Fluticasone Nasal Spray Research Articles

Combination therapy with azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in the treatment of patients with seasonal allergic rhinitis

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. 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. 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. All 3 groups had statistically significant (P < .001) improvements from their baseline TNSS after 2 weeks of treatment. The TNSS improved 27.1% with fluticasone nasal spray, 24.8% with azelastine nasal spray, and 37.9% with the 2 agents in combination (P < .05 vs either agent alone). All 3 treatments were well tolerated. 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.

Azelastine Nasal Spray and Fluticasone Nasal Spray in the Treatment of Geriatric Patients with Rhinitis

Treatment of Geriatric Patients with Rhinitis V. B. Behncke1, G. Alemar2, D. A. Kaufman1, F. J. Eidelman1; 1Allergy and Immunology, Cleveland Clinic Florida, Weston, FL, 2Otorhinolaryngology, Cleveland Clinic Florida, Weston, FL. RATIONALE: The prevalence and differential diagnosis of rhinitis changes over time, with nonallergic rhinitis increasingly prevalent in the fifth decade of life. This study was conducted to evaluate the effect of an antihistamine nasal spray (azelastine hydrochloride) and a corticosteroid nasal spray (fluticasone propionate) in treating geriatric patients with allergic or nonallergic rhinitis. METHODS: This was an open-label trial in 18 patients 65 years and older with a history of moderate-to-severe rhinitis. Eligible patients were randomized to treatment with either azelastine nasal spray 2 sprays per nostril bid (1.1 mg) or fluticasone 2 sprays per nostril qd (200 mcg) for a 6-week study period. The primary outcome variable was quality of life as assessed by the Rhinitis Quality of Life Questionnaire (RQLQ). Patients completed the RQLQ at baseline and at week 3 and week 6. Patients also recorded symptoms and side effects each day in a diary. RESULTS: Three patients had positive allergen skin tests and 15 had negative skin tests. Both treatments led to significant improvement from baseline in the RQLQ score after 3 and 6 weeks of treatment and there were no significant differences between treatment groups. Both treatments improved symptom scores compared to baseline, with statistically significant improvement at week 2 through 6 in the fluticasone group and at week 4 in the azelastine group. There were no significant differences between azelastine and fluticasone at week 6. CONCLUSIONS: Azelastine nasal spray and fluticasone nasal spray improved RQLQ scores and rhinitis symptom scores in geriatric patients with either allergic or nonallergic rhinitis.

Apical ballooning syndrome

After a family argument, an 83-year-old woman experienced chest pain, a "racing heart," and a choking sensation and was brought to the emergency department. The chest pain lasted 10 to 15 minutes; was sharp, substernal, and nonradiating; and was associated with dyspnea and a bout of emesis. A sublingual nitroglycerin tablet partially alleviated the pain, but the patient felt syncopal. Her symptoms persisted despite the administration of supplemental oxygen and a second sublingual nitroglycerin tablet. The patient had a history of gastroesophageal reflux disease, allergic rhinitis, and osteoarthritis. Her oral medications included esomeprazole (40 mg/d), aspirin (81 mg/d), and fluticasone nasal spray. She had discontinued valdecoxib 3 weeks earlier.

Evaluation of fluticasone (flixonase) nasal spray versus beclomethasone (beconase) nasal spray in the treatment of allergic rhinitis.

Although response to intranasal steroid therapy has been reported in patients with allergic rhinitis, efficacy of some nasal steroids is noteworthy.This study was undertaken to evaluate the efficacy of a two-week course of Fluticasone (Flixonase) nasal spray vs. Beclomethasone (beconase) nasal spray in patients with symptoms of allergic rhinitis referred to our clinic. This study reviewed sixty randomized studies with symptoms of allergic rhinitis which supported common aeroallergens with skin prick test. Patients received a total daily dose of nasal spray of Fluticasone (Flixonase) 100 mcg bid (N=30) compared with patients with allergic rhinitis who received a total daily dose of Beclomethasone (Beconase) 50mcg 2 puffs bid (N=30). Patients were visited before and after therapy, and efficacy of Flixonase and Beconase was evaluated by the change in nasal symptoms including: nasal discharge, nasal obstruction, nasal itching, and sneezing. After two weeks of treatment nasal symptoms of blockage, discharge, sneezing and itching were significantly better in the group treated with Fluticasone nasal spray (65%, 82%, 67%, 79% respectively (p<0.001) but after treatment with beconase nasal spray lower benefits in the nasal symptoms includes: 50%, 71%, 51%, 57% respectively. After two weeks of treatment no deleterious changes consequent to therapy were observed in nasal symptoms. 100 mcg bid Flixonase (Fluticasone) intranasal spray is more effective than 50 mcg 2 puffs bid Beconase (Beclomethasone) intranasal spray. Like asthma, allergic rhinitis is an inflammatory disease and should be managed with anti-inflammatory medication.

The Effect of Topical Fluticasone on Nasal Nitric Oxide Levels in a Patient with Allergic Rhinitis

Nitric oxide (NO) in exhaled breath is produced primarily by the upper respiratory airway mucosa. The nasal output of this gas is increased in patients with allergic rhinitis. We performed a study on a 41-year-old nonsmoking male volunteer with allergic rhinitis to investigate the effect of fluticasone nasal spray on nasal NO output (VNO). A total of 28 nasal NO measurements from both nostrils were taken during the 2-month period of June and July 2002. During the second half of the study period (treatment phase), the patient took fluticasone in doses of 100 micrograms per nostril once a day. During the treatment phase, nasal NO measurements were taken 10 days after the initiation of treatment. In addition, we also recorded the patient's nasal symptom scores and the grass pollen counts in the greater Pittsburgh area. The patient's mean VNO was 989.9 nl/min prior to treatment and 787.7 nl/min following treatment--a statistically significant 20.4% decrease (p < 0.01). The findings of our study support the observation that topical nasal steroid treatment decreases NO production in sinonasal mucosa.

Fluticasone Nasal Spray and the Combination of Loratadine and Montelukast in Seasonal Allergic Rhinitis

To compare the effectiveness of an intranasal steroid treatment with that of the combination of a histamine1 receptor antagonist and a leukotriene D receptor antagonist in the treatment of seasonal allergic rhinitis. A 2-week, parallel, randomized, double-blind, double-dummy study with rolling enrollment. Tertiary care medical center. Subjects A total of 63 adults with a 2-year history of ragweed sensitivity in the Chicago, Ill, area and a positive skin-prick reaction to ragweed pollen. Intervention Subjects were randomized to receive either 100 micro g of fluticasone propionate aqueous nasal spray in each nostril or 10 mg of loratadine and 10 mg of montelukast sodium by mouth once daily in the evening for 2 weeks. At visits 1 and 2, subjects completed a quality-of-life questionnaire and underwent nasal lavage to determine total eosinophil count and eosinophil cationic protein (ECP) measurements. Daily symptom diaries were kept for 2 weeks. Questionnaire answers, daily nasal symptom scores, eosinophil counts, and ECP levels. Median total nasal symptom scores were lower in the fluticasone group (4.5 vs 6), but the difference was not statistically significant. The questionnaire answers showed dramatic improvement in overall and individual domains for both groups (P<.01 vs visit 1) with significantly greater reduction in nasal symptoms in the fluticasone group (P<.05). Eosinophil counts and ECP levels were significantly reduced in the fluticasone group. Both treatments provided clinically meaningful responses, but the overall results favored fluticasone propionate.

Efficacy of fluticasone nasal spray for pediatric obstructive sleep apnea

Objective: We tested the hypothesis that a 6-week course of a nasal glucocorticoid spray would decrease the severity of obstructive sleep apnea in children with adenotonsillar hypertrophy. Study design: We conducted a randomized, triple-blind, placebocontrolled, parallel-group trial of nasal fluticasone propionate versus placebo in 25 children aged 1 to 10 years with obstructive sleep apnea proven on polysomnography. The primary outcome was the change from baseline in the frequency of mixed and obstructive apneas and hypopneas. Results: Thirteen children received fluticasone, and 12 received placebo. The mixed/obstructive apnea/hypopnea index decreased from 10.7 ± 2.6 (SE) to 5.8 ± 2.2 in the fluticasone group but increased from 10.9 ± 2.3 to 13.1 ± 3.6 in the placebo group, P =.04. The mixed/obstructive apnea/hypopnea index decreased in 12 of 13 subjects treated with fluticasone versus 6 of 12 treated with placebo, P =.03. The frequencies of hemoglobin desaturation and respiratory movement/arousals also decreased more in the fluticasone group. Changes from baseline in tonsillar size, adenoidal size, and symptom score were not significantly different between groups. Conclusion: Nasal fluticasone decreased the frequency of mixed and obstructive apneas and hypopneas, suggesting that topical corticosteroids may be helpful in ameliorating pediatric obstructive sleep apnea. (J Pediatr 2001;138:838-44)

Pulmonary vasculitis presenting as atypical asthma

CASE REPORT A 9-year-old female was referred to our clinics in January 1998 because of multisystem complaints. The patient had a 2-year history of cough, episodes of chest pain, and tightness upon increasing activity. The patient had minimal response to 2-agonists and was noted to improve upon treatment with oral glucocorticosteroids. She was diagnosed with atypical asthma and was treated with inhaled glucocorticosteroids and 2-agonists. Concomitant with chest symptoms, the patient experienced frequent arthralgias, fatigue, generalized lymphadenopathy, hypertension, transient ischemic attacks, Raynaud’s phenomenon, growth failure, abdominal pain, headaches, and frequent infections characterized as recurrent otitis media and sinusitis. Her medications included beclomethasone inhaler double strength 2 puffs bid, albuterol inhaler every 4 to 6 hours as needed, fluticasone nasal spray 1 spray qd, loratidine 5 mg qd, sucralfate 1 g tid, nifidipine 30 mg qd, baby aspirin 81 mg qd, ibuprofen every 6 to 8 hours as needed and growth hormone injection qd. The patient was admitted to the hospital for further evaluation and treatment. On physical examination, the patient weighed 25.6 kg (5th percentile) and was 126 cm in height ( 5th percentile). Pertinent findings included mobile and tender cervical, axillary, and inguinal lymphadenopathy; clear breath sounds; mild epigastric tenderness; and hepatosplenomegaly. Capillary nail beds were abnormal in that they exhibited telangiectasia and vascular dropout. The skin was dry with a fixed salmoncolored macular rash on the upper chest and neck. The rest of the physical examination was unremarkable.

Cytokine immunoreactivity in seasonal rhinitis: regulation by a topical corticosteroid.

Seasonal allergic rhinitis is characterized by the development of nasal mucosal inflammation in response to natural allergen exposure, and is prevented by the administration of topical corticosteroids. Interleukin-4 (IL-4), IL-5, and IL-6 may have important roles in this process, and in vitro the gene transcription for each of these cytokines is inhibited by corticosteroids. In this study we have therefore investigated the effect of seasonal allergen exposure on the expression of immunoreactivity for IL-4, IL-5, and IL-6 in nasal mucosal biopsies, and the effect of regular prophylactic treatment with the topical corticosteroid, fluticasone propionate. Following a nasal mucosal biopsy out of season, patients were randomized double-blind to receive 6 wk of treatment during the pollen season with either topical fluticasone nasal spray (200 micrograms daily) or matching placebo. Each subject underwent a repeat nasal biopsy at the end of the 6-wk treatment period. Seasonal increases in epithelial eosinophils (p = 0.046), submucosal eosinophils (p = 0.001), and epithelial mast cells (p = 0.055) occurred in the placebo--but not the fluticasone-treated patients. Submucosal mast cell numbers did not change in either group. Immunoreactivity for IL-4 and IL-6 was localized predominantly to mast cells while IL-5 was found in both mast cells and eosinophils. Numbers of IL-4+ cells in the nasal submucosa were significantly suppressed by treatment with fluticasone (p = 0.0003 for monoclonal antibody [mAb] 3H4, p = 0.041 for mAb 4D9). In contrast, fluticasone treatment failed to influence the number of IL-5 and IL-6 immunoreactive cells.(ABSTRACT TRUNCATED AT 250 WORDS)

Assessment of quality of life in adolescents with allergic rhinoconjunctivitis: Development and testing of a questionnaire for clinical trials

Background: The objectives of the study were to evaluate impairment in quality of life in 12- to 17-year-old patients with seasonal allergic rhinoconjunctivitis and to develop and test a questionnaire suitable for evaluating change in quality of life during clinical trials. Methods: Patients were asked to identify physical and emotional impairments associated with allergic rhinoconjunctivitis. The resultant questionnaire was tested for responsiveness and validity in a clinical trial in which fluticasone nasal spray and loratadine were compared for treatment of ragweed pollen—induced rhinoconjunctivitis. Eighty-three patients, 12 to 17 years of age, with grass- or ragweed-induced hayfever participated in the instrument development phase. They were recruited for the study from an allergy clinic and local schools and recreational organizations. Two hundred forty patients with ragweed hayfever participated in the clinical trial and provided quality of life data. Results: The survey showed that in addition to local symptoms, patients experienced impairment of quality of life because of systemic symptoms, activity limitations, and emotional and practical problems. The resultant questionnaire has 25 items in six domains. In the clinical trial responsiveness was demonstrated by the questionnaire's ability to detect change over time and differences between treatments. Construct validity was demonstrated by moderate to strong relationships between changes in diary symptom scores and quality of life. Conclusions: The items identified by 12- to 17-year-old patients were not identical to those previously identified by adults. This suggests that impairment of quality of life may not be the same in the two groups and that it is appropriate to have a questionnaire specifically designed for adolescent rhinoconjunctivitis clinical trials.