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Phil Lieberman - One of the best experts on this subject based on the ideXlab platform.
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long term randomized safety study of mp29 02 a novel intranasal formulation of Azelastine hydrochloride and fluticasone propionate in an advanced delivery system in subjects with chronic rhinitis
The Journal of Allergy and Clinical Immunology: In Practice, 2014Co-Authors: William E. Berger, Ullrich Munzel, Shailen Shah, Phil Lieberman, David Price, James A Hadley, Sanjay BhatiaAbstract:Background MP29-02 is a novel intranasal formulation of Azelastine hydrochloride and fluticasone propionate (FP) in an advanced delivery system for the treatment of seasonal allergic rhinitis. Objective The objective of this study was to evaluate the long-term safety of MP29-02 in subjects with chronic allergic (perennial) or nonallergic (vasomotor) rhinitis. Methods This was a 1-year, randomized, open-label, active-controlled, parallel-group study in subjects with chronic allergic or nonallergic rhinitis. A total of 612 subjects were randomized in a 2:1 ratio to (1) MP29-02, one spray per nostril twice daily (total daily doses of Azelastine hydrochloride and FP were 548 mcg and 200 mcg, respectively); or (2) FP, 2 sprays per nostril once daily (total daily dose 200 mcg). Safety and tolerability assessments were made at months 1, 3, 6, 9, and 12. Results The incidence of treatment-related adverse events was low with both MP29-02 (9.4%) and FP (11.1%), with no evidence of late-occurring adverse events. Nasal examinations showed no evidence of nasal mucosal ulcerations or septal perforations with MP29-02, and the overall incidence of adverse findings was reduced as the study progressed. There were no unusual or unexpected ocular examination findings and no clinically important laboratory findings or clinically important differences between groups in fasting AM serum cortisol levels after 12 months of treatment. Conclusions MP29-02 was well tolerated. There were no safety findings that would preclude the long-term use of MP29-02 in the treatment of allergic rhinitis.
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a novel intranasal therapy of Azelastine with fluticasone for the treatment of allergic rhinitis
The Journal of Allergy and Clinical Immunology, 2012Co-Authors: W Carr, Ullrich Munzel, Jonathan A. Bernstein, Eli O. Meltzer, Claus Bachert, Phil Lieberman, D Price, Jean BousquetAbstract:Background Moderate-to-severe allergic rhinitis (AR) is a challenge to treat, with many patients using multiple therapies and achieving limited symptom control. More effective therapies must be developed and tested in well-controlled, randomized, prospective studies with a direct comparison to current standards. Objectives The aim of these studies was to investigate the efficacy of MP29-02 (a novel formulation of Azelastine and fluticasone propionate [FP]) in patients with moderate-to-severe seasonal allergic rhinitis (SAR) and to compare its efficacy with 2 first-line therapies (ie, intranasal Azelastine and intranasal FP) in this population. Methods Three thousand three hundred ninety-eight patients (≥12 years old) with moderate-to-severe SAR were enrolled into 3 multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trials (MP4002 [NCT00651118], MP4004 [NCT00740792], and MP4006 [NCT00883168]). Each trial was conducted for 14 days during different allergy seasons. The primary efficacy variable was the sum of the morning and evening change from baseline in reflective total nasal symptom score (range, 0-24) over the treatment period. Outcomes for the meta-analysis included efficacy according to disease severity and time to response in relevant responder criteria. Results In the meta-analysis MP29-02 reduced the mean reflective total nasal symptom score from baseline (−5.7 [SD, 5.3]) more than FP (−5.1 [SD, 4.9], P P P Conclusions MP29-02 represents a novel therapy that demonstrated superiority to 2 first-line therapies for AR. Patients with moderate-to-severe SAR achieved better control, and their symptoms were controlled earlier with MP29-02 than with recommended medications according to guidelines.
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open label evaluation of Azelastine nasal spray in patients with seasonal allergic rhinitis and nonallergic vasomotor rhinitis
Current Medical Research and Opinion, 2005Co-Authors: Phil Lieberman, Michael A Kaliner, William WheelerAbstract:ABSTRACTObjective: The objective of the study was to evaluate the effectiveness of Azelastine (Astelin) nasal spray, a topical second-generation antihistamine, in the treatment of symptoms of seasonal allergic rhinitis, seasonal allergic rhinitis with nonallergic triggers (mixed rhinitis), and nonallergic vasomotor rhinitis. † Astelin is a registered trade name of MedPointe Pharmaceuticals, Somerset, NJResearch design and methods: A total of 2343 primary care physicians, allergists, ENT specialists, and other health professionals participated in this 2-week, open-label evaluation of Azelastine nasal spray. Data were collected through a physician questionnaire that included patient demographics, rhinitis diagnosis, medication history, and inclusion/exclusion criteria; and two patient questionnaires that included symptom history, response to previous rhinitis medications, symptom control, and level of satisfaction with Azelastine nasal spray. A completed physician questionnaire and two completed patient que...
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efficacy of Azelastine nasal spray in the treatment of vasomotor perennial nonallergic rhinitis
Annals of Allergy Asthma & Immunology, 2001Co-Authors: Charles H Banov, Phil LiebermanAbstract:Background Azelastine hydrochloride is an antihistamine with anti-inflammatory properties that is available in the United States in a nasal spray formulation for the treatment of seasonal allergic rhinitis. Vasomotor (perennial nonallergic) rhinitis (VMR) is a noninfectious, chronic rhinitis usually not associated with inflammatory cell infiltration. Objective Two multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trials were conducted to determine whether patients with symptoms of VMR (rhinorrhea, sneezing, postnasal drip, and nasal congestion) could be effectively treated with Azelastine nasal spray. Methods All of the patients who participated in the trials had a diagnosis of VMR, symptoms for at least 1 year, negative skin tests for a mixed panel of seasonal and perennial allergens, and a nasal cytology examination negative for eosinophils. After a 1-week, single-blind, placebo lead-in period, patients who met the symptom severity qualification criteria were randomized to receive either Azelastine nasal spray (two sprays per nostril twice daily, 1.1 mg/day) or placebo nasal spray for 21 days. Patients recorded the severity of their VMR symptoms on diary cards each morning and evening of the trial using a four-point symptom rating scale (0 = none to 3=severe). The primary efficacy variable was the overall reduction from baseline in the total vasomotor rhinitis symptom score (TVRSS) over the 21-day, double-blind treatment period. Results In both studies, Azelastine nasal spray significantly (study 1, P = .002; study 2, P = .005) reduced the TVRSS from baseline when compared with placebo. Significant improvement was observed within the first week and improvement in all symptoms favored treatment with Azelastine nasal spray. No serious or unexpected adverse events were reported in either study. Bitter taste (19% vs 2%) was the only adverse experience that occurred with a statistically significantly greater incidence in the Azelastine group than in the placebo group. Conclusions This is the first demonstration of the efficacy of an antihistamine in the therapy of VMR in two double-blind, placebo-controlled clinical trials.
U Petzold - One of the best experts on this subject based on the ideXlab platform.
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Azelastine nasal spray and desloratadine tablets in pollen induced seasonal allergic rhinitis a pharmacodynamic study of onset of action and efficacy
Current Medical Research and Opinion, 2006Co-Authors: Friedrich Horak, Alexander Kavina, Ullrich Munzel, René Zieglmayer, Ursula Petra Zieglmayer, Karin Marschall, U PetzoldAbstract:ABSTRACTObjective: To assess the efficacy and onset of action of Azelastine nasal spray and desloratadine tablets in patients with allergen-induced seasonal allergic rhinitis (SAR).Research design and methods: 46 adult patients with a history of SAR were exposed to a controlled grass pollen concentration for 6 h in the Vienna Challenge Chamber (VCC) in each treatment period according to a randomised, double-blind (double-dummy), three-period, three-sequence crossover design (wash-out period of 12 days). Single doses of study medication (one puff nasal spray into each nostril of Azelastine, 0.28 mg, or placebo before swallowing one encapsulated tablet of desloratadine, 5 mg) were administered 2 h after the start of the allergen challenge. Results of subjective and objective assessments were recorded throughout the challenge.Results: Efficacy of Azelastine nasal spray was significantly superior compared to desloratadine tablets ( p = 0.005) and placebo ( p < 0.001). Desloratadine was significantly better th...
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comparison of the efficacy and tolerability of topically administered Azelastine sodium cromoglycate and placebo in the treatment of seasonal allergic conjunctivitis and rhino conjunctivitis
Current Medical Research and Opinion, 2003Co-Authors: I G V James, J M Harrison, P J Fell, Barbara Ellerslenz, L M Campbell, U PetzoldAbstract:SUMMARYObjective and setting: Azelastine (AZE) in a novel, eye drop, formulation, was compared with topically applied sodium cromoglycate (SCG) and placebo (PLA) in the treatment of seasonal allergic conjunctivitis or rhino-conjunctivitis in a multicentre, parallel group study.Research design: 144 subjects ranging in age from 16 to 65 years participated. All had at least a 2-year history of seasonal allergic conjunctivitis and were symptomatic at the time of inclusion.Medications were administered topically either twice daily (AZE/PLA) or four times daily (SCG) over a 2-week treatment period.Method and outcome measures: Azelastine and placebo were compared double-blind; the comparison versus SCG was carried out in an open manner. Itching, redness, flow of tears, eyelid swelling, foreign-body sensation, photophobia, soreness and discharge were scored on a 4-point severity scale.Results: Results for the decrease of main conjunctivitis symptoms (itching, tearing and conjunctival redness) showed a marked effe...
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comparison of Azelastine eye drops with levocabastine eye drops in the treatment of seasonal allergic conjunctivitis
Current Medical Research and Opinion, 2000Co-Authors: C Giede, U Petzold, P Metzenauer, Barbara EllerslenzAbstract:SummaryA randomised, multicentre parallel group study was undertaken to compare the efficacy and safety of 0.05% Azelastine eye drops (101 patients) in an open manner with 0.05% levocabastine eye drops (103 patients) and in a double-blind manner with placebo (103 patients) during a 14-day treatment period involving patients with seasonal allergic conjunctivitis. The three main eye symptoms, scored on a four-point scale, were itching, lacrimation and conjunctival redness; the primary efficacy variable was the responder rate on day 3. Responders were patients whose sum score of the three main eye symptoms decreased by at least three points from a baseline score of at least six points. In addition to these main symptoms, five other symptoms were recorded on days 0, 3, 7 and 14, and patients kept daily diaries of the three main eye symptoms and swollen eyelids. The responder rate after 3 days of treatment was 69% in patients treated with Azelastine, 59% in patients treated with levocabastine and 51% in the pl...
Barbara Ellerslenz - One of the best experts on this subject based on the ideXlab platform.
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Azelastine eye drops in the treatment of perennial allergic conjunctivitis
Drug Research, 2011Co-Authors: Ozod Nazarov, Barbara Ellerslenz, Ursula Petzold, Hans Haase, Duc Tung Nguyen, Robert HermannAbstract:Azelastine (CAS 58581-89-8) is a selective H1-receptor antagonist that inhibits histamine release and interferes with activation of other mediators of allergic inflammation. The present double-blind study aimed to evaluate Azelastine eye drops (Allergodil) in patients with perennial allergic conjunctivitis compared to placebo. A total of 116 patients with an ocular symptoms score for itching and conjunctival redness > or = 3 (0-6 scale) were randomized to twice-daily 0.05% Azelastine eye drops treatment (n = 58) or placebo. Patients maintained daily logs and were clinically evaluated after 7, 21 and 42 days of treatment. Azelastine significantly improved itching and conjunctival redness versus placebo (p or = 2 in 55% with Azelastine (versus 14% placebo). Itching and redness further improved at Day 42 (score improvement > or = 2 in 95% with Azelastine versus 33% placebo) and completely resolved for 47% Azelastine patients (versus 10% placebo). Daily patient logs confirmed the clinically assessed scores. Topical Azelastine progressively improved itching and conjunctival redness in patients with moderate to severe perennial allergic conjunctivitis. Continued improvement with prolonged use is consistent with mechanisms other than H1-receptor blockade, such as possible down regulation of adhesion molecule receptors.
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comparison of the efficacy and tolerability of topically administered Azelastine sodium cromoglycate and placebo in the treatment of seasonal allergic conjunctivitis and rhino conjunctivitis
Current Medical Research and Opinion, 2003Co-Authors: I G V James, J M Harrison, P J Fell, Barbara Ellerslenz, L M Campbell, U PetzoldAbstract:SUMMARYObjective and setting: Azelastine (AZE) in a novel, eye drop, formulation, was compared with topically applied sodium cromoglycate (SCG) and placebo (PLA) in the treatment of seasonal allergic conjunctivitis or rhino-conjunctivitis in a multicentre, parallel group study.Research design: 144 subjects ranging in age from 16 to 65 years participated. All had at least a 2-year history of seasonal allergic conjunctivitis and were symptomatic at the time of inclusion.Medications were administered topically either twice daily (AZE/PLA) or four times daily (SCG) over a 2-week treatment period.Method and outcome measures: Azelastine and placebo were compared double-blind; the comparison versus SCG was carried out in an open manner. Itching, redness, flow of tears, eyelid swelling, foreign-body sensation, photophobia, soreness and discharge were scored on a 4-point severity scale.Results: Results for the decrease of main conjunctivitis symptoms (itching, tearing and conjunctival redness) showed a marked effe...
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topical Azelastine in perennial allergic conjunctivitis
Current Medical Research and Opinion, 2003Co-Authors: Giorgio Walter Canonica, Barbara Ellerslenz, Ursula Petzold, Giorgio Ciprandi, C Kolb, Robert HermannAbstract:SUMMARYObjective: Azelastine is a selective H1-receptor antagonist that inhibits histamine release and interferes with activation of several other mediators of allergic inflammation. Together with demonstrated efficacy in seasonal allergic conjunctivitis, Azelastine indicated a therapeutic potential for perennial allergic conjunctivitis (PAC).The present study aimed to evaluate Azelastine eye drops in patients with PAC compared to placebo.Research design and methods: A multinational trial in 22 centres randomised 139 patients to twice-daily treatment for 6 weeks with masked 0.05% Azelastine eye drops, matching masked placebo, or open-label levocabastine. Randomisation required a sum itching and conjunctival redness score of at least 3 (0-6 scale) after 1 week of placebo. The change in sum score was evaluated during treatment.Results: Azelastine significantly improved itching and conjunctival redness compared to placebo (p < 0.001) with global tolerability that was not substantially different from placebo....
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comparison of Azelastine eye drops with levocabastine eye drops in the treatment of seasonal allergic conjunctivitis
Current Medical Research and Opinion, 2000Co-Authors: C Giede, U Petzold, P Metzenauer, Barbara EllerslenzAbstract:SummaryA randomised, multicentre parallel group study was undertaken to compare the efficacy and safety of 0.05% Azelastine eye drops (101 patients) in an open manner with 0.05% levocabastine eye drops (103 patients) and in a double-blind manner with placebo (103 patients) during a 14-day treatment period involving patients with seasonal allergic conjunctivitis. The three main eye symptoms, scored on a four-point scale, were itching, lacrimation and conjunctival redness; the primary efficacy variable was the responder rate on day 3. Responders were patients whose sum score of the three main eye symptoms decreased by at least three points from a baseline score of at least six points. In addition to these main symptoms, five other symptoms were recorded on days 0, 3, 7 and 14, and patients kept daily diaries of the three main eye symptoms and swollen eyelids. The responder rate after 3 days of treatment was 69% in patients treated with Azelastine, 59% in patients treated with levocabastine and 51% in the pl...
James H Day - One of the best experts on this subject based on the ideXlab platform.
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a four way double blind randomized placebo controlled study to determine the efficacy and speed of Azelastine nasal spray versus loratadine and cetirizine in adult subjects with allergen induced seasonal allergic rhinitis
Allergy Asthma & Clinical Immunology, 2013Co-Authors: James H Day, Anne K Ellis, Lisa M. Steacy, Yifei Zhu, Terry WalkerAbstract:Azelastine has been shown to be effective against seasonal allergic rhinitis (SAR). The Environmental Exposure Unit (EEU) is a validated model of experimental SAR. The objective of this double-blind, four-way crossover study was to evaluate the onset of action of Azelastine nasal spray, versus the oral antihistamines loratadine 10 mg and cetirizine 10 mg in the relief of the symptoms of SAR. 70 participants, aged 18-65, were randomized to receive Azelastine nasal spray, cetirizine, loratadine, or placebo after controlled ragweed pollen exposure in the EEU. Symptoms were evaluated using the total nasal symptom score (TNSS). The primary efficacy parameter was the onset of action as measured by the change from baseline in TNSS. Azelastine displayed a statistically significant improvement in TNSS compared with placebo at all time points from 15 minutes through 6 hours post dose. Azelastine, cetirizine, and loratadine reduced TNSS compared to placebo with an onset of action of 15 (p < 0.001), 60 (p = 0.015), and 75 (p = 0.034) minutes, respectively. The overall assessment of efficacy was rated as good or very good by 46% of the participants for Azelastine, 51% of the participants for cetirizine, and 30% of the participants for loratadine compared to 18% of the participants for placebo. Azelastine’s onset of action for symptom relief was faster than that of cetirizine and loratadine. The overall participant satisfaction in treatment with Azelastine is comparable to cetirizine and statistically superior to loratadine. These results suggest that Azelastine may be preferential to oral antihistamines for the rapid relief of SAR symptoms.
H Sacks - One of the best experts on this subject based on the ideXlab platform.
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double blind placebo controlled study of Azelastine and fluticasone in a single nasal spray delivery device
Annals of Allergy Asthma & Immunology, 2010Co-Authors: Frank C Hampel, Julius Van Bavel, Niran J Amar, Pramila Daftary, William Wheeler, Paul H Ratner, H SacksAbstract:Background A proof-of-concept study suggested that combination therapy with commercial Azelastine hydrochloride nasal spray and fluticasone propionate nasal spray significantly improved nasal symptoms of seasonal allergic rhinitis compared with either agent alone. Objective To compare an Azelastine-fluticasone combination nasal spray administered in a single-delivery device with a commercially available Azelastine nasal spray and fluticasone nasal spray. Methods This 14-day, multicenter, randomized, double-blind study was conducted during the Texas mountain cedar season. After a 5-day placebo lead-in, 610 patients with moderate-to-severe nasal symptoms were randomized to treatment with (1) Azelastine nasal spray, (2) fluticasone nasal spray, (3) combination Azelastine and fluticasone nasal spray, or (4) placebo nasal spray. All treatments were given as 1 spray per nostril twice daily. The primary efficacy variable was the change from baseline in the total nasal symptom score (TNSS), consisting of nasal congestion, runny nose, itchy nose, and sneezing. Results All 3 active groups were statistically superior ( P ≤ .02) to placebo, and the combination was statistically superior ( P ≤ .003) to either agent alone. The TNSS improved by 28.4% with combination Azelastine-fluticasone, 20.4% with fluticasone, 16.4% with Azelastine, and 11.2% with placebo. All 3 treatments were well tolerated. Conclusions The combination Azelastine-fluticasone nasal spray provided statistically significant improvement in the TNSS and additive clinical benefit compared with either agent alone in patients with moderate-to-severe seasonal allergic rhinitis. Trial Registration clinicaltrials.gov Identifier: NCT00660517.
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Efficacy and Safety of Azelastine 0.15% Nasal Spray and Azelastine 0.10% Nasal Spray in Patients with Seasonal Allergic Rhinitis
SAGE Publishing, 2010Co-Authors: Shailen Shah, William Wheeler, William Berger, William Lumry, Craig La Force, H SacksAbstract:Azelastine is a second-generation antihistamine approved for treatment of allergic rhinitis. This randomized, double-blind, placebo- and active-controlled, parallel-group clinical trial evaluated the efficacy and safety of Azelastine 0.15% and Azelastine 0.10% nasal spray at a dosage of 2 sprays/nostril twice daily in patients with moderate-to-severe seasonal allergic rhinitis (SAR). In total, 526 patients were randomized 1:1:1 to treatment with 2 sprays/nostril twice daily of Azelastine 0.15%, Azelastine 0.10%, or placebo. The primary efficacy variable was change from baseline in 12-hour reflective Total Nasal Symptom Score (TNSS; A.M. and P.M. combined), consisting of nasal congestion, rhinorrhea, itchy nose, and sneezing. After 2 weeks, the mean improvement and percentage improvement in the 12-hour reflective TNSS were significant (p < 0.001) with Azelastine 0.15% and Azelastine 0.10% compared with placebo. In a retrospective analysis, there was a statistical difference (p = 0.047) in the mean improvement versus placebo in the 12-hour reflective TNSS with Azelastine 0.15% compared with Azelastine 0.10%. Onset of action with Azelastine 0.15% was within 30 minutes. Bitter taste was the most common adverse event with both Azelastine 0.15% and Azelastine 0.10% (8.4% and 9.4% of patients, respectively). Somnolence was reported by 1.7% of patients treated with Azelastine 0.15%, 0.6% of patients treated with Azelastine 0.10%, and 0.6% of patients treated with placebo. Azelastine 0.15% nasal spray at 2 sprays/nostril twice daily significantly improved the nasal symptoms associated with SAR with an onset of action within 30 minutes and was well tolerated
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combination therapy with Azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in the treatment of patients with seasonal allergic rhinitis
Annals of Allergy Asthma & Immunology, 2008Co-Authors: Paul H Ratner, Frank C Hampel, Julius Van Bavel, Niran J Amar, Pramila Daftary, William Wheeler, H SacksAbstract:Background To our knowledge, there are no published studies that evaluated the efficacy of Azelastine hydrochloride nasal spray in combination with an intranasal corticosteroid, although anecdotal reports of the use of these agents in combination are common. Objective To determine if greater efficacy could be achieved with the intranasal antihistamine Azelastine and the intranasal corticosteroid fluticasone propionate used concurrently compared with the efficacy of each agent alone. Methods This randomized, 2-week, multicenter, double-blind trial was conducted during the Texas mountain cedar season. After a 5-day placebo lead-in period, 151 patients with moderate to severe nasal symptoms were randomized to treatment with the following: (1) Azelastine nasal spray, 2 sprays per nostril twice daily; (2) fluticasone nasal spray, 2 sprays per nostril once daily; or (3) Azelastine nasal spray, 2 sprays per nostril twice daily, plus fluticasone nasal spray, 2 sprays per nostril once daily. The primary efficacy variable was the change from baseline in the total nasal symptom score (TNSS), consisting of sneezing, itchy nose, runny nose, and nasal congestion. Results All 3 groups had statistically significant ( P P Conclusions The significant improvement in the TNSS with combination therapy relative to the individual agents alone is in contrast to previously published studies that found no advantage with an oral antihistamine and an intranasal corticosteroid in combination. Azelastine nasal spray and fluticasone nasal spray in combination may provide a substantial therapeutic benefit for patients with seasonal allergic rhinitis compared with therapy with either agent alone.
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impact of Azelastine nasal spray on symptoms and quality of life compared with cetirizine oral tablets in patients with seasonal allergic rhinitis
Annals of Allergy Asthma & Immunology, 2006Co-Authors: William E. Berger, Frank C Hampel, H Sacks, Shailen Shah, Jonathan A. Bernstein, Eli O. MeltzerAbstract:Background In fall 2004, the first Azelastine Cetirizine Trial demonstrated statistically significant improvements in the total nasal symptom score (TNSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores with the use of Azelastine nasal spray vs oral cetirizine in patients with seasonal allergic rhinitis (SAR). Objective To compare the effects of Azelastine nasal spray vs cetirizine on the TNSS and RQLQ scores in patients with SAR. Methods This 2-week, double-blind, multicenter trial randomized 360 patients with moderate-to-severe SAR to Azelastine, 2 sprays per nostril twice daily, or cetirizine, 10-mg tablets once daily. The primary efficacy variable was the 12-hour reflective TNSS (rhinorrhea, sneezing, itchy nose, and nasal congestion). Secondary efficacy variables were individual symptom scores and the RQLQ score. Results Azelastine nasal spray and cetirizine significantly improved the TNSS and individual symptoms compared with baseline ( P P = .002) and individual domain ( P Conclusions Azelastine nasal spray and cetirizine effectively treated nasal symptoms in patients with SAR. Improvements in the TNSS and individual symptoms favored Azelastine over cetirizine, with significant differences for nasal congestion and sneezing. Azelastine nasal spray significantly improved the RQLQ overall and domain scores compared with cetirizine.
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effectiveness of Azelastine nasal spray compared with oral cetirizine in patients with seasonal allergic rhinitis
Clinical Therapeutics, 2005Co-Authors: Jonathan Corren, William W Storms, William E. Berger, Jonathan A. Bernstein, Anjuli Nayak, H SacksAbstract:Abstract Background: Azelastine nasal spray and oral cetirizine are selective histamine H 1 -receptor antagonists that are approved in the United States for the treatment of seasonal allergic rhinitis (SAR). Objective: The objective of the present study was to compare the efficacy and tolerability of Azelastine nasal spray administered at the recommended dosage of 2 sprays per nostril twice daily with those of cetirizine in the treatment of moderate to severe SAR. Methods: This multicenter, randomized, double-blind, parallel-group, 2-week comparative study was conducted during the 2004 fall allergy season in patients with moderate to severe SAR. After a 1-week placebo lead-in period, patients were randomized to receive Azelastine nasal spray 2 sprays per nostril twice daily plus placebo tablets or cetirizine 10-mg tablets once daily plus a placebo saline nasal spray for the 2-week double-blind treatment period. The primary efficacy variables were (1) change from baseline to day 14 in the 12-hour reflective total nasal symptom score (TNSS), which combines scores for rhinorrhea, sneezing, itchy nose, and nasal congestion, and (2) onset of action, based on the instantaneous TNSS over 4 hours after the first dose of study drug. During the double-blind treatment period, patients recorded their symptom scores on diary cards twice daily (morning and evening). Patients aged ≥18 years also completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at baseline and on day 14. Results: Three hundred seven patients were randomized to treatment, and 299 completed 2 weeks of study treatment. The age of the population ranged from 12 to 74 years (mean, 35 years), 62.9% were female, and 69.6% were white. Over 2 weeks of treatment, both groups had significant improvements in the TNSS compared with baseline ( P P = 0.015). In terms of onset of action, Azelastine nasal spray significantly improved the instantaneous TNSS compared with cetirizine at 60 and 240 minutes after the initial dose (both, P = 0.040). Scores on each domain of the RQLQ were significantly improved in both groups compared with baseline ( P P = 0.049). Both treatments were well tolerated. Conclusion: In this 2-week study in patients with moderate to severe SAR, Azelastine nasal spray was well tolerated and produced significantly greater improvements in TNSS and total RQLQ score compared with cetirizine.
