The Efficacy and Safety of Nedocromil Sodium 1% Nasal Solution in the Treatment of Ragweed Seasonal Allergic Rhinitis

1991 ◽  
Vol 5 (6) ◽  
pp. 241-248 ◽  
Author(s):  
Howard J. Schwartz ◽  
Lorraine D. Ellis ◽  
Theodore H. Sher
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Sleep Disturbances ◽  
Drug Efficacy ◽  
Baseline Period ◽  
Nedocromil Sodium ◽  
Double Blind ◽  
Runny Nose ◽  
Nasal Irritation ◽  
Adverse Experiences

The safety and efficacy of nedocromil sodium 1% nasal solution in the treatment of patients with ragweed seasonal allergic rhinitis was assessed in a double-blind group-comparative study. After a 1-week baseline period that coincided with the start of the ragweed season, patients were randomized to receive either nedocromil sodium 1% nasal solution or matched placebo (1 spray per nostril q.i.d.) for 8 weeks. The primary efficacy variable was the mean daily diary card symptom score for the 3-week peak pollen period. During this time, patients treated with nedocromil sodium showed a significant decrease in sneezing, runny nose symptoms, and sleep disturbances compared with the placebo group. Furthermore, the patient's and physician's assessments of the drug efficacy showed significant differences favoring the nedocromil sodium treatment. No serious adverse experiences were reported during the study. Both groups reported transient minor adverse experiences including sneezing and nasal irritation. Nedocromil sodium was effective in relieving symptoms associated with seasonal allergic rhinitis during peak ragweed seasonal challenge without significant adverse effects.

scholarly journals Comparison of Budesonide Turbuhaler with Budesonide Aqua in the Treatment of Seasonal Allergic Rhinitis

1998 ◽  
Vol 5 (6) ◽  
pp. 455-460 ◽  
Author(s):  
William H Yang ◽  
Jerry Dolovich ◽  
Michel A Drouin ◽  
Paul Keith ◽  
Jennifer Haddon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Nasal Symptom ◽  
Double Blind ◽  
Nasal Irritation ◽  
Eye Symptoms ◽  
Assess Quality ◽  
Substantial Control

OBJECTIVE: To compare the effect of budesonide Turbuhaler 400 µg/day with budesonide aqua 256 µg/day in the treatment of seasonal allergic rhinitis (SAR). Secondarily to ascertain patients' preferences for the two nasal devices and to assess quality of life.DESIGN: Randomized, multicentre, double-blind, double- dummy, parallel groups study.SETTING: Private practices and hospital clinics in Ontario, Quebec and Manitoba.POPULATION: Two hundred and eighty-four out-patients with SAR, who were symptomatic during the ragweed season, volunteered for enrolment (243 randomized).RESULTS: Mean daily nasal symptom scores were significantly reduced with treatment. There were no statistically significant changes from baseline for eye symptoms. Most patients (more than 80%) achieved substantial control of their symptoms with budesonide. The most common nasal and non-nasal adverse events for both groups were epistaxis and headache. Turbuhaler was easier to use and more convenient to carry, had less of an unpleasant taste, and caused less nasal irritation than the aqua spray. More than twice as many patients preferred Turbuhaler to the aqua spray (69% versus 31%). Improvement in quality of life from baseline to clinic visits was statistically significant in both groups.CONCLUSION: Once daily use of 256 mg of budesonide aqua and 400 mg of budesonide Turbuhaler are equally safe and efficacious in the treatment of SAR. Patients preferred the budesonide powder formulation delivered via Turbuhaler two to one over the aqua formulation.

Loratadine and Pseudoephedrine Sulfate: A Double-Blind, Placebo-Controlled Comparison of a Combination Tablet (SCH 434) and Its Individual Components in Seasonal Allergic Rhinitis

1988 ◽  
Vol 2 (2) ◽  
pp. 71-75 ◽  
Author(s):  
Jacques Hébert ◽  
Pierre-Michel Bédard ◽  
Jaime Del Carpio ◽  
Michel Drouin ◽  
Andrzej Gutkowski ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Symptom Relief ◽  
Symptomatic Treatment ◽  
Double Blind ◽  
Combination Tablet ◽  
Nasal Decongestant ◽  
Adverse Experiences ◽  
Parallel Group ◽  
Multi Center Study

SCH 434 is a combination tablet containing the nonsedating antihistamine, loratadine (5 mg), and the well-established nasal decongestant, pseudoephedrine sulfate (120 mg), for twice daily dosing. The efficacy and safety of SCH 434 was compared with its individual components in a 14-day, placebocontrolled, randomized, double-blind, parallel-group, multi-center study in the symptomatic treatment of seasonal allergic rhinitis; 437 patients were evaluated for safety, 417 of whom were also evaluated for efficacy. Throughout the study, SCH 434 provided a significantly greater degree of overall symptom relief than either component alone or placebo. Loratadine alone was also superior to placebo on day 4 and at end point and superior to pseudoephedrine alone on day 4 in decreasing total symptom score. All treatments were well tolerated and no serious or unusual adverse experiences were reported; adverse experiences associated with SCH 434 were typical of the side effects commonly associated with the use of pseudoephedrine. The combination provides for a safe, effective, and convenient alternative for patients requiring the benefits of both an antihistamine and nasal decongestant, but who cannot tolerate, or wish to avoid, the sedative effects of traditional antihistamines.

Brompheniramine Maleate: A Double-Blind, Placebo-Controlled Comparison with Terfenadine for Symptoms of Allergic Rhinitis

1998 ◽  
Vol 12 (4) ◽  
pp. 293-300 ◽  
Author(s):  
William R. Thoden ◽  
Howard M. Druce ◽  
Sandy A. Furey ◽  
Earle A. Lockhart ◽  
Paul Ratner ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Symptom Severity ◽  
Extended Release ◽  
Nasal Symptom ◽  
Double Blind ◽  
Release Formulation ◽  
Extended Release Formulation ◽  
Adverse Experiences ◽  
Severity Scores ◽  
Brompheniramine Maleate

This was a double-blind, randomized, placebo-controlled, multicenter, parallel study comparing the effectiveness, at recommended doses, of an extended-release formulation of brompheniramine maleate and terfenadine in the treatment of allergic rhinitis. Subjects with symptoms of seasonal and/or perennial allergic rhinitis received brompheniramine 12 mg (n = 106), 8 mg (n = 105), terfenadine 60 mg (n = 106), or placebo (n = 53) twice daily for 14 days. On treatment days 3, 7, and 14, symptom severity ratings (i.e., rhinorrhea, sneezing, nasal congestion, itchy nose, eyes or throat, excessive tearing, postnasal drip) were completed by the physician; subjects and physicians each completed a global efficacy evaluation. Brompheniramine 12 mg and 8 mg and terfenadine were more effective than placebo (p ≤ 0.05) on the physicians’ global; brompheniramine 12 mg was more effective than terfenadine (p ≤ 0.05) on days 7 and 14 and brompheniramine 8 mg on day 3. On the subjects’ global evaluation, brompheniramine 12 mg and 8 mg and terfenadine were more effective than placebo (p ≤ 0.05); brompheniramine 12 mg was more effective than terfenadine (p ≤ 0.05) on days 7 and 14 and brompheniramine 8 mg on day 3. In general, brompheniramine 8 mg was comparable to terfenadine. On days 3 and 7, the total symptom and total nasal symptom severity scores for subjects receiving brompheniramine 12 mg were significantly more improved than for placebo (p < 0.05); terfenadine was not different from placebo; brompheniramine 12 mg was significantly better than terfenadine on day 7 (p < 0.05) for reducing total symptom severity and on days 3, 7, and 14 for reducing total nasal symptom severity. Adverse experiences were reported by 155 (41.9%) of the 370 subjects enrolled in the study. The overall rate of adverse experiences in the brompheniramine 12 mg treatment group (57.5%) was significantly greater (p < 0.05) than for brompheniramine 8 mg (38.1%), terfenadine (31.1%), and placebo (39.6%). In conclusion, an extended-release formulation of brompheniramine 12 mg or 8 mg bid alleviates allergic rhinitis symptoms and brompheniramine 12 mg provides significantly better relief of these symptoms than terfenadine 60 mg bid.

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>

A Parallel-Group Comparison of Astemizole and Loratadine for the Treatment of Perennial Allergic Rhinitis

1997 ◽  
Vol 25 (4) ◽  
pp. 175-181 ◽  
Author(s):  
H Al-Muhaimeed
Keyword(s):  
Allergic Rhinitis ◽  
Statistical Significance ◽  
Double Blind Study ◽  
Perennial Allergic Rhinitis ◽  
Double Blind ◽  
Once Daily ◽  
Runny Nose ◽  
Parallel Group ◽  
The Mean ◽  
To Receive

The efficacy and safety of the two antihistamines, astemizole and loratadine, were compared in a double-blind study of 84 patients with perennial allergic rhinitis. Patients were randomized to receive orally either astemizole 10 mg once daily ( n = 40) or loratadine 10 mg once daily ( n = 44) for 1 week. No other antirhinitis medication was allowed during the study. By day 7 the mean daily symptom scores, recorded on diary cards, were lower in patients receiving astemizole than in those receiving loratadine for runny nose, itchy nose and sneezing, although not for blocked nose, and treatment differences only reached statistical significance for runny nose. After 7 days, 53.75% of patients on astemizole and 38.6% on loratadine were free of symptoms, and 87% of patients on astemizole described the treatment as good or excellent compared with 62% on loratadine. The present results suggest that astemizole may be more effective than loratadine in controlling symptoms of perennial allergic rhinitis.

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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