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 ◽  
...  

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.

2000 ◽  
Vol 79 (4) ◽  
pp. 254-267 ◽  
Author(s):  
Edith A. McFadden ◽  
Anil Gungor ◽  
Bernard Ng ◽  
Bülent Mamikoglu ◽  
Rizwan Moinuddin ◽  
...  

In this double-blind, placebo-controlled, crossover, parallel study, we treated 20 adults who had seasonal allergic rhinitis with once-daily fixed-combination loratadine/pseudoephedrine sulfate to observe its effect on relieving symptoms, primarily nasal congestion. Acoustic rhinometry detected a trend toward improvement in nasal patency, although the difference between pre- and post-treatment measures was not statistically significant. Endoscopic inferior turbinate photography documented that treatment led to statistically significant reductions in the amount of nasal edema and nasal secretions. The results of a quality-of-life questionnaire suggested that treatment alleviated nasal and ocular symptoms of rhinoconjunctivitis. An analysis of subjective visual analog scale scores showed a trend toward improvement in most but not all nasal symptoms. We conclude that once-a-day fixed-combination loratadine/pseudoephedrine is effective in relieving nasal congestion in patients with seasonal allergic rhinitis.


1996 ◽  
Vol 10 (2) ◽  
pp. 105-112 ◽  
Author(s):  
William Busse ◽  
Monique Janssens ◽  
Gerald Eisen ◽  
Eastern Us ◽  
Canada William Busse ◽  
...  

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.


Author(s):  
Sagar Panchal ◽  
Saiprasad Patil ◽  
Hanmant Barkate

<p class="abstract"><strong>Background:</strong> 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.</p><p class="abstract"><strong>Methods:</strong> 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.  </p><p class="abstract"><strong>Results:</strong> 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.</p><p class="abstract"><strong>Conclusions:</strong> 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.</p>


2009 ◽  
Vol 23 (5) ◽  
pp. 512-517 ◽  
Author(s):  
Jonathan A. Bernstein ◽  
Bruce Prenner ◽  
Berrylin J. Ferguson ◽  
Jay Portnoy ◽  
William J. Wheeler ◽  
...  

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.


1987 ◽  
Vol 1 (3) ◽  
pp. 151-154 ◽  
Author(s):  
James P. Kemp ◽  
Sami L. Bahna ◽  
Paul Chervinsky ◽  
Gary S. Rachelefsky ◽  
James M. Seltzer ◽  
...  

Loratadine is a new nonsedating long-acting H1-antagonist which has been shown to be effective at various doses in controlling symptoms of spring seasonal allergic rhinitis. In this multicenter, double-blind, parallel study, 313 adolescent and adult patients with moderate to severe, skin-test positive, fall seasonal rhinitis were randomized to receive either loratadine, 10 mg, in the morning and placebo in the evening, clemastine 1 mg. b.i.d., or placebo b.i.d. for 2 weeks. Patients maintained daily diaries of nasal and ocular symptoms and of adverse effects. They were evaluated before and 7 and 14 days after starting treatment. The mean symptom scores on days 7 and 14 showed greater improvement with both loratadine and clemastine treatments than with placebo. The incidence of somnolence in the loratadine group by comparison with the placebo group was not statistically different, whereas clemastine caused significantly more drowsiness than did placebo. We conclude that loratadine, 10 mg, once a day is as effective as clemastine b.i.d. in decreasing the symptoms of fall seasonal rhinitis and the incidence of somnolence with loratadine is not statistically different from that with placebo.


2019 ◽  
Vol 40 (3) ◽  
pp. 173-179 ◽  
Author(s):  
Eduardo Urdaneta ◽  
Kaan Tunceli ◽  
Davis Gates

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.


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