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.

Seasonal Allergic Rhinitis is Effectively Assuaged With an Essential Oil Inhaler (AromaStick®): Results From a Randomized, Controlled, Double-blind Effectiveness Trial

2019 ◽  
Vol 9 (1) ◽  
pp. 39-46
Author(s):  
Rainer Schneider
Keyword(s):  
Allergic Rhinitis ◽  
Essential Oil ◽  
Seasonal Allergic Rhinitis ◽  
Symptom Relief ◽  
Specific Treatment ◽  
Blood Oxygenation ◽  
Effectiveness Trial ◽  
Double Blind ◽  
Beneficial Effects ◽  
Randomized Controlled

Background: There are effective pharmaceutical agents to treat seasonal allergic rhinitis, but more and more individuals resort to alternative forms of treatment. One possible alternative candidate is essential oils. Recently, an inhaler specifically designed to deliver essential oil scents has proven very effective in treating various medical parameters (e.g., blood pressure, heart rate, cortisol, blood oxygenation, or pain). </P><P> Objective: This work investigates whether an inhaler (AromaStick&#174; ‘Nasal Fresh’) designed to clear the nasal passageway and reduce congestion has beneficial effects in individuals suffering from seasonal allergic rhinitis. Methods: A two-armed, randomized, controlled, double-blind effectiveness trial involving individuals with medium to strong symptoms was conducted to investigate the inhaler’s specific treatment effects. Results: Over a period of two weeks, the odor inhaler strongly reduced allergic symptoms for both overall AR symptomatology (d = 1.2) and individual symptomatic allergic rhinitis burden (d = 1.7). Conclusion: The inhaler produced strong symptom relief. Effects were largest in individuals suffering primarily from nasal symptoms.

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.

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.

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