David F. Graft

Dose Ranging Study of Mometasone Furoate (Nasonex) in Seasonal Allergic Rhinitis

BACKGROUND Topical nasal corticosteroids are rapidly gaining acceptance as first-line therapy for seasonal allergic rhinitis, but there is a desire for effective corticosteroids with an improved safety profile over existing products. OBJECTIVE A multicenter, double-blind dose ranging study was conducted to compare the activity and tolerance of four doses of mometasone furoate nasal spray (tradename Nasonex) and placebo in adult patients with seasonal allergic rhinitis. METHODS Four hundred eighty patients with seasonal allergic rhinitis were enrolled and randomized to receive mometasone furoate nasal spray 50 micrograms (n = 96), 100 micrograms (n = 95), 200 micrograms (n = 98) or 800 micrograms (n = 95), or placebo vehicle (n = 95) once daily for 28 days. RESULTS All of the doses of mometasone furoate nasal spray showed activity in reducing the severity of rhinitis. The 200-microgram dose reduced total nasal symptom scores and total symptom scores throughout the study (P < .05 versus placebo vehicle). The 50-microgram dose and the 100-microgram dose showed less consistent activity at early timepoints (days 3 and 7), while the 800 microgram dose did not provide significant additional benefits over the 200-microgram dose. All dose levels were well tolerated CONCLUSION The results of this trial indicate that 200 micrograms once daily is the optimum dose of mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis.

Mometasone furoate: efficacy and safety in moderate asthma compared with beclomethasone dipropionate

BACKGROUND Mometasone furoate (MF) is a new inhaled glucocorticoid administered by dry powder inhaler (DPI). OBJECTIVE MF-DPI was evaluated for safety and efficacy and compared with placebo DPI and beclomethasone dipropionate (BDP) administered by metered dose inhaler (MDI) in the treatment of patients with moderate persistent asthma. METHODS Eligible patients (n = 227), 13 to 75 years of age, maintained on inhaled glucocorticoids before entering the trial, were randomized to receive: MF-DPI, 100 microg, twice daily, MF-DPI, 200 microg, twice daily, BDP MDI, 168 microg, twice daily, or placebo in a 12-week, multicenter, double-blind study. RESULTS At endpoint, FEV1 (primary efficacy variable) significantly improved for all three active treatments compared with placebo (P < .01, all comparisons). The response to MF-DPI, 200 microg, twice daily treatment was approximately twice as large as the response to MF-DPI, 100 microg, twice daily or BDP MDI treatment, although the differences between these groups did not reach statistical significance. Secondary efficacy variables including PEFR, asthma symptoms, nocturnal awakenings, and albuterol use showed similar trends. The MF-DPI, 100 microg, twice daily and BDP MDI, 168 microg, twice daily treatment groups produced comparable results for all efficacy variables. CONCLUSIONS MF-DPI, 100 microg and 200 microg, twice daily were well-tolerated and significantly improved lung function and symptom control in the treatment of patients with moderate persistent asthma. In this study, MF-DPI, 200 microg, twice daily seemed to be the most effective dosage.

Comparison of triamcinolone acetonide nasal inhaler with astemizole in the treatment of ragweed-induced allergic rhinitis*

BACKGROUND Few clinical trials have directly compared the efficacy of antihistamines with topical nasal corticosteroids. OBJECTIVE The study was performed to compare the efficacy and safety of triamcinolone acetonide nasal spray at a dose of 110 micro g in each nostril once daily with 10 mg of oral astemizole once daily for the treatment of seasonal allergic rhinitis. METHODS A multicenter, double-blind, parallel-group study was conducted in 239 patients who were randomized to receive either triamcinolone acetonide or astemizole. A 5-day, drug-free, lead-in period was followed by 4 weeks of double-blind treatment. One hundred four patients treated with triamcinolone acetonide and 105 patients treated with astemizole could be evaluated. RESULTS Overall, triamcinolone acetonide was more effective than astemizole in reducing total nasal symptoms, nasal stuffiness, nasal itching, and sneezing (p </= 0.01). Triamcinolone acetonide was superior to astemizole at weeks 1, 2, and 3 in reduction of the total nasal symptom score (p </= 0.0401) and in reduction of nasal stuffiness (p </= 0.05). Improvements in individual nasal symptoms (itching, postnasal drip, runny nose, and sneezing) were greater for triamcinolone acetonide at week 2 (p </= 0.01). Ocular symptoms improved from baseline in both groups. When pollen counts were correlated to mean nasal rhinitis scores, the triamcinolone acetonide group showed continued improvement from week 1 to week 2 in nasal symptoms when pollen counts were at their highest. During the same period, patients treated with astemizole failed to show improvement from week 1 to week 2. This study demonstrated that once daily administration of triamcinolone acetonide was more effective than astemizole for controlling nasal symptoms of seasonal allergic rhinitis, especially during the peak pollination period.

Stinging insect hypersensitivity: A practice parameter update 2016

Reprints: David B. K. Golden, MD, Department o dbkgolden@gmail.com. Disclaimer: The American Academy of Allergy, A accepted responsibility for establishing “Stinging I time. The medical environment is a changing envi of many participants, no single individual, includ practice parameters. Any request for information a the AAAAI or the ACAAI. These parameters are no Disclosures: The following is a summary of inter family member interests). Completed Conflict of In its website. Dr Golden has served on the speaker’s witness for & Trifrolis, PC, and is a section editor UptoDate. The other Work Group members have n conflict with development of a completely unbiase conflicts from influencing the final document in discussions concerning topics related to the poten remove potential bias. In addition, the entire docu sent for review both by invited reviewers and by Chief Editor: David B. K. Golden, MD Practice Parameter Work Group: David B.K. Gold Allergy, Asthma & Immunology Center of Alaska, Allergy Clinic, San Antonio, Texas; David Graft, MD Minneapolis, Minnesota; Michael Tankersley, MD, of Nebraska College of Medicine, and Allergy, Asth University Medical Center, Palo Alto, California. Membersof theJointTaskForceonPracticeParame of Cincinnati CollegeofMedicine,Cincinnati, Ohio; Joa Department of Pediatrics, University ofMissouri-Kan City,Missouri;MatthewGreenhawt,MD,AllergySect of InternalMedicine, University of Texas Southweste Institute, ClevelandClinic, Cleveland,Ohio; RichardN Internal Medicine, New JerseyMedical School, Pulmo Mercy Hospital, and Department of Pediatrics, Unive AffiliatedHospitals, Center for Allergy, Asthma, & Imm Medical College, Hershey, Pennsylvania; and DanaW InvitedReviews(inalphabeticalorder):WesleyBurk Columbia, Maryland; AndrewMurphy, MD, Downin All published practice parameters are available at htt The Joint Task Force hasmade a concerted effort to ac appropriate recognition of such contributions is mad

Safety of fexofenadine in children treated for seasonal allergic rhinitis

BACKGROUND The incidence of allergic rhinitis in children is increasing. OBJECTIVE To evaluate the safety of fexofenadine HCI in children ages 6 through 11 years for treatment of seasonal allergic rhinitis. METHODS Two large, double-blind, randomized, placebo-controlled, parallel studies with identical protocols included patients with a positive skin test to fall allergen(s) and allergic rhinitis symptoms. Patients were randomized to receive fexofenadine 15, 30, or 60 mg or placebo twice daily for 2 weeks after a 1-week placebo lead-in. Safety was evaluated through adverse event reporting, electrocardiograms, and pre- and posttreatment laboratory panels and physical examinations. RESULTS A total of 875 patients from both studies were eligible for safety analyses. Ten patients (5 on placebo, 5 on fexofenadine) discontinued because of an adverse event; no event that resulted in discontinuation was judged to be caused by study medication. Incidence of adverse events was similar in active and placebo groups, and did not increase with increasing fexofenadine dose: 36.2% (83 of 229) in the placebo group versus 35.3% (79 of 224), 36.8% (77 of 209), and 34.7% (74 of 213) in the 15, 30, and 60 mg twice-daily fexofenadine groups, respectively. Headache was the most commonly reported adverse event (6.6%, 8.0%, 7.2%, and 9.4% in the placebo, 15, 30, 60 mg twice-daily fexofenadine groups, respectively). Clinical, vital sign, electrocardiogram, and laboratory measures were similar in active and placebo groups. There was no statistically significant mean change from baseline in any electrocardiogram parameter after fexofenadine treatment. CONCLUSIONS Fexofenadine, 15, 30, and 60 mg twice daily, was safe and well tolerated in this large pediatric patient population.

Practice ParameterStinging insect hypersensitivity: A practice parameter update 2016

Reprints: David B. K. Golden, MD, Department o dbkgolden@gmail.com. Disclaimer: The American Academy of Allergy, A accepted responsibility for establishing “Stinging I time. The medical environment is a changing envi of many participants, no single individual, includ practice parameters. Any request for information a the AAAAI or the ACAAI. These parameters are no Disclosures: The following is a summary of inter family member interests). Completed Conflict of In its website. Dr Golden has served on the speaker’s witness for & Trifrolis, PC, and is a section editor UptoDate. The other Work Group members have n conflict with development of a completely unbiase conflicts from influencing the final document in discussions concerning topics related to the poten remove potential bias. In addition, the entire docu sent for review both by invited reviewers and by Chief Editor: David B. K. Golden, MD Practice Parameter Work Group: David B.K. Gold Allergy, Asthma & Immunology Center of Alaska, Allergy Clinic, San Antonio, Texas; David Graft, MD Minneapolis, Minnesota; Michael Tankersley, MD, of Nebraska College of Medicine, and Allergy, Asth University Medical Center, Palo Alto, California. Membersof theJointTaskForceonPracticeParame of Cincinnati CollegeofMedicine,Cincinnati, Ohio; Joa Department of Pediatrics, University ofMissouri-Kan City,Missouri;MatthewGreenhawt,MD,AllergySect of InternalMedicine, University of Texas Southweste Institute, ClevelandClinic, Cleveland,Ohio; RichardN Internal Medicine, New JerseyMedical School, Pulmo Mercy Hospital, and Department of Pediatrics, Unive AffiliatedHospitals, Center for Allergy, Asthma, & Imm Medical College, Hershey, Pennsylvania; and DanaW InvitedReviews(inalphabeticalorder):WesleyBurk Columbia, Maryland; AndrewMurphy, MD, Downin All published practice parameters are available at htt The Joint Task Force hasmade a concerted effort to ac appropriate recognition of such contributions is mad

When to start, when to stop, and what to measure in venom immunotherapy: Issues in allergy Grand seminar, AAAI Annual Meeting 1990

Dr. Reisman: It is time to carefully consider some of the concepts that evolved some 10 years ago when venoms first became available. I will discuss the proper concentration of venom for making a diagnosis and some details regarding VIT, including the choice of which venom to use, the appropriate dose of venom for VIT, and the maintenance interval between injections. For VST, a positive reaction has been defined as a 1 + or greater reaction at a concentration of 1 pglml or less. That recommendation was based on the original study done at Johns Hopkins, which compared 30 allergic patients with 30 nonallergic patients and

A controlled trial of twice daily triamcinolone oral inhaler in patients with mild-to-moderate asthma

BACKGROUND National and international guidelines recommend inhaled anti-inflammatory medications for patients with all but the mildest forms of asthma. Patients may also be more compliant with twice daily dosing. OBJECTIVE To evaluate the efficacy and safety of triamcinolone acetonide (triamcinolone acetonide), 400 microg bid, in mild-to-moderate asthma patients. METHODS A multicenter, randomized, double-blind, placebo-controlled study with a 7- to 21-day baseline and 6-week treatment period. Adult mild-to-moderate asthma patients poorly controlled by beta2-agonists alone were randomized to receive placebo (48) or triamcinolone acetonide (53). Patients recorded daytime and nighttime asthma symptoms, albuterol use, and morning and evening peak expiratory flow (PEF) rates on diary cards. Clinic spirometry measures included FEV1, FEF25-75%, FVC, FEV1/FVC, and PEF. RESULTS Triamcinolone acetonide treatment resulted in improvement from baseline of 17% for FEV1 (P < .0001); 44% for albuterol use (P = .0009); 9% for FVC (P = .0185); 19% for PEF (P = .0011); 42% for FEF25-75% (P < .0001); 8% for FEV1/FVC (P = .0016); 36% for daytime, 39% for nighttime, and 38% for total asthma symptoms (P < or = .0001); and 12% for morning, and 10% for evening PEF (P < or = .001). These changes were highly significant when compared with placebo (P < or = .0185). Significant improvement for all variables was demonstrated within 1 to 2 weeks of active treatment, and maintained for most variables over the 6-week treatment phase. Both treatments were well tolerated. Respiratory adverse events occurred more frequently with placebo; pharyngitis was reported more frequently with triamcinolone acetonide. CONCLUSIONS Triamcinolone acetonide, administered twice daily, can effectively and safely treat patients with milder forms of asthma. In these patients, triamcinolone acetonide improves asthma symptoms and decreases the need for as-needed beta2-agonists.