The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Participants
2.3. Intervention
2.4. Outcome Measures
2.5. Sample Size
2.6. Statistical Analysis
3. Results
3.1. Participants
3.2. Efficacy Outcomes
3.3. Safety Outcomes
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristics | Total | Elonide | Nasonex | Placebo | p Value |
---|---|---|---|---|---|
Subjects randomized to treatment, No. (%) | 163 (100) | 56 (34) | 54 (33) | 53 (33) | - |
Age, mean (SD), (y) | 31.23 (8.29) | 32.16 (8.61) | 31.57 (8.41) | 29.91 (7.78) | 0.25 |
Gender, No. (%) | |||||
Male | 51 (31.29) | 19 (33.93) | 16 (29.63) | 16 (30.19) | 0.87 |
Female | 112 (68.71) | 37 (66.07) | 38 (70.37) | 37 (69.81) | |
Intent to treat (ITT) | 163 | 56 | 54 | 53 | - |
Subjects completed treatment | 155 | 53 | 52 | 50 | - |
Subjects discontinued treatment, No. (%) | 8 (4.9) | 3 (1.84) | 2 (1.23) | 3 (1.84) | - |
Reason for discontinuation: | |||||
Lost to follow-up | 6 | 2 | 2 | 2 | - |
Did not wish to continue | 2 | 1 | 0 | 1 | - |
Medication(s): | |||||
Nasal spray only, No. (%) | 157 (96.32) | 55 (33.74) | 54 (33.13) | 48 (29.45) | - |
Nasal spray + antihistamine, No. (%) | 6 (3.68) | 1 (0.61) | 0 (0) | 5 (3.07) | - |
VAS (mm), mean (SD) ᵃ | 56.32 (19.74) | 57.09 (17.14) | 54.61 (20.71) | 57.25 (21.38) | 0.71 |
RQOLQ, mean (SD) ᵃ | 2.98 (1.30) | 2.87 (1.17) | 2.91 (1.38) | 3.15 (1.36) | 0.49 |
TNR (Pa/cm3/s), mean (SD) ᵃ | 1.12 (1.62) | 1.37 (2.55) | 1.17 (1.48) | 0.81 (0.83) | 0.26 |
Treatment Group | Outcome Measures | Pretreatment | Post-Treatment | p Value |
---|---|---|---|---|
Elonide | TNR (Pa/cm3/s) | 1.37 (2.55) | 0.56 (0.35) | <0.01 |
VAS (mm) | 57.09 (17.14) | 33.90 (17.80) | <0.01 | |
RQOLQ | 2.87 (1.17) | 1.39 (0.95) | <0.01 | |
Nasonex® | TNR (Pa/cm3/s) | 1.17 (1.48) | 0.77 (0.60) | <0.01 |
VAS (mm) | 54.61 (20.71) | 37.04 (21.73) | <0.01 | |
RQOLQ | 2.91 (1.38) | 1.59 (1.22) | <0.01 | |
Placebo | TNR (Pa/cm3/s) | 0.81 (0.83) | 0.64 (0.40) | <0.01 |
VAS (mm) | 57.25 (21.38) | 40.51 (21.48) | <0.01 | |
RQOLQ | 3.15 (1.36) | 1.88 (1.39) | <0.01 |
Treatment Group | ||||
---|---|---|---|---|
Side Effects | Elonide (n = 56) | Nasonex® (n = 54) | Placebo (n = 53) | Total |
Headaches | 2 (4%) | 4 (7%) | 3 (6%) | 9 (17%) |
Sore throat | 2 (4%) | 4 (7%) | 3 (6%) | 9 (17%) |
Cough | 1 (2%) | 2 (4%) | 1 (2%) | 4 (8%) |
Nasal dryness | 1 (2%) | 1 (2%) | 0 (0%) | 2 (4%) |
Nasal irritation | 0 (0%) | 1 (2%) | 1 (2%) | 2 (4%) |
Epistaxis | 0 (0%) | 1 (2%) | 0 (0%) | 1 (2%) |
Imbalance | 0 (0%) | 1 (2%) | 0 (0%) | 1 (2%) |
Total | 6 (12%) | 14 (26%) | 8 (16%) | 28 (54%) |
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Gendeh, H.S.; Hamizan, A.W.; Husain, S.; Nawi, A.M.; Zahedi, F.D.; Megat Ismail, N.F.; M. Farit, N.A. The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial. J. Clin. Med. 2024, 13, 1883. https://doi.org/10.3390/jcm13071883
Gendeh HS, Hamizan AW, Husain S, Nawi AM, Zahedi FD, Megat Ismail NF, M. Farit NA. The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial. Journal of Clinical Medicine. 2024; 13(7):1883. https://doi.org/10.3390/jcm13071883
Chicago/Turabian StyleGendeh, Hardip S., Aneeza W. Hamizan, Salina Husain, Azmawati M. Nawi, Farah D. Zahedi, Nur Fadhilah Megat Ismail, and N. Ammal M. Farit. 2024. "The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial" Journal of Clinical Medicine 13, no. 7: 1883. https://doi.org/10.3390/jcm13071883
APA StyleGendeh, H. S., Hamizan, A. W., Husain, S., Nawi, A. M., Zahedi, F. D., Megat Ismail, N. F., & M. Farit, N. A. (2024). The Efficacy of Elonide Nasal Corticosteroids in Managing Allergic Rhinitis: A Randomized, Double-Blinded Trial. Journal of Clinical Medicine, 13(7), 1883. https://doi.org/10.3390/jcm13071883