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Biomedical subjects

Martha V White

Publications and source records attributed to Martha V White.

4 recordsLinked to original sources

Relative potency of fexofenadine HCl 180 mg, loratadine 10 mg, and placebo using a skin test model of wheal-and-flare suppression.

BACKGROUND: H1-receptor antagonists differ in their ability to produce peripheral H1-blockade. Suppression of histamine-induced flares and wheals is a useful objective test for measuring these differences. OBJECTIVE: To evaluate the relative potency of fexofenadine HCI 180 mg, loratadine 10 mg, and placebo (PBO) in suppressing histamine-induced flares and wheals and compare the onset, duration, and maximum suppression of histamine achieved with each agent. METHODS: Thirty healthy volunteers were enrolled in this randomized, double-blind, single-dose, crossover study. Flares and wheals induced by skin-prick testing with histamine 1.8 mg/mL were measured before treatment, every 20 minutes during the first hour after dosing, and thereafter hourly between 2 and 12 hours and between 23 and 25 hours postdose. RESULTS: Fexofenadine was significantly more effective than loratadine in suppressing the histamine-induced flare response at hours 2 through 7 and 10 through 12 and produced greater flare suppression than did PBO at hours 2 through 25. Onset of flare suppression occurred 2 hours after dosing with fexofenadine and 4 hours after dosing with loratadine. Likewise, fexofenadine was superior to loratadine in suppressing the wheal response from hours 1 through 12 and was more effective than PBO at hours 1 through 12, 24, and 25. Throughout the 25-hour measurement interval, the magnitude of difference in both wheal and flare suppression consistently favored fexofenadine over loratadine. CONCLUSIONS: In a skin test model of wheal-and-flare suppression, fexofenadine showed rapid distribution into the skin compartment with faster onset of action and greater potency vs loratadine.

Adolescent↗

Efficacy of azelastine nasal spray in patients with an unsatisfactory response to loratadine.

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 (<25% to 33% improvement taking loratadine) were randomized to treatment with azelastine nasal spray 2 sprays per nostril, twice daily, azelastine nasal spray 2 sprays per nostril, twice daily, plus loratadine 10 mg daily, desloratadine 5 mg daily plus placebo (saline) nasal spray, or placebo (saline) nasal spray/placebo capsules. The primary efficacy variable was the change from baseline to day 14 in the total nasal symptom score, consisting of runny nose, sneezing, itchy nose, and nasal congestion symptom scores recorded twice daily (AM and PM) in patient diary cards. 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 < 0.001), azelastine nasal spray plus loratadine (P < 0.001), and desloratadine (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.

Administration, Oral↗

Fluticasone propionate/salmeterol combination compared with montelukast for the treatment of persistent asthma.

BACKGROUND: Asthma is a chronic disease characterized by inflammation and bronchoconstriction. Medications that are able to effectively treat both components are advantageous. OBJECTIVE: To compare the efficacy of an inhaled corticosteroid and a long-acting beta2-agonist combination product with a leukotriene antagonist for initial maintenance therapy in patients who were symptomatic while receiving short-acting beta2-agonists alone. METHODS: A 12-week, randomized, double-blind, double-dummy, multicenter study was conducted in 432 patients 15 years of age and older with persistent asthma who were symptomatic on short-acting beta2-agonists alone. Fluticasone propionate 100 microg and salmeterol 50 microg combination product (FSC) twice daily or montelukast 10 mg once daily was administered. RESULTS: At endpoint, compared with montelukast, FSC significantly increased morning predose forced expiratory volume in 1 second (0.61 +/- 0.03 L vs 0.32 +/- 0.03 L), morning peak expiratory flow rate (peak expiratory flow rate; 81.4 +/- 5.9 L/minute vs 41.9 +/- 4.8 L/minute), evening peak expiratory flow rate (64.6 +/- 5.3 L/minute vs 38.8 +/- 4.7 L/minute), the percentage of symptom-free days (40.3 +/- 2.9% vs 27.0 +/- 2.7%), the percentage of rescue-free days (53.4 +/- 2.8% vs 26.7 +/- 2.5%), and the percentage of nights with no awakenings (29.8 +/- 2.5% vs 19.6 +/- 2.1%) (P < or = 0.011, all comparisons). At endpoint, FSC significantly reduced asthma symptom scores (-1.0 +/- 0.1 vs -0.7 +/- 0.1) and rescue albuterol use (-3.6 +/- 0.2 puffs/day vs -2.2 +/- 0.2 puffs/day) compared with montelukast (P < 0.001). At endpoint, patients treated with FSC also had a significantly greater improvement in quality of life scores and were more satisfied with their treatment compared with montelukast-treated patients (P < or = 0.001). Both treatments were well tolerated. CONCLUSIONS: Initial maintenance therapy with FSC provides greater improvement in asthma control and patient satisfaction than montelukast.

Acetates↗

Rhinitis and rhinologic headaches.

Rhinologic headache, a headache of nasal origin, generally has been attributed to past facial trauma causing nasal mucosa-septal contact points. Patients who have not knowingly experienced nasal trauma may have contact points caused by mucosal inflammation or anatomic abnormalities (septal spurs, septal deviation, and enlarged turbinates) and can develop rhinologic headaches. A population of 66 such patients was studied to classify the type of patient susceptible to such headaches and to examine the type of underlying inflammation or anatomic abnormality responsible for creating their mucosal contact points. Most patients were women with a mean age at the time of initial presentation of 40 years. VMR was the most frequent cause of nasal inflammation, either alone or in combination with allergic rhinitis. Generally, headache symptoms improved with treatment of the underlying nasal inflammation in the majority of patients.

Adult↗