acrivastine and Rhinitis--Allergic--Seasonal

Acrivastine is a short acting histamine H1-receptor antagonist with a rapid onset of action. Double-blind clinical trials have shown acrivastine (usually 8mg three times daily) to be an effective and well tolerated antihistamine in the treatment of chronic urticaria and allergic rhinitis. Acrivastine was more effective than placebo and similar in efficacy to clemastine or terfenadine in the treatment of seasonal allergic rhinitis. In the treatment of dermatoses in which histamine has a pathogenetic role, the efficacy of acrivastine was superior to that of placebo and similar to that of usual dosages of clemastine, hydroxyzine, chlorpheniramine, cyproheptadine or terfenadine. Acrivastine caused less drowsiness than clemastine, the incidence of adverse effects being indistinguishable from that with placebo or terfenadine. Thus, acrivastine is an effective addition to drugs currently available for the treatment of patients with allergic diseases in whom a histamine H1-receptor antagonist is indicated. Because of its rapid onset of action acrivastine will be particularly useful for 'on demand' therapy in patients with intermittent symptoms.

Topics: Dermatitis, Atopic; Histamine H1 Antagonists; Humans; Rhinitis, Allergic, Seasonal; Triprolidine; Urticaria

Topics: Cetirizine; Cyproheptadine; Histamine H1 Antagonists; Humans; Hydroxyzine; Loratadine; Rhinitis, Allergic, Seasonal; Triprolidine; Urticaria

Acrivastine is an antihistamine with reduced sedating potential. This comprehensive review of clinical experience with acrivastine in allergic rhinitis considers all currently available data both published and, as yet, unpublished. Unequivocal evidence of the efficacy of 8 mg acrivastine three times daily for the control of symptoms of seasonal allergic rhinitis has been provided by 11 placebo-controlled studies involving almost 1000 patients. Additional trials have generated further supportive data as well as evidence for the use of acrivastine in the treatment of perennial allergic rhinitis. In common with most antihistamines, acrivastine alone has limited effect on the symptom of blocked nose. In a further series of 11 studies, mainly conducted in the USA, the combination of 8 mg acrivastine plus 60 mg pseudoephedrine was found to control not only the histamine-mediated symptoms of allergic rhinitis but also blocked nose. There were few adverse events associated with the use of acrivastine and the small increase in incidence of drowsiness over that found with placebo was similar to that observed for terfenadine. The marked absence of other signs of significant depression of the central nervous system (or anticholinergic activity) suggests that acrivastine will be an important addition for the antihistaminic control of symptoms of allergic rhinitis.

Topics: Clinical Trials as Topic; Histamine H1 Antagonists; Humans; Pyridines; Rhinitis, Allergic, Seasonal; Triprolidine

Medications containing a combination antihistamine-decongestant are commonly used for allergic rhinitis yet onset-of-action comparisons for symptom relief after a single dose have not been performed.. To determine the onset of symptom relief and efficacy of antihistamine-decongestant medications (acrivastine-pseudoephedrine and loratadine-pseudoephedrine) compared with placebo in an outdoor park.. This study was conducted during the spring of 1997 using a double-blind, placebo-controlled design. Patients completed baseline rhinitis symptom diaries from 7:30 to 9:30 AM. Subjects with qualifying symptom scores received one dose of either acrivastine-pseudoephedrine, loratadine-pseudoephedrine, or placebo at 10:00 AM. Symptom diaries were recorded for the next 4 hours.. Of 593 patients randomized to treatment, 592 were included in efficacy analysis. Acrivastine-pseudoephedrine and loratadine-pseudoephedrine demonstrated a mean onset-of-action by 45 and 30 minutes respectively for total symptom and rhinitis symptom scores for the five sites. Onset-of-action for nasal congestion scores was 45 minutes for both medications. Sites having higher pollen exposure (>100 pollen grains over 6 hours) demonstrated a difference between the antihistamine combinations: acrivastine-pseudoephedrine had an onset of action at 45 minutes for total symptom and rhinitis symptom scores, and 15 minutes for nasal congestion scores whereas loratadine-pseudoephedrine had onset-of-action for nasal congestion score of 105 minutes but failed to reach significance at any timepoint for total symptom and rhinitis symptom scores.. Both antihistamine-decongestant combinations demonstrate an onset-of-action within 60 minutes of administration but under conditions of higher pollen exposure, the acrivastine combination was more effective for total symptoms, rhinitis symptoms, and nasal congestion with an onset-of-action within 45 minutes for rhinitis symptoms and 15 minutes for congestion.

Topics: Adult; Air Pollutants; Allergens; Anti-Allergic Agents; Double-Blind Method; Drug Combinations; Ephedrine; Female; Histamine H1 Antagonists; Humans; Loratadine; Male; Nasal Decongestants; Pollen; Rhinitis, Allergic, Seasonal; Time Factors; Triprolidine

Semprex-D capsules contain acrivastine 8 mg (a second generation H1-antagonist) plus pseudoephedrine HCl 60 mg and were developed to satisfy the needs of allergy suffers who prefer combination products designed to provide broader symptom relief. Approval of combination products by the US Food and Drug Administration requires demonstration that each component contributes to the overall effectiveness.. The objective of the study was to demonstrate that both acrivastine and pseudoephedrine share in the efficacy of the combination in relieving allergy symptoms in patients sensitive to ragweed pollen.. This was a double-blind, randomized, placebo-controlled, parallel groups, balanced design, multicenter (13 sites) study. Patients 12 years of age or older with skin test reactivity to ragweed were recruited. Patients who qualified for the study were dispensed either (1) acrivastine + pseudoephedrine, (2) acrivastine, (3) pseudoephedrine, or (4) placebo with instructions to take one capsule 4 times daily and to record allergy symptom scores in a symptom diary 3 times daily for 14 days. Assessments of health, global allergy symptoms, protocol compliance, adverse events, and vital signs were also documented.. A total of 702 patients were enrolled in this study. Over the 2-week period, the combination of acrivastine + pseudophedrine was significantly more effective than acrivastine, pseudoephedrine, and placebo for relief of all symptoms (P range .01 to .001); pseudoephedrine for treating symptoms responsive to antihistamines (P = .003); and acrivastine for treating symptoms responsive to nasal decongestants (P < .001). Relatively small increases in adverse experience rates were observed for the combination relative to the placebo.. These findings in a large clinical trial demonstrate that each component of the combination of acrivastine 8 mg plus pseudoephedrine HCl 60 mg contributes to the overall efficacy, thereby supporting the conclusion that the combination is rational, safe, and effective for the treatment of allergic rhinitis.

Topics: Adolescent; Adult; Aged; Allergens; Child; Child, Preschool; Double-Blind Method; Drug Therapy, Combination; Ephedrine; Female; Histamine H1 Antagonists; Humans; Male; Middle Aged; Plant Proteins; Pollen; Rhinitis, Allergic, Seasonal; Triprolidine

Acrivastine is a second-generation H1-antagonist chemically related to triprolidine, but more polar and with less central nervous system penetration than triprolidine.. The efficacy of the antihistamine-decongestant combination product (Semprex-D capsules) containing acrivastine 8 mg plus pseudoephedrine HCl 60 mg was evaluated for the treatment of seasonal allergic rhinitis symptoms.. A total of 676 patients sensitive to mountain cedar pollen was enrolled into a 6-center, randomized, double-blind, placebo-controlled, parallel, 4-group study designed to compare acrivastine + pseudoephedrine, acrivastine, pseudoephedrine, and placebo. Patients with demonstrable diary symptom scores at baseline took study medication (4 doses/day) and recorded symptom scores twice daily for 2 weeks. The effectiveness of the acrivastine + pseudoephedrine combination was examined relative to the individual components and placebo in terms of changes in diary symptom scores.. Over the 2-week period, the combination of acrivastine plus pseudoephedrine was significantly more effective than (1) acrivastine, pseudoephedrine, and placebo (P < .001) for relief of all symptoms; (2) pseudoephedrine (P < .001) for relieving allergy symptoms, ie, running nose, sneezing, itchy nose/throat and tearing; and (3) acrivastine (P < .001) for reducing nasal congestion. Relative to placebo, small increases in adverse experience rates were observed with acrivastine + pseudoephedrine for dry mouth, insomnia, somnolence, and headache.. These findings in a large clinical trial demonstrate (1) the efficacy of acrivastine and (2) that each component of the combination of acrivastine 8 mg plus pseudoephedrine HCl 60 mg contributes to the overall efficacy, thereby supporting the conclusion that the combination is rational, safe, and effective for the treatment of allergic rhinitis.

Topics: Adolescent; Adult; Aged; Double-Blind Method; Drug Therapy, Combination; Ephedrine; Female; Histamine H1 Antagonists; Humans; Male; Middle Aged; Pollen; Rhinitis, Allergic, Seasonal; Trees; Triprolidine

The purpose of this study was to test the hypothesis that learning ability is impaired in patients with seasonal allergic rhinitis relative to untreated individuals and to evaluate a combination compound (acrivastine 8 mg + pseudoephedrine 60 mg) for attenuation of the learning impairment in these patients.. In a previous study employing the same method it was shown that young children (10 to 12 yrs) suffering from seasonal allergic rhinitis performed significantly worse on tests of learning and using knowledge after acute treatment with a sedating antihistamine (diphenhydramine 50 mg) or placebo as compared with nontreated healthy controls. This effect was partially reversed by treatment with loratadine.. Sixty-seven young adults suffering from seasonal allergic rhinitis and 28 matched controls were trained on didactic simulation for three consecutive days. Atopic subjects were treated differentially during training according to a double-blind, randomized, parallel group design with either diphenhydramine hydrochloride 50 mg, a combination compound (acrivastine 8 mg + pseudoephedrine 60 mg, A + P), or placebo, administered qd. After training, all atopic subjects were maintained on A + P treatment for 14 days at which time all groups returned for examination.. Mean performance at the end of training was worse for all atopic subjects combined compared with normal subjects. Subjects treated with diphenhydramine performed significantly worse than either normals (P < .001) or those treated with A + P (P < .001). At the examination, the diphenhydramine group's performance differed significantly from those of the normal (P < .001) and A + P groups (P < .001).. The study supports our previous finding that allergy symptoms reduce learning ability which is further reduced learning ability which is further reduced by diphenhydramine. Atopic subjects with allergies treated with acrivastine + pseudoephedrine learned as well as normal subjects.

Topics: Adolescent; Adult; Diphenhydramine; Double-Blind Method; Drug Combinations; Ephedrine; Female; Histamine H1 Antagonists; Humans; Learning; Learning Disabilities; Male; Memory; Rhinitis, Allergic, Seasonal; Triprolidine

In a placebo-controlled, randomized, and double-blind 1-day field study, the efficacy and onset of action of capsule acrivastine 8 mg were evaluated in 42 patients suffering from allergic rhinoconjunctivitis elicited by natural grass pollen exposure. Before and for 2 h after treatment, the patients scored the severity of five rhinoconjunctivitis symptoms every 10 min on a 0-5 scale (0 = no symptoms; 5 = very severe symptoms). The number of sneezes was recorded, and every 30 min, measurements of nasal peak flow were made. Before treatment, there was no difference in median total symptom score (mTSS) between the acrivastine group (A) and the placebo group (P) (12 and 12, respectively). Time of onset was estimated by an exponential decay model to be 19 min (95% confidence interval 0-39 min). A statistically significant difference in percent reduction of mTSS between A and P was observed for the first time 46 min after treatment start (A = 22%, P = 0%, P < 0.05). A 50% reduction in total symptom score (TSS) was achieved within 60 min by 38% in A and 17% in P (NS), and within 80 min in 52% and 17%, respectively (P < 0.05). The median time for 50% reduction in TSS (MT50) was 80 min for A and > 120 min for P (P < 0.01). The symptom score of sneezing and number of sneezes were evaluated for periods of 30 min. The difference between A and P became statistically significant from 31-60 and 61-90 min, respectively (P < 0.05 and P < 0.01). Objective and subjective determinants in the different time intervals were well correlated. Improvement of nasal congestion was observed in A at 91-120 min, as measured by nasal peak flow.

Topics: Administration, Oral; Adult; Conjunctivitis, Allergic; Double-Blind Method; Female; Histamine H1 Antagonists; Humans; Male; Middle Aged; Pollen; Rhinitis, Allergic, Seasonal; Triprolidine

Acrivastine is a short acting histamine H1-receptor antagonist with a rapid onset of action. Double-blind clinical trials have shown acrivastine (usually 8mg three times daily) to be an effective and well tolerated antihistamine in the treatment of chronic urticaria and allergic rhinitis. Acrivastine was more effective than placebo and similar in efficacy to clemastine or terfenadine in the treatment of seasonal allergic rhinitis. In the treatment of dermatoses in which histamine has a pathogenetic role, the efficacy of acrivastine was superior to that of placebo and similar to that of usual dosages of clemastine, hydroxyzine, chlorpheniramine, cyproheptadine or terfenadine. Acrivastine caused less drowsiness than clemastine, the incidence of adverse effects being indistinguishable from that with placebo or terfenadine. Thus, acrivastine is an effective addition to drugs currently available for the treatment of patients with allergic diseases in whom a histamine H1-receptor antagonist is indicated. Because of its rapid onset of action acrivastine will be particularly useful for 'on demand' therapy in patients with intermittent symptoms.

Topics: Dermatitis, Atopic; Histamine H1 Antagonists; Humans; Rhinitis, Allergic, Seasonal; Triprolidine; Urticaria

In a four period, double-blind cross-over study, forty patients with moderate to severe symptoms of seasonal allergic rhinitis received in randomised order 8 mg acrivastine, 60 mg pseudoephedrine, 8 mg acrivastine plus 60 mg pseudoephedrine and placebo. Each treatment was given three times daily for six days with a one day washout period between treatments. Acrivastine alone significantly reduced all the symptom severity scores when compared to placebo or pseudoephedrine alone (p less than 0.01). These severity scores were assigned daily by patients for itchy nose/throat, sneezing, running nose, blocked nose, watery eyes, itchy eyes and overall symptoms. The combination of acrivastine and pseudoephedrine was significantly better than either placebo or pseudoephedrine alone in controlling all symptom scores (p less than 0.01) and it was also superior to acrivastine alone (p less than 0.05) in controlling all symptoms except itchy eyes. The results confirm the expected additive rather than synergistic effect of acrivastine and pseudoephedrine in combination. The control of symptoms assessed at the end of each treatment period was considered either excellent or good by 79% of patients and 84% of investigators for acrivastine plus pseudoephedrine and, for acrivastine alone, by 69% of patients and 67% of investigators. Both acrivastine alone and acrivastine and pseudoephedrine in combination were well tolerated. There was no significant difference in the number of adverse experiences reported in either of these two groups compared to the number of adverse experiences reported in the placebo group.

Topics: Adolescent; Adult; Double-Blind Method; Drug Therapy, Combination; Ephedrine; Female; Histamine H1 Antagonists; Humans; Male; Middle Aged; Pyridines; Rhinitis, Allergic, Seasonal; Triprolidine

In a double-blind, placebo-controlled multicentre study, the antihistamine acrivastine, was used over prolonged periods for the treatment of seasonal allergic rhinitis. After the initial treatment period of 10 days, 8 mg acrivastine three times daily was significantly superior to placebo in controlling the symptoms of sneezing, itchy nose, running nose, watery eyes, itchy eyes and itchy throat. The benefit from acrivastine was also apparent in the second (14 days) and third (28 days) treatment periods, although the difference no longer reached statistical significance. This was probably due to the large proportion of non-responders in the placebo group who withdrew from the study owing to lack of efficacy. The investigators rated symptom control with acrivastine to be 'good' in comparison to 'poor' control with placebo treatment (P = 0.01) for all three periods. There were no significant differences between acrivastine and placebo in the incidence of adverse experiences at the end of each treatment period. Acrivastine is effective and well tolerated over prolonged periods (up to 52 days) for the treatment of seasonal allergic rhinitis.

Topics: Adult; Clinical Trials as Topic; Double-Blind Method; Female; Histamine H1 Antagonists; Humans; Male; Multicenter Studies as Topic; Pyridines; Rhinitis, Allergic, Seasonal; Triprolidine

Acrivastine is an antihistamine with reduced sedating potential. This comprehensive review of clinical experience with acrivastine in allergic rhinitis considers all currently available data both published and, as yet, unpublished. Unequivocal evidence of the efficacy of 8 mg acrivastine three times daily for the control of symptoms of seasonal allergic rhinitis has been provided by 11 placebo-controlled studies involving almost 1000 patients. Additional trials have generated further supportive data as well as evidence for the use of acrivastine in the treatment of perennial allergic rhinitis. In common with most antihistamines, acrivastine alone has limited effect on the symptom of blocked nose. In a further series of 11 studies, mainly conducted in the USA, the combination of 8 mg acrivastine plus 60 mg pseudoephedrine was found to control not only the histamine-mediated symptoms of allergic rhinitis but also blocked nose. There were few adverse events associated with the use of acrivastine and the small increase in incidence of drowsiness over that found with placebo was similar to that observed for terfenadine. The marked absence of other signs of significant depression of the central nervous system (or anticholinergic activity) suggests that acrivastine will be an important addition for the antihistaminic control of symptoms of allergic rhinitis.

Topics: Clinical Trials as Topic; Histamine H1 Antagonists; Humans; Pyridines; Rhinitis, Allergic, Seasonal; Triprolidine

In this double-blind, multicentre study the antihistamine acrivastine was compared with terfenadine for the treatment of seasonal allergic rhinitis. The study was divided into three periods which together lasted 56 days. Patients (n = 83) were randomly assigned treatment with either 8 mg acrivastine three times daily or 60 mg terfenadine twice daily. Both agents were equally efficacious in reducing the severity of sneezing, itchy nose, blocked nose, running nose, itchy eyes, watery eyes and itchy throat as recorded daily by patients, and as rated by both the patients and their physicians at the end of each treatment period. Acrivastine and terfenadine were equally well tolerated with no serious side-effects. Both effectively controlled the symptoms of seasonal allergic rhinitis in otherwise healthy individuals.

Topics: Adult; Benzhydryl Compounds; Clinical Trials as Topic; Double-Blind Method; Female; France; Histamine H1 Antagonists; Humans; Male; Multicenter Studies as Topic; Pyridines; Random Allocation; Rhinitis, Allergic, Seasonal; Terfenadine; Triprolidine

In a placebo controlled, randomised, multicentre study the efficacy and safety of multiple doses of acrivastine, a derivative of the antihistamine tripolidine (Actidil) were evaluated in patients exhibiting symptoms of seasonal allergic rhinitis. Over the 10 day treatment period, 103 patients received, twice daily, either 4 mg and 8 mg of acrivastine or a placebo. Three patients withdrew from the study due to poor symptom control and two due to adverse experiences. The reporting of adverse experiences was evenly distributed between the treatment and placebo periods. Acrivastine did not affect the haematological, biochemical or urinalysis screens. Both 4 mg and 8 mg acrivastine alleviated the symptoms of seasonal allergic rhinitis with significant improvements in the symptom scores for sneezing, running nose and the calculated overall score. In addition, 8 mg acrivastine reduced the symptom scores for watery eyes and itchy throat. Acrivastine was both well tolerated and effective in the treatment of seasonal allergic rhinitis.

Topics: Adolescent; Adult; Female; Histamine H1 Antagonists; Humans; Male; Middle Aged; Multicenter Studies as Topic; Pyridines; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Seasonal; Triprolidine

Topics: Drug Combinations; Ephedrine; Histamine H1 Antagonists; Humans; Rhinitis, Allergic, Seasonal; Triprolidine

Topics: Drug Combinations; Ephedrine; Histamine H1 Antagonists; Humans; Rhinitis, Allergic, Seasonal; Triprolidine