Once daily intranasal fluticasone propionate is effective for perennial allergic rhinitis.

The efficacy of intranasal fluticasone propionate 200 micrograms once daily or 100 micrograms twice daily in treating perennial allergic rhinitis was evaluated in a randomized, double-blind, placebo-controlled study of 24 weeks' duration in 365 patients. Clinician-rated and patient-rated total nasal symptom severity scores were improved within 1 week of treatment with either regimen of fluticasone propionate and improvement was maintained over the 24-week treatment period. Clinician-rated overall evaluation indicated a significantly better response in the two fluticasone propionate groups compared with the placebo group. All efficacy evaluations indicated no difference in response between the fluticasone propionate 200 micrograms once-daily and 100 micrograms twice-daily groups. Patients in both fluticasone propionate groups had significantly less nasal obstruction upon awakening than the placebo group at all assessment periods. Fewer patients in either fluticasone propionate group used antihistamine rescue medication compared with the placebo group. The percentage of patients with nasal eosinophils and basophils at the end of the 24-week treatment period was significantly lower in both fluticasone propionate groups compared with the placebo group. Safety evaluations indicated that intranasal fluticasone propionate was as safe as placebo when given as 200 micrograms once daily or 100 micrograms twice daily. The incidence of drug-related adverse events was similar among the fluticasone propionate and placebo groups except for the incidence of epistaxis and blood in nasal mucus which was somewhat higher in the fluticasone propionate twice-daily group. There was no changes in the opthalmic examinations to suggest corticosteriod-induced posterior subcapsular cataract formation.(ABSTRACT TRUNCATED AT 250 WORDS)

Double-blind assessment of azelastine in the treatment of perennial allergic rhinitis.

Azelastine is a chemically novel multifunctional antiallergy investigational drug capable of inhibiting mast-cell activation and the synthesis and/or release of chemical mediators of the upper and lower airway inflammatory response. In previous controlled clinical trials, azelastine was shown to be effective in treating the symptoms of both seasonal allergic rhinitis and perennial allergic rhinitis. The objective of this 8-week double-blind trial was to evaluate further azelastine's efficacy and safety in improving the symptoms of perennial allergic rhinitis over a prolonged period of treatment. One hundred ninety-nine patients with symptomatic perennial allergic rhinitis were randomized to receive in a double-blind fashion azelastine, 2 mg bid, clemastine fumarate, 1.34 mg bid, or placebo bid for 8 weeks. Patients treated with azelastine had superior mean percent improvements in the total symptom complex score (nose blows, sneezes, stuffy nose, runny nose, itchy nose, and itchy eyes/ears/throat) versus placebo at each evaluation point and overall across all 8 weeks (P < .01) of the trial. Improvements in the individual symptoms of rhinitis were statistically significant (P < or = .04) for nose blows, sneezes, runny nose, itchy nose, and itchy eyes, ears, and throat. Treatment with azelastine also resulted in a clinically meaningful improvement in nasal congestion. Improvement in congestion was accompanied by a decreased requirement for backup decongestant medication. The adverse experiences were generally mild and well tolerated. Azelastine provided effective prolonged relief of the symptoms of perennial allergic rhinitis with no adverse effects that would limit its long-term use.

Safety and efficacy of terfenadine/pseudoephedrine versus clemastine/phenylpropanolamine in the treatment of seasonal allergic rhinitis.

A double-blind, randomized, placebo-controlled, parallel trial was conducted to compare the efficacy and safety of terfenadine, 60 mg (immediate-release)/pseudoephedrine hydrochloride, 120 mg (controlled-release) (T/Ps) and clemastine fumarate, 1.34 mg (immediate-release)/phenylpropanolamine, 75 mg (sustained-release) (C/Ph) in a combination tablet b.i.d. in 178 patients (12-59 years of age) with symptoms of seasonal allergic rhinitis. After seven days of treatment, the total symptom scores recorded in the diaries of 175 patients showed that both therapies had a highly significant overall treatment effect when compared with placebo (P < or = .02). The overall level of improvement, as well as improvement of individual symptoms, was similar with the two therapies. Total symptom scores assigned by physicians to 170 patients showed significant and similar levels of improvement with both therapies when compared with placebo (P < .01). The two therapies were also similar on physicians' evaluations of overall effectiveness. Both therapies relieved most histamine-mediated symptoms as well as nasal congestion, although only T/Ps showed improvement of the latter symptom in both the patients' diaries and physicians' evaluations. Among 178 patients, drowsiness and fatigue occurred more often in the C/Ph group (25% and 11.7% for the two adverse events, respectively) than in the T/Ps group (10.2% and 1.7%, respectively). The incidence of insomnia and dry mouth/nose/throat was higher with T/Ps (23.7% and 11.9%, respectively) than with C/Ph (6.7% and 3.3%, respectively). No serious or unexpected adverse events were reported. These results indicate that T/Ps and C/Ph are both superior to placebo and equally effective in the treatment of symptoms of seasonal allergic rhinitis.(ABSTRACT TRUNCATED AT 250 WORDS)

Multicenter evaluation of the efficacy and safety of sustained-release diltiazem hydrochloride for the treatment of hypertension.

In a double-blind study, patients with mild-to-moderate hypertension were randomly assigned to receive placebo or increasing daily doses of a new sustained-release formulation of diltiazem: 180 mg, 360 mg, and 540 mg, each once daily for two weeks. The numbers of evaluable patients were 26 in the placebo group and 81 in the diltiazem group at week 2, 24 and 75 at week 4, and 23 and 65 at week 6. Changes from baseline in mean supine trough (before drug administration) systolic/diastolic blood pressures were +1.3/-2.7 mmHg after placebo and -4.7/-6.1 mmHg after diltiazem at week 2; -0.1/-1.7 mmHg after placebo and -7.2/-9.3 mmHg after diltiazem at week 4; and +0.4/-1.7 mmHg after placebo and -6.7/-10.2 mmHg after diltiazem at week 6. The changes were significantly greater after diltiazem than placebo. Increasing the daily dose of diltiazem from 360 mg to 540 mg produced more than proportional increases in mean plasma diltiazem concentrations but only minimal further reductions in blood pressure. Similar rates of adverse experiences were reported by the diltiazem-treated and placebo patients. Treatment was withdrawn in two diltiazem-treated patients because of abnormal electrocardiographic (ECG) changes that were considered to be related to the drug: elevated ST segment in one and first-degree atrioventricular block in the other. No other treatment-related ECG changes were noted. It is concluded that this new once-daily formulation of diltiazem is safe and effective in the treatment of mild-to-moderate hypertension.