55 A placebo-controlled, double-blind, randomized, parallel study comparing the safety and efficacy of Seldane-D and Tavist-D in the treatment of patients with seasonal allergic rhinitis

1991 ◽  
Vol 87 (1) ◽  
pp. 152
Author(s):  
A SEGAL ◽  
P BOGGS ◽  
C FALLIERS ◽  
W PODLESKI ◽  
J GRANT ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Parallel Study ◽  
Double Blind ◽  
Safety And Efficacy

A Comparison of Loratadine, a New Nonsedating Antihistamine, with Clemastine and Placebo in Patients with Fall Seasonal Allergic Rhinitis

1987 ◽  
Vol 1 (3) ◽  
pp. 151-154 ◽  
Author(s):  
James P. Kemp ◽  
Sami L. Bahna ◽  
Paul Chervinsky ◽  
Gary S. Rachelefsky ◽  
James M. Seltzer ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Parallel Study ◽  
Double Blind ◽  
Daily Diaries ◽  
Ocular Symptoms ◽  
Symptom Scores ◽  
The Mean ◽  
Long Acting ◽  
To Receive

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.

scholarly journals Evaluation of efficacy and safety of montelukast and levocetirizine FDC tablet compared to montelukast and levocetirizine tablet in patients with seasonal allergic rhinitis: a randomized, double blind, multicentre, phase III trial

2020 ◽  
Vol 7 (1) ◽  
pp. 83
Author(s):  
Sagar Panchal ◽  
Saiprasad Patil ◽  
Hanmant Barkate
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Phase Iii ◽  
Fixed Dose ◽  
Controlled Study ◽  
Global Evaluation ◽  
Double Blind ◽  
Nasal Symptoms

<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>

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.

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