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Harold B Kaiser - One of the best experts on this subject based on the ideXlab platform.
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ipratropium bromide nasal spray 0 03 and beclomethasone nasal spray alone and in combination for the treatment of rhinorrhea in Perennial Rhinitis
Annals of Allergy Asthma & Immunology, 1999Co-Authors: Robert J Dockhorn, Donald W Aaronson, Edwin Bronsky, Paul Chervinsky, Robert M Cohen, Reza Ehtessabian, Albert F Finn, Jay Grossman, William C Howland, Harold B KaiserAbstract:Background Perennial Rhinitis is a common condition that affects up to 10% to 20% of the population. Multiple agents are frequently administered since no single agent provides complete relief. Studies assessing the benefit/risk of combined therapy are important especially for newly approved agents such as ipratropium bromide nasal spray 0.03%, a topical anticholinergic agent, approved specifically for the treatment of rhinorrhea in allergic and non-allergic Perennial Rhinitis. Objective To compare the efficacy and safety of the combined use of ipratropium bromide nasal spray 0.03% (42 μg per nostril tid) and beclomethasone dipropionate nasal spray (84 μg per nostril bid) against that of either active agent alone for the treatment of rhinorrhea. Design Multicenter, 6-week, double-blind, randomized active- and placebo-controlled, parallel trial. Setting Allergist and general practitioner clinical practices. Patients Five hundred thirty-three patients with Perennial Rhinitis (279 allergic and 274 non-allergic), 8 to 75 years of age, who had at least a mild degree of severity of rhinorrhea for a minimum of 2 hours per day during the 1 week screening period as well as congestion or sneezing also of at least mild severity. Intervention Either (1) ipratropium bromide nasal spray 0.03% (42 μg per nostril tid) plus beclomethasone dipropionate nasal spray (84 μg per nostril bid), (2) ipratropium bromide nasal spray 0.03% (42 μg per nostril tid) alone, (3) beclomethasone dipropionate nasal spray (84 μg per nostril bid) alone, or (4) vehicle [matching placebo nasal spray for the ipratropium bromide (2 sprays per nostril tid)] or beclomethasone dipropionate (2 sprays per nostril bid). Main Outcome Measure Severity and duration of rhinorrhea, and patient and physician global assessment of control of rhinorrhea. Results Ipratropium bromide nasal spray plus beclomethasone nasal spray was more effective than either active agent alone or vehicle in reducing the average severity and duration of rhinorrhea during 4 weeks of treatment. The advantage of ipratropium bromide plus beclomethasone nasal spray was evident by the first day of combined treatment and continued throughout the 2-week treatment period. Ipratropium bromide nasal spray had a faster onset of action during the first week of treatment and reduced the duration of rhinorrhea more than beclomethasone. Beclomethasone nasal spray was more effective in reducing the severity of congestion and sneezing than ipratropium. In patients who had not responded well to a nasal steroid prior to participation in the study based on a questionnaire administered at screening, ipratropium bromide was as effective in the steroid non-responders as steroid responders, whereas beclomethasone was more effective in steroid responders. Combined active therapy was well tolerated with no increase in adverse events over that seen previously with ipratropium bromide or beclomethasone nasal spray alone. Conclusions The combined use of ipratropium bromide nasal spray with beclomethasone dipropionate nasal spray is more effective than either active agent for the treatment of rhinorrhea, and does not result in a potentiation of adverse drug reactions. Ipratropium bromide nasal spray 0.03% alone should be considered in patients for whom rhinorrhea is the primary symptom, and its use in combination with a nasal steroid should be considered in patients where rhinorrhea is one of the predominant symptoms, or in patients with rhinorrhea not fully responsive to other therapy.
I S Mackay - One of the best experts on this subject based on the ideXlab platform.
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assessment by nasal biopsy of long term use of mometasone furoate aqueous nasal spray nasonex in the treatment of Perennial Rhinitis
Otolaryngology-Head and Neck Surgery, 1998Co-Authors: E Minshall, Valerie J Lund, Omar Ghaffar, L Cameron, F Obrien, H Quinn, Julian Rowejones, R J Davies, A Prior, I S MackayAbstract:Abstract Allergic Rhinitis is associated with specific histopathologic changes in the nasal mucosa including squamous metaplasia and local eosinophilia. Previous studies have shown that mometasone furoate aqueous nasal spray is effective and well tolerated in reducing Perennial Rhinitis and seasonal allergic Rhinitis symptoms. We undertook a multicenter, open-label study to evaluate, by nasal biopsy, the tissue changes associated with mometasone furoate use (200 μg/day) during a 12-month treatment period in patients with Perennial Rhinitis. Of the 69 patients enrolled in the study, 52 completed all 12 months of treatment. Nasal biopsy specimens obtained from patients at baseline and after treatment were evaluated in a blinded fashion by computerized image analysis, qualitative histologic examination, and immunocytochemistry. Morphologic examination of nasal biopsy specimens showed a decrease in focal metaplasia, no change in epithelial thickness, and no sign of atrophy after treatment with mometasone furoate. Immunocytochemical analyses of nasal biopsy specimens obtained before and after treatment revealed a significant decrease in major basic protein–positive eosinophils and tryptase-positive mast cells in the epithelium and lamina propria after treatment. Mometasone furoate appeared to attenuate the inflammatory process by reducing the extent of inflammatory cell infiltration, particularly of eosinophils. This study demonstrated that long-term administration of mometasone furoate is not associated with adverse tissue changes in the nasal mucosa of patients with Perennial Rhinitis. (Otolaryngol Head Neck Surg 1998;118:648-54.)
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Assessment by nasal biopsy of long-term use of mometasone furoate aqueous nasal spray (Nasonex) in the treatment of Perennial Rhinitis.
Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 1998Co-Authors: E Minshall, Valerie J Lund, Omar Ghaffar, L Cameron, H Quinn, R J Davies, A Prior, F. O'brien, Julian Rowe-jones, I S MackayAbstract:Allergic Rhinitis is associated with specific histopathologic changes in the nasal mucosa including squamous metaplasia and local eosinophilia. Previous studies have shown that mometasone furoate aqueous nasal spray is effective and well tolerated in reducing Perennial Rhinitis and seasonal allergic Rhinitis symptoms. We undertook a multicenter, open-label study to evaluate, by nasal biopsy, the tissue changes associated with mometasone furoate use (200 microg/day) during a 12-month treatment period in patients with Perennial Rhinitis. Of the 69 patients enrolled in the study, 52 completed all 12 months of treatment. Nasal biopsy specimens obtained from patients at baseline and after treatment were evaluated in a blinded fashion by computerized image analysis, qualitative histologic examination, and immunocytochemistry. Morphologic examination of nasal biopsy specimens showed a decrease in focal metaplasia, no change in epithelial thickness, and no sign of atrophy after treatment with mometasone furoate. Immunocytochemical analyses of nasal biopsy specimens obtained before and after treatment revealed a significant decrease in major basic protein-positive eosinophils and tryptase-positive mast cells in the epithelium and lamina propria after treatment. Mometasone furoate appeared to attenuate the inflammatory process by reducing the extent of inflammatory cell infiltration, particularly of eosinophils. This study demonstrated that long-term administration of mometasone furoate is not associated with adverse tissue changes in the nasal mucosa of patients with Perennial Rhinitis.
C Andre - One of the best experts on this subject based on the ideXlab platform.
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house dust mite sublingual swallow immunotherapy slit in Perennial Rhinitis a double blind placebo controlled study
Allergy, 2000Co-Authors: S Guez, C Vatrinet, R Fadel, C AndreAbstract:Background: The safety and efficacy of sublingual-swallow immunotherapy (SLIT) in Rhinitis caused by house-dust mite were evaluated in a double-blind, placebo-controlled study including 75 patients for 24 months. Methods: Patients received either placebo or SLIT with a standardized Dermatophagoides pteronyssinus (D.pt.) –D. farinae (D.f.) 50/50 extract. The mean cumulative dose was 90 000 IR, equivalent to 2.2 mg of Der p 1 and 1.7 mg of Der f I. Symptom and medication scores were assessed throughout the study. Exposure to house-dust mite, skin sensitivity, and serum specific IgE and IgG4 were assessed before starting treatment and after 12 and 24 months. Results: Seventy-two patients (36 active–36 placebo) were eligible for intent-to-treat analysis. Thirty-six patients dropped out of the study. The number of patients who dropped out due to lack of efficacy was eight out of 37 (21.6%) in the active treatment group compared to 15 out of 38 (39.5%) in the placebo group (chi-square=2.81, P=0.09). Total symptom and medication scores decreased significantly after 12 and 24 months (P<0.05) of treatment in both groups, but no significant difference was observed between the active and placebo groups. After 24 months, the number of patients with high levels of indoor allergenic load decreased significantly in both groups compared to baseline data (P=0.01). Specific IgE (D.pt. and D.f.) increased significantly in the active treatment group after 12 and 24 months, while no change was observed in the placebo group. Specific IgG4 levels were not significantly modified in either group. Two patients in each group reported mild adverse effects. No severe adverse effects were reported. Conclusions: We conclude that SLIT in Rhinitis caused by house-dust mite was safe, but there was a lack of consistent clinical benefit compared to placebo, probably due to the impact of the allergen avoidance measures that lowered the allergen burden.
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sublingual swallow immunotherapy slit with a standardized five grass pollen extract drops and sublingual tablets versus placebo in seasonal Rhinitis
Allergy, 1999Co-Authors: A Pradalier, D Basset, A Claudel, P Couturier, F Wessel, S Galvain, C AndreAbstract:Background: Recent studies have demonstrated the efficacy of sublingual-swallow immunotherapy (SLIT) in seasonal and Perennial Rhinitis. Sublingual administration of solutions is not convenient for all patients. The aim of the study was to evaluate the efficacy and safety of immunotherapy administered sublingually, initially as drops, and then as tablets during maintenance therapy. Methods: A total of 126 patients with grass-pollen seasonal Rhinitis were included in this double-blind, randomized, placebo-controlled trial. During the progression of doses phase, the five-grass extract was given as sublingual drops from 1 to 100 IR/ml. Once the 100 IR dose was reached, the drops were replaced by a single 100-IR sublingual tablet per day. Results: Throughout the grass-pollen season, patients in the active treatment group had significantly lower (P<0.05) total conjunctivitis and ocular redness scores. Rhinitis symptoms were not significantly different between the two groups. Patients given the active treatment were significantly (P<0.02) less likely to have asthma symptoms. The global medication score showed no significant difference between the two groups. A highly significant difference in favor of the active treatment group was seen in inhaled salbutamol use (P<0.01). Conclusions: Clinical benefits achieved during the present study included significant improvements in conjunctivitis symptoms and prevention of asthma symptoms. The overall safety profile of the active treatment (drops or tablets) was good.
Chester C Wood - One of the best experts on this subject based on the ideXlab platform.
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comparison of ipratropium bromide 0 03 with beclomethasone dipropionate in the treatment of Perennial Rhinitis in children
Annals of Allergy Asthma & Immunology, 1999Co-Authors: Henry Milgrom, John W Georgitis, Robert Biondi, Eli O Meltzer, Zev Munk, Kristin Drda, Chester C WoodAbstract:Objective To compare the safety and efficacy of ipratropium bromide 0.03% (IB) with beclomethasone dipropionate 0.042% (BDP) in the treatment of Perennial Rhinitis in children. Methods Thirty-three children with nonallergic Perennial Rhinitis (NAPR) and 113 with allergic Perennial Rhinitis (APR) were randomly assigned to either IB or BDP for 6 months in a single-blind, multicenter protocol in which the physician was blinded to treatment. At each visit, patients and physicians rated symptom control of rhinorrhea, nasal congestion, and sneezing. Patients also completed quality of life questionnaires at baseline and after 6 months of therapy. Results Both treatments showed a significant improvement in control of rhinorrhea, congestion, and sneezing compared with baseline over the 6 months of treatment ( P P P Conclusions Ipratropium bromide was safe and effective in controlling rhinorrhea and diminishing the interference by rhinorrhea in school attendance, concentration on school work, and sleep. Ipratropium bromide was as effective as BDP in the control of rhinorrhea and showed a relatively good effect on congestion. Patient and physician assessment favored BDP in the control of sneezing.
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ipratropium bromide nasal spray 0 03 provides additional relief from rhinorrhea when combined with terfenadine in Perennial Rhinitis patients a randomized double blind active controlled trial
American Journal of Rhinology, 1998Co-Authors: Albert F Finn, Donald W Aaronson, Kristin Drda, Phillip Korenblat, William R Lumry, Guy A Settipane, Sheldon L Spector, Thomas Woehler, Chester C WoodAbstract:Medical treatment of Perennial Rhinitis is aimed at providing symptomatic relief of individual symptoms. Multiple agents are administered when no single agent provides complete relief. Studies assessing the benefit/risk of combined therapy are important, especially for newly available agents such as ipratropium bromide nasal spray, a topical anticholinergic agent approved for the treatment of rhinorrhea in allergic and nonallergic Perennial Rhinitis. The objective was to determine whether the combined use of ipratropium bromide nasal spray 0.03% (42 mcg per nostril) administered three times daily with a nonsedating antihistamine (terfenadine, 60 mg administered twice daily) is safe and provides greater clinical benefit than use of the placebo nasal spray plus terfenadine. Our method was a multicenter, 6-week, double-blind, randomized, active-controlled, crossover trial of 205 patients with Perennial Rhinitis (114 allergic and 91 nonallergic), 18 to 75 years of age, who had clinically significant rhinorrhea. After a 1-week run-in period, patients were treated for 2 weeks with one of the two treatment regimens, followed by a 1-week washout period, and then were treated for another 2 weeks with the other treatment regimen. Daily diary symptoms scores of rhinorrhea, congestion, and sneezing were obtained, as well as biweekly patient and physician global assessments of treatment effectiveness of each of the nasal symptoms. Ipratropium bromide nasal spray plus terfenadine was more effective than vehicle plus terfenadine in reducing the average severity (38% versus 28%) and duration (46% versus 30%) of rhinorrhea during the 2 weeks of treatment from baseline (p < 0.05). The advantage of ipratropium bromide nasal spray plus terfenadine was evident by the second day of treatment and continued throughout the 2-week treatment period. Of patients who responded more to one treatment than another, 69% responded to ipratropium bromide nasal spray plus terfenadine, compared to 31% to vehicle plus terfenadine (p < 0.05). Both physicians and patients rated control of rhinorrhea and sneezing by ipratropium bromide nasal spray plus terfenadine as superior to vehicle plus terfenadine (p < 0.05). The symptom of congestion was controlled equally well by both treatments. Combined active therapy was well tolerated with no increase in adverse events over that seen previously with ipratropium bromide nasal spray alone. The combination of ipratropium bromide nasal spray with terfenadine is more effective than vehicle plus terfenadine for the treatment of rhinorrhea, and does not result in a potentiation of adverse drug reactions.
Keith B Nolop - One of the best experts on this subject based on the ideXlab platform.
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onset of action of mometasone furoate nasal spray nasonex in seasonal allergic Rhinitis
Allergy, 1999Co-Authors: R B Berkowitz, David I Bernstein, C Laforce, Andrew Pedinoff, A Rooklin, C V Damaraju, B Mesarinawicki, Keith B NolopAbstract:Background:Mometasone furoate nasal spray (MFNS, NASONEX®), is a new synthetic corticosteroid with considerable efficacy in the treatment of seasonal and Perennial Rhinitis and less than 0.1% systemic absorption. This study was designed to evaluate the time of onset of action of MFNS. The subjects were evaluated over the course of 2 weeks during the spring allergy season. Methods:The effects of MFNS 200 μg given once daily for 2 weeks were evaluated in a randomized, multicenter, double-blind, placebo-controlled study in 201 patients with seasonal allergic Rhinitis. Clinically significant onset of action was assessed prospectively by special patient diary cards kept during the first 3 days of treatment. Results:By 12 h after initial dosage (the earliest evaluation), 28% of patients in the MFNS group experienced clinically significant relief, compared with 13% of those given placebo (P=0.01). Median time to at least moderate symptom relief in patients who received MFNS was 35.9 h, compared with more than 72 h in patients given placebo (P<0.01). By 72 h, 64% of the patients receiving MFNS experienced at least moderate relief, compared with 40% of those treated with placebo (P<0.01). Both patient and physician ratings of symptom severity, response to treatment, and overall condition of Rhinitis indicated significant (P<0.01) superiority of MFNS over placebo. MFNS was well tolerated, with adverse events comparable to placebo. Conclusions:MFNS provided rapid onset of clinically significant symptom relief in patients with seasonal allergic Rhinitis.
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comparison of once daily mometasone furoate nasonex and fluticasone propionate aqueous nasal sprays for the treatment of Perennial Rhinitis
Annals of Allergy Asthma & Immunology, 1997Co-Authors: Michael Mandl, Keith B Nolop, Barry N. LutskyAbstract:Background Mometasone furoate (Nasonex), in a new once daily aqueous nasal spray formulation, has been shown to be as effective and well tolerated as twice daily beclomethasone dipropionate aqueous nasal spray in treating symptoms of seasonal allergic Rhinitis and Perennial Rhinitis. Objective To compare the effectiveness and tolerability of mometasone furoate to placebo and to fluticasone propionate aqueous nasal spray, all treatments administered once daily, in patients with Perennial Rhinitis. Methods This was a 3-month, randomized, double-blind, double dummy, parallel group study in 550 patients, aged 12 to 77 years, at 25 centers in Canada, Latin America, and Europe. Patients allergic to at least one Perennial allergen, with confirmed allergy history, skin test positivity, and moderate to severe symptomatology, were eligible to receive one of the following treatments, once daily in the morning: mometasone furoate 200 micrograms, fluticasone propionate 200 micrograms, or placebo. The primary efficacy variable was the change from baseline in total am plus pm diary nasal symptom score over the first 15 days of treatment. Results Four hundred fifty-nine patients were valid for efficacy. For the primary efficacy variable, mometasone furoate was significantly ( P .01) more effective than placebo and was not statistically different from fluticasone propionate (percent reductions from baseline were 37, 39, and 22 for mometasone furoate, fluticasone propionate, and placebo, respectively). Generally, similar trends were seen for physician-evaluated total nasal symptoms, and patient-rated and physician-rated overall condition and response to therapy. Overall, mometasone furoate was at least as effective as fluticasone propionate at equivalent doses. There was no evidence of tachyphylaxis. All treatments were well tolerated. Conclusion Mometasone furoate and fluticasone propionate adequately controlled symptoms of Perennial Rhinitis and were well tolerated.