic rhinitis or nasal polyps, it has been attempted to find the best method of using this drug to have the maximum effect and increase the patients' satisfaction. Therefore, the aim of this study was to compare the efficacy of beclomethasone aerosol and aqueous nasal sprays in the patients with nasal polyps. Materials and Methods: This double-blind randomized clinical trial was conducted on 60 patients with nasal polyps. The patients were divided into two groups. The first group (beclomethasone dipropionate aqueous [BD-AQ] group) was treated with daily two puffs of beclomethasone aqueous nasal spray 50 μg in each nostril, and the second group (beclomethasone dipropionate aerosol [BD-A] group) was treated with two puffs of aerosol beclomethasone 50 μg in each nostril daily for 6 months. At the beginning of the study, the sino-nasal outcome test-22 (SNOT-22) and Lund-Mackay scores were recorded after the evaluation of disease status and the severity of symptoms. Results: The results of this study demonstrated that the mean changes in Lund-Mackay and SNOT-22 scores (83 ± 6.30 and 4.25 ± 31.60, respectively) in the BD-A group were significantly higher than the BD-AQ group (2.01 ± 3.87and 9.83 ± 24.13, respectively) (P < 0.05), but there was no significant difference in the patients' satisfaction between the two groups (P > 0.05). Conclusion: According to the results of this study, patients with nasal polyps showed a significant improvement following both the interventions, but the disease severity in the BD-A group was significantly higher than the BD-AQ group based on the mean values of Lund-Mackay score.

Keywords

1.
Small P, Kim H. Allergic rhinitis. Allergy Asthma Clin Immunol 2011;7 Suppl 1:S3.  Back to cited text no. 1
    
2.
Dykewicz MS, Hamilos DL. Rhinitis and sinusitis. J Allergy Clin Immunol 2010;125:S103-15.  Back to cited text no. 2
    
3.
Stevens WW, Schleimer RP, Kern RC. Chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol Pract 2016;4:565-72.  Back to cited text no. 3
    
4.
Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology 2012;50:1-2.  Back to cited text no. 4
    
5.
Steinke JW, Payne SC, Chen PG, Negri J, Stelow EB, Borish L. Etiology of nasal polyps in cystic fibrosis: Not a unimodal disease. Ann Otol Rhinol Laryngol 2012;121:579-86.  Back to cited text no. 5
    
6.
Batra PS, Tong L, Citardi MJ. Analysis of comorbidities and objective parameters in refractory chronic rhinosinusitis. Laryngoscope 2013;123 Suppl 7:S1-11.  Back to cited text no. 6
    
7.
Peters AT, Spector S, Hsu J, Hamilos DL, Baroody FM, Chandra RK, et al. Diagnosis and management of rhinosinusitis: A practice parameter update. Ann Allergy Asthma Immunol 2014;113:347-85.  Back to cited text no. 7
    
8.
Fokkens W, Reitsma S. New delivery forms of nasal corticosteroids. J Allergy Clin Immunol 2019;143:87-8.  Back to cited text no. 8
    
9.
Chong LY, Head K, Hopkins C, Philpott C, Schilder AG, Burton MJ. Intranasal steroids versus placebo or no intervention for chronic rhinosinusitis. Cochrane Database Syst Rev 2016;4:CD011996.  Back to cited text no. 9
    
10.
Kalish L, Snidvongs K, Sivasubramaniam R, Cope D, Harvey RJ. Topical steroids for nasal polyps. Cochrane Database Syst Rev 2012;12:CD006549.  Back to cited text no. 10
    
11.
Snidvongs K, Thanaviratananich S. Update on Intranasal Medications in Rhinosinusitis. Curr Allergy Asthma Rep 2017;17:47.  Back to cited text no. 11
    
12.
Kulkarni VS, Shaw C. Essential Chemistry for Formulators of Semisolid and Liquid Dosages. eBook, Academic Press; 2015.  Back to cited text no. 12
    
13.
Moller W, Saba GK, Haussinger K, Becker S, Keller M, Schuschnig U. Nasally inhaled pulsating aerosols: Lung, sinus and nose deposition. Rhinology 2011;49:286-91.  Back to cited text no. 13
    
14.
Leach CL, Kuehl PJ, Chand R, McDonald JD. Nasal deposition of HFA-beclomethasone, aqueous fluticasone propionate and aqueous mometasone furoate in allergic rhinitis patients. J Aerosol Med Pulm Drug Deliv 2015;28:334-40.  Back to cited text no. 14
    
15.
Ly J, Morales A, Salas K, Cabrera J, Dalvi M, Zeng ZM. Qnasl® non-aqueous nasal aerosol delivers softer sprays than aqueous Flonase®, Nasacort AQ®, and Nasonex®. J Allergy Clin Immunol 2013;131:AB39.  Back to cited text no. 15
    
16.
Feng AL, Wesely NC, Hoehle LP, Phillips KM, Yamasaki A, Campbell AP, et al. A validated model for the 22-item Sino-Nasal Outcome Test subdomain structure in chronic rhinosinusitis. Int Forum Allergy Rhinol 2017;7:1140-8.  Back to cited text no. 16
    
17.
Naghdi S, Anjeie F, Nakhostin Ansari N, Fathali MJ. Development, cultural adaptation, reliability and validity of Persian version of Sino-Nasal outcome test in chronic rhinosinusitis: A brief report. Tehran Univ Med J. 2013; 70 (11):735-740.  Back to cited text no. 17
    
18.
Lund VJ, Kennedy DW. Staging for rhinosinusitis. Otolaryngol Head Neck Surg 1997;117:S35-40.  Back to cited text no. 18
    
19.
Luskin AT, Blaiss MS, Farrar JR, Settipane R, Hayden ML, Stoloff S, et al. Is there a role for aerosol nasal sprays in the treatment of allergic rhinitis: A white paper. Allergy Asthma Proc 2011;32:168-77.  Back to cited text no. 19
    
20.
Small P, Houle PA, Day JH, Briscoe M, Gold M, Brodarec I, et al. A comparison of triamcinolone acetonide nasal aerosol spray and fluticasone propionate aqueous solution spray in the treatment of spring allergic rhinitis. J Allergy Clin Immunol 1997;100:592-5.  Back to cited text no. 20
    
21.
Kaliner MA. Patient preferences and satisfaction with prescribed nasal steroids for allergic rhinitis. Allergy Asthma Proc 2001;22:S11-5.  Back to cited text no. 21
    
22.
Storms WW. Introduction: Patient preference of inhaled nasal corticosteroids. Allergy Asthma Proc 2001;22:S1-3.  Back to cited text no. 22
    
23.
Neffen H, Mello JF Jr., Sole D, Naspitz CK, Dodero AE, Garza HL, et al. Nasal allergies in the Latin American population: Results from the Allergies in Latin America survey. Allergy Asthma Proc 2010;31 Suppl 1:S9-27.  Back to cited text no. 23
    
24.
Dunn AM, Wilson RS, Baggott PJ. A comparison of beclomethasone dipropionate aqueous nasal spray and beclomethasone dipropionate pressurized nasal spray in the management of seasonal rhinitis. Postgrad Med J 1984;60:404-6.  Back to cited text no. 24