A Post-Hoc Analysis of Improvement in Individual Nasal Symptoms by Their Baseline Severity Following Treatment with Ciclesonide Hydrofluoroalkane Nasal Aerosol in Patients with Seasonal Allergic Rhinitis

Background: To evaluate efficacy, safety and tolerability of Montelukast 10 mg+levocetirizine 5 mg FDC compared to either montelukast 10 mg or levocetirizine 5 mg given alone in seasonal allergic rhinitis (SAR) patients.Methods: Phase III, multicentre, randomized, double blind, parallel group, active controlled study was conducted in 279 SAR patients at 16 sites across India. Efficacy was assessed using daytime nasal symptoms score (Primary efficacy outcome), night-time symptoms score, daytime eye symptom score, patient's global evaluation, physician's global evaluation, rhino-conjunctivitis quality-of-life score. Results: At end of treatment there was statistically significant evidence from the per protocol analysis that patients on FDC had a greater improvement in change from baseline in daytime nasal symptoms score than patients who received Montelukast (p=0.0266) or Levocetirizine (p=0.0409). These results were consistent with the Intent to treat analysis. Analysis of the secondary efficacy endpoints provided numerically greater improvement in the nighttime symptoms score, daytime eye symptoms score, and rhinoconjunctivitis quality-of-life scores in the FDC group as compared to the Montelukast group or Levocetirizine group. The FDC of Montelukast and Levocetirizine was found to be safe and generally well tolerated. The majority of adverse events were mild in severity, resolved without treatment and were unrelated to study medication.Conclusions: Fixed dose combination of Montelukast and Levocetirizine was safe, generally well tolerated and superior on efficacy compared to Montelukast or Levocetirizine in patients of seasonal allergic rhinitis.

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Once-daily Fluticasone Furoate∗ Nasal Spray (FF) Provides 24-hour Relief of the Nasal Symptoms of Seasonal Allergic Rhinitis (SAR) in Children ages 2-11 Years ∗USAN approved name

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2006.12.566 ◽

2007 ◽

Vol 119 (1) ◽

pp. S305 ◽

Cited By ~ 1

Author(s):

E.O. Meltzer ◽

I. Tripathy ◽

J. Lee ◽

J. Lim ◽

A. Ellsworth ◽

...

Keyword(s):

Allergic Rhinitis ◽

Nasal Spray ◽

Seasonal Allergic Rhinitis ◽

Fluticasone Furoate ◽

Once Daily ◽

Nasal Symptoms

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Fluticasone propionate aqueous nasal spray improves nasal symptoms of seasonal allergic rhinitis when used as needed (prn)

Annals of Allergy Asthma & Immunology ◽

10.1016/s1081-1206(10)62057-1 ◽

2003 ◽

Vol 91 (1) ◽

pp. 44-48 ◽

Cited By ~ 23

Author(s):

Mark S. Dykewicz ◽

Harold B. Kaiser ◽

Robert A. Nathan ◽

Stacey Goode-Sellers ◽

Cindy K. Cook ◽

...

Keyword(s):

Allergic Rhinitis ◽

Fluticasone Propionate ◽

Nasal Spray ◽

Seasonal Allergic Rhinitis ◽

Nasal Symptoms

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Topical steroids are better than leukotriene receptor antagonists at relieving nasal symptoms of seasonal allergic rhinitis

BMJ ◽

10.1136/bmj.333.7561.0-e ◽

2006 ◽

Vol 333 (7561) ◽

Keyword(s):

Allergic Rhinitis ◽

Seasonal Allergic Rhinitis ◽

Topical Steroids ◽

Receptor Antagonists ◽

Leukotriene Receptor Antagonists ◽

Nasal Symptoms ◽

Leukotriene Receptor ◽

Better Than

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Intranasal fluticasone propionate provided greater relief compared to oral montelukast for nasal congestion and other daytime and evening nasal symptoms of seasonal allergic rhinitis

Journal of Allergy and Clinical Immunology ◽

10.1016/s0091-6749(03)80221-x ◽

2003 ◽

Vol 111 (2) ◽

pp. S85

Author(s):

B.G. Martin ◽

C.P. Andrews ◽

J.H. van Bavel ◽

F.C. Hampel ◽

E.E. Philpot ◽

...

Keyword(s):

Allergic Rhinitis ◽

Fluticasone Propionate ◽

Seasonal Allergic Rhinitis ◽

Nasal Congestion ◽

Nasal Symptoms

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Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Efficacy Analysis of a Phase III Study Performed in Russia

International Archives of Allergy and Immunology ◽

10.1159/000518754 ◽

2021 ◽

pp. 1-8

Author(s):

Alexander V. Karaulov ◽

Natalia I. Ilina ◽

Natalia Shartanova ◽

Aleksandr Maslakov ◽

Luiz Lucio

Keyword(s):

Allergic Rhinitis ◽

Triamcinolone Acetonide ◽

Mixed Model ◽

Linear Mixed Model ◽

Nasal Symptom ◽

Phase Iii ◽

Double Blind ◽

Post Hoc Analysis ◽

Post Hoc ◽

To Receive

Introduction: Allergic rhinitis (AR) is a disease which affects >24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks. Methods: NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population. Results: Of 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were −7.78 (95% CI: −8.1701 to −7.3967; p < 0.001) and −7.52 (−7.9053 to −7.1320; p < 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses. Conclusions: TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.

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