Nasal Spray

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H Sacks - One of the best experts on this subject based on the ideXlab platform.

  • double blind placebo controlled study of azelastine and fluticasone in a single Nasal Spray delivery device
    Annals of Allergy Asthma & Immunology, 2010
    Co-Authors: Frank C Hampel, Paul H Ratner, Julius Van Bavel, Niran J Amar, Pramila Daftary, William Wheeler, H Sacks
    Abstract:

    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.

  • 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, 2008
    Co-Authors: Paul H Ratner, Frank C Hampel, Julius Van Bavel, Niran J Amar, Pramila Daftary, William Wheeler, H Sacks
    Abstract:

    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.

  • 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, 2006
    Co-Authors: William E. Berger, Frank C Hampel, H Sacks, Jonathan A Bernstein, Shailen Shah, Eli O. Meltzer
    Abstract:

    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.

  • effectiveness of azelastine Nasal Spray compared with oral cetirizine in patients with seasonal allergic rhinitis
    Clinical Therapeutics, 2005
    Co-Authors: Jonathan Corren, William E. Berger, William W Storms, Jonathan A Bernstein, Anjuli Nayak, H Sacks
    Abstract:

    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.

William E. Berger - One of the best experts on this subject based on the ideXlab platform.

  • 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, 2006
    Co-Authors: William E. Berger, Frank C Hampel, H Sacks, Jonathan A Bernstein, Shailen Shah, Eli O. Meltzer
    Abstract:

    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.

  • effectiveness of azelastine Nasal Spray compared with oral cetirizine in patients with seasonal allergic rhinitis
    Clinical Therapeutics, 2005
    Co-Authors: Jonathan Corren, William E. Berger, William W Storms, Jonathan A Bernstein, Anjuli Nayak, H Sacks
    Abstract:

    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.

  • efficacy of azelastine Nasal Spray in patients with an unsatisfactory response to loratadine
    Annals of Allergy Asthma & Immunology, 2003
    Co-Authors: William E. Berger, Martha V White
    Abstract:

    Objective To evaluate the effectiveness and safety of azelastine Nasal Spray, desloratadine, and the combination of azelastine Nasal Spray plus loratadine compared with placebo in patients with seasonal allergic rhinitis who had an unsatisfactory response to loratadine. Methods This was a 2-week, multicenter, placebo-controlled, randomized, double-blind study in patients with moderate-to-severe symptoms of seasonal allergic rhinitis. Following a 1-week, open-label lead-in period, during which the patients received loratadine 10 mg daily, those patients who met the symptom qualification criteria ( Results A total of 428 patients with an unsatisfactory response to loratadine completed the double-blind treatment period. After 2 weeks of treatment, azelastine Nasal Spray ( P P P = 0.039) significantly improved the total Nasal symptom score compared with placebo. Conclusions Azelastine Nasal Spray is an effective treatment for patients with seasonal allergic rhinitis who do not respond to loratadine and is an alternative to switching to another oral antihistamine or to using multiple antihistamines.

  • Double-blind trials of azelastine Nasal Spray monotherapy versus combination therapy with loratadine tablets and beclomethasone Nasal Spray in patients with seasonal allergic rhinitis
    Annals of Allergy Asthma & Immunology, 1999
    Co-Authors: William E. Berger, Stanley M. Fineman, Phillip Lieberman, Robert M. Miles
    Abstract:

    Background Azelastine hydrochloride is an H 1 -receptor antagonist with anti-inflammatory properties that is available in the US as Astelin Nasal Spray for the treatment of seasonal allergic rhinitis. The symptoms of seasonal allergic rhinitis can initially be treated with monotherapy using either an antihistamine or an intraNasal corticosteroid. Patients whose symptoms do not respond adequately are often prescribed a combination of both an antihistamine and an intraNasal corticosteroid. Objective Three multicenter, randomized, double-blind studies were conducted to determine whether patients with moderate-to-severe symptoms of seasonal allergic rhinitis who had responded inadequately to monotherapy with either an oral antihistamine or an intraNasal corticosteroid, and who were candidates for combination therapy with both an oral antihistamine and an intraNasal corticosteroid, could be effectively treated with azelastine Nasal Spray monotherapy. Methods Following a 1- to 2-week washout period, patients were randomized to 7 days of double-blind treatment with either azelastine Nasal Spray (2 Sprays per nostril bid, 1.1 mg/day) monotherapy or combination therapy with oral loratadine (Claritin, one 10-mg tablet/day) plus intraNasal beclomethasone dipropionate monohydrate (Beconase AQ, 2 Sprays per nostril bid, 336 μg/day). Efficacy was determined at the end of the study by both a physician assessment of the need for additional anti-rhinitis medication and a patient global evaluation of therapeutic effectiveness. The three studies were conducted at 71 investigational sites during the 1998 spring allergy season. Three separate studies were conducted to verify the reproducibility of the new study design. Results In all three studies a total of 1,070 patients were randomized to double-blind treatment. There were no statistically significant differences in the percentage of patients treated with azelastine Nasal Spray versus patients treated with a combination of loratadine tablets and beclomethasone Nasal Spray who did not require additional anti-rhinitis medication (32% to 45% and 39% to 46%, respectively). The patient global evaluation indicated that 77% to 84% of the patients treated with azelastine Nasal Spray had symptomatic improvement and 85% to 90% of the patients treated with loratadine tablets and beclomethasone Nasal Spray had symptomatic improvement. The most commonly reported adverse experience with azelastine Nasal Spray was a transient aftertaste (8%), while the most commonly reported adverse experience with loratadine tablets and beclomethasone Nasal Spray in combination was headache (6%). Conclusions Based on the percentage of patients not requiring additional anti-rhinitis medication and the patient assessment of efficacy, azelastine Nasal Spray monotherapy was as effective as the combination of oral loratadine plus intraNasal beclomethasone in treating moderate-to-severe symptoms of seasonal allergic rhinitis.

Narayanan Prepageran - One of the best experts on this subject based on the ideXlab platform.

Frank C Hampel - One of the best experts on this subject based on the ideXlab platform.

  • double blind placebo controlled study of azelastine and fluticasone in a single Nasal Spray delivery device
    Annals of Allergy Asthma & Immunology, 2010
    Co-Authors: Frank C Hampel, Paul H Ratner, Julius Van Bavel, Niran J Amar, Pramila Daftary, William Wheeler, H Sacks
    Abstract:

    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.

  • 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, 2008
    Co-Authors: Paul H Ratner, Frank C Hampel, Julius Van Bavel, Niran J Amar, Pramila Daftary, William Wheeler, H Sacks
    Abstract:

    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.

  • 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, 2006
    Co-Authors: William E. Berger, Frank C Hampel, H Sacks, Jonathan A Bernstein, Shailen Shah, Eli O. Meltzer
    Abstract:

    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.

  • Improved quality of life (QoL) among seasonal allergic rhinitis (SAR) patients treated with olopatadine HCl Nasal Spray, 0.4% and olopatadine HCl Nasal Spray, 0.6% compared to vehicle
    The Journal of Allergy and Clinical Immunology, 2004
    Co-Authors: Frank C Hampel, Paul H Ratner, Niran J Amar, M. Brubaker, M. Drake, J.h. Van Bavel, Dale Mohar, K. Venkataraman, G.m. Wall, K. Crenshaw
    Abstract:

    Abstract Rationale Since SAR causes a considerable impact on QoL, the Rhinoconjunctivitis Quality of Life (RQLQ) Questionnaire was used to assess the QoL impact of olopatadine HCl Nasal Spray compared to the vehicle. Methods The 28-item RQLQ, consisting of 7 domains (activities, sleep, non-hayfever symptoms, practical problems, Nasal symptoms, eye symptoms, and emotional), was used to collect QoL data during a multicenter, randomized, double-masked SAR (mountain cedar) trial comparing olopatadine HCl Nasal Spray, 0.6% and 0.4% against the olopatadine vehicle. Patients, recruited with at least a 2-yr history of non-recalcitrant SAR, filled out the questionnaire at baseline (randomization visit), and again after 2 weeks at the exit (end of treatment) visit. Results Olopatadine 0.6% (−1.1 + −1.4) and 0.4% (−1.1 + −1.3) Nasal Sprays were superior (p Conclusions Both olopatadine HCl Nasal Sprays are superior to vehicle in improving overall QoL. While patients receiving olopatadine HCl Nasal Spray, 0.6% had significantly demonstrable improvement in all areas of their life except non-hayfever symptoms, patients receiving olopatadine 0.4% Nasal Spray had significant improvement in 5 out of the 7 total QoL areas.

Balachandran Arvin - One of the best experts on this subject based on the ideXlab platform.