Double-Blind, Placebo-Controlled Trial of Reformulated Azelastine Nasal Spray in Patients with Seasonal Allergic Rhinitis

2009 ◽  
Vol 23 (5) ◽  
pp. 512-517 ◽  
Author(s):  
Jonathan A. Bernstein ◽  
Bruce Prenner ◽  
Berrylin J. Ferguson ◽  
Jay Portnoy ◽  
William J. Wheeler ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Dose Response ◽  
Seasonal Allergic Rhinitis ◽  
Nasal Congestion ◽  
Controlled Trial ◽  
Taste Masking ◽  
Comparable Efficacy ◽  
Original Formulation ◽  
Double Blind

Background Azelastine nasal spray is a topical antihistamine with a distinctive taste that may be objectionable to some patients. The primary objectives of this clinical trial were (1) to determine if a reformulated azelastine nasal spray (Astepro) with sucralose as a taste-masking agent provides comparable efficacy to the original formulation (Astelin) and (2) to evaluate dose–response relationships between groups. Methods Eight hundred thirty-five patients with seasonal allergic rhinitis were randomized to six treatment groups: (1) original azelastine nasal spray, 1 spray/nostril b.i.d.; (2) reformulated azelastine, 1 spray/nostril b.i.d.; (3) placebo, 1 spray/nostril b.i.d.; (4) original azelastine nasal spray, 2 sprays/nostril b.i.d., (5) reformulated, 2 sprays/nostril b.i.d.; and (6) placebo, 2 sprays/nostril b.i.d. The primary efficacy variable was the change from baseline to day 14 in total nasal symptom score (TNSS) consisting of runny nose, sneezing, itchy nose, and nasal congestion. Results Original azelastine nasal spray and the reformulated spray produced comparable improvements in the TNSS at both dosages. There was a dose-related difference in TNSS comparing the 1- and 2-spray dosages. The percentage changes from baseline in the TNSS in the 2-sprays/nostril dosage groups were 27.9% (p < 0.001) with the reformulated nasal spray, 23.5% (p < 0.01) with the original formulation, and 15.4% with placebo. The incidence of bitter taste was 7% with the reformulated spray and 8% with the original at the 2-sprays/nostril dosage. Conclusion The results of this study showed efficacy both with original azelastine nasal spray and with the reformulated nasal spray and a clear dose–response difference between the 1- and 2-spray dosages.

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial Comparing the Efficacy and Tolerability of Levocabastine-Oxymetazoline Nasal Spray with Levocabastine and Oxymetazoline Alone in the Symptomatic Treatment of Seasonal Allergic Rhinitis

1996 ◽  
Vol 10 (2) ◽  
pp. 105-112 ◽  
Author(s):  
William Busse ◽  
Monique Janssens ◽  
Gerald Eisen ◽  
Eastern Us ◽  
Canada William Busse ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Treatment Period ◽  
Nasal Spray ◽  
Therapeutic Efficacy ◽  
Seasonal Allergic Rhinitis ◽  
Nasal Congestion ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Double Blind ◽  
Entire Treatment Period

A total of 1015 patients participated in three 1-week, multicenter, double-blind, randomized, placebo-controlled trials undertaken to assess the therapeutic efficacy and tolerability of twice daily administration of a nasal spray containing a combination of levocabastine (0.5 mg/mL) and oxymetazoline (0.5 mg/mL) (levocabastine-D) versus that of either agent alone in the treatment of ragweed-induced seasonal allergic rhinitis. As these studies shared a common protocol, the data have been pooled. Patient assessments revealed that the mean change in area under the curve (AUC) from baseline over the entire treatment period was significantly greater in patients treated with levocabastine or levocabastine-D than in those receiving placebo for all symptoms evaluated (nasal congestion; P < 0.05 and sneezing, rhinorrhea, nasal itching, ocular symptoms, total key symptoms, total all symptoms; P < 0.001). Corresponding changes in patients treated with oxymetazoline alone did not attain statistical significance. Day-by-day analysis demonstrated that the beneficial effects seen with levocabastine and levocabastine-D were maintained throughout the treatment period for all symptoms except nasal congestion (Days 1 and 2 only); oxymetazoline provided significant relief from nasal congestion only and only on the first day of treatment. Investigator assessments revealed similar trends. Global evaluations of therapeutic efficacy revealed that 44% of levocabastine-treated patients and 52% of patients treated with levocabastine-D considered therapeutic efficacy to be excellent or good compared with 39% of those on oxymetazoline and 26% on placebo (P < 0.01 versus placebo). Adverse experiences were reported by 30% of levocabastine-treated patients, 40% of patients treated with levocabastine-D and oxymetazoline, and 32% of placebo controls, with no statistically significant intergroup differences in incidence or type. In conclusion, twice daily levocabastine nasal spray is effective and well-tolerated for the treatment of ragweed-induced seasonal allergic rhinitis with an adverse effect profile comparable with that of placebo. Addition of oxymetazoline to the topical antihistamine does not appear to provide significant additional clinical benefit compared to that observed with levocabastine alone, and tachyphylaxis to the decongestant effect of the topical vasoconstrictor occurs within days of treatment initiation.

Effect of mometasone furoate nasal spray on moderate-to-severe nasal congestion in seasonal allergic rhinitis: A responder analysis

2019 ◽  
Vol 40 (3) ◽  
pp. 173-179 ◽  
Author(s):  
Eduardo Urdaneta ◽  
Kaan Tunceli ◽  
Davis Gates
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Seasonal Allergic Rhinitis ◽  
Nasal Congestion ◽  
Mometasone Furoate ◽  
Double Blind ◽  
Positive Skin ◽  
Once Daily ◽  
Responder Analysis ◽  
End Point

Background: Nasal congestion is consistently identified as the most bothersome symptom of seasonal allergic rhinitis (SAR), and, in guidelines, intranasal corticosteroids are the preferred treatment for nasal congestion. Objective: The aim of this post hoc cumulative responder analysis was to examine the nasal congestion response in detail by depicting the level of response obtained in two double-blind, placebo controlled studies of mometasone furoate nasal spray (MFNS) therapy for SAR, conducted from August to October 2008 at U.S. sites, in which nasal congestion was prespecified as the primary end point. Methods: Patients ≥12 years of age with a ≥2-year SAR history, positive skin test result, and moderate or severe nasal congestion were randomly assigned to once-daily treatment in the morning with MFNS or placebo for 15 days. The primary end point was the change from baseline in morning and evening reflective nasal congestion scores averaged over days 1‐15. Treatment response, which ranged from >0% to >90% improvement, was evaluated at 10% intervals; >30% and >50% improvements were further evaluated by using the Mietinnen-Nurminen method weighted by study to test the differences of proportions. The Breslow-Day equal odds ratios test was used to justify pooling. Results: Of the 344 and 340 patients in the MFNS and placebo groups, respectively, the proportions of patients who experienced a >30% response in nasal congestion, averaged over 15 days, were 37% versus 19% in the MFNS and placebo groups, respectively (p < 0.001). Those who experienced a >50% response were 13% and 7%, respectively (p = 0.003). Among the patients treated with MFNS, the mean response was greater during the second versus the first week of treatment. There was no difference between responses in the morning versus evening or for patients with moderate versus severe nasal congestion at baseline. Conclusion: MFNS is effective in relieving moderate-to-severe nasal congestion in patients with SAR. The response to MFNS is maintained with once-daily administration and improves with continuous use over 2 weeks.

Late Phase Inflammation during Nasal Grass and Ragweed Challenge in a Double-Blind Placebo Controlled Trial with Astemizole

1995 ◽  
Vol 9 (3) ◽  
pp. 169-174 ◽  
Author(s):  
Marianne Frieri ◽  
James Madden ◽  
Myron Zitt ◽  
Nanjundaiah S. Kumar ◽  
Maria Knapik
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Congestion ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Interleukin 1 ◽  
Late Phase ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Nasal Provocation ◽  
Anti Inflammatory

Allergic rhinitis is an IgE-mediated inflammatory reaction characterized by an early “classic” immediate hypersensitivity response and/or a subsequent late phase response. Nasal provocation to antigen challenge is a useful method of evaluating this dual response. Several H1 antagonists may exhibit antiinflammatory properties by diminishing histamine release or inhibiting eosinophil chemotaxis. To determine whether astemizole has any anti-inflammatory characteristics, we studied 20 patients with allergic rhinitis in a double-blind placebo-controlled fashion after a 4-week course of treatment with this H1 antagonist. Nasal provocation over 30 minutes was performed out of season using increasing concentrations of grass or ragweed extract from 10–1000 PNU. Patients were evaluated for their clinical response, and nasal lavage secretions were analyzed over 6 hours by ELISA for alpha interleukin-1, interleukin-8, albumin, and histamine levels. Total sneezing and other symptom scores for rhinorrhea, nasal congestion, and pruritus were decreased in astemizole-treated compared to placebo-treated patients both at 30 minutes (early phase), and at 3 and 6 hours (late phase) after nasal provocation. However, these results did not reach statistical significance. Nasal α IL-1 levels diminished from diluent control lavage to a significantly greater degree in astemizole than in placebo-treated patients (P < 0.05). This diminution in late phase α IL-1 suggests that astemizole may possess anti-inflammatory properties.

scholarly journals From clinical guidelines to practice. Clinical experience in treatment of patients with allergic rhinitis

2021 ◽  
pp. 62-67
Author(s):  
A. Y. Ovchinnikov ◽  
N. A. Miroshnichenko ◽  
E. M. Khon ◽  
N. P. Jimsheleishvili ◽  
V. A. Simsovа ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Inflammatory Diseases ◽  
Nasal Congestion ◽  
Controlled Study ◽  
Double Blind ◽  
Entire Treatment Period ◽  
Treatment Groups ◽  
Histamine H1 Receptors ◽  
To Receive

Introduction. Antihistamines are the most commonly prescribed class of medications for the treatment of allergic rhinitis (AR). However, they are also widely used in the treatment of inflammatory diseases of the ENT organs. One such drug is levocytirizine, (R) an enantiomer of cetirizine, which is a selective antagonist of peripheral histamine H1-receptors. This article analyzes the properties of levocytirizine in terms of safety and efficacy in allergic rhinitis.Aim of the study is to assess the efficacy of levocetirizine in patients with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) versus placebo, and safety for patients with allergic rhinitis.Materials and methods. In this, double-blind, placebo-controlled study, 52 patients with year-round allergic rhinitis and 28 patients with seasonal allergic rhinitis were randomized to receive levocetirizine 5 mg/day once or placebo. Mean overall measures of five symptoms (nasal congestion, nasal itching, itchy eyes, rhinorrhea, and sneezing) were compared between treatment groups at 1, 2, and 4 weeks. All individual symptom scores were also examined.Results. Levocetirizine showed a significant improvement in the condition of patients with CAR and SAR over the entire treatment period compared to placebo. Assessment of individual symptoms showed statistically significant differences in favor of levocetirizine. Conclusion. Levocetirizine is an effective, safe, and well-tolerated drug for the treatment of allergic rhinitis.

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