Original articles: Asthma, rhinitis, other respiratory diseases
Mometasone furoate antagonizes AMP-induced bronchoconstriction in patients with mild asthma

https://doi.org/10.1067/mai.2000.105709Get rights and content

Abstract

Background: Mometasone furoate (MF) is a new potent corticosteroid for use in treating asthma. Objective: To test the lower range of the dose-response curve, effects of MF delivered by dry powder inhaler (DPI) on AMP-induced bronchoconstriction were compared with those of placebo. Methods: In a placebo-controlled, 3-phase cross-over, single-center, double-blind study, 15 patients with mild asthma were randomized to three 2-week treatment phases (separated by 4-week washout phases) with MF DPI 50 μg twice daily, MF DPI 100 μg twice daily, or placebo. AMP challenge was performed before and at the end of each treatment phase. Results: Thirteen patients completed all 3 phases and were included in the primary efficacy analysis. Treatment with MF DPI 50 μg twice daily or with MF DPI 100 μg twice daily significantly reduced the bronchoconstrictor response to AMP, displacing the dose-response curve to the right by 2.81 and 3.11 doubling dilutions, respectively, compared with placebo (P < .001). The improvement in FEV1 over the 2-week treatment phase was significantly (P ≤ .033) greater during treatment with MF DPI 50 μg or 100 μg twice daily than with placebo. Peak expiratory flow rate, wheezing scores, difficulty breathing scores, nocturnal awakenings requiring salbutamol, and puffs of salbutamol per day also indicated a greater improvement in respiratory function and symptoms of asthma with MF DPI 50 or 100 μg twice daily than with placebo. Both doses of MF DPI were well tolerated. Conclusions: Treatment with low doses of MF DPI decreased airway responsiveness to AMP challenge and improved secondary measures of pulmonary function and asthma symptoms. (J Allergy Clin Immunol 2000;105:906-11.)

Section snippets

Methods

This randomized, placebo-controlled, single-center, 3-phase cross-over, double-blind study was designed to evaluate the effect of 2 low doses of MF DPI on AMP-induced bronchoconstriction compared with placebo in patients previously maintained on inhaled β-agonists alone.

Demographics

This study included 7 female and 8 male patients between the ages of 21 and 49 years. All patients were white. There was a wide variation in patient PC20 before treatment. At the beginning of phase I, before the administration of any study medication, PC20 values ranged from 1.02 mg/mL to 79.37 mg/mL with a median of 3.15 mg/mL.

One patient discontinued the study during the first treatment phase and one during the second treatment phase (see Safety). Thirteen patients completed all 3 treatment

Discussion

Treatment with MF DPI at 2 low doses (50 and 100 μg BID) for 2 weeks successfully antagonized AMP-induced bronchoconstriction. The PC20 (expressed as doubling dilutions) increased by approximately 3-fold relative to placebo for both doses of MF DPI. Treatment with both doses also resulted in improvement in pulmonary function, patient-reported symptoms, and investigator assessments of response to therapy.

Airway inflammation is a major factor contributing to disease severity and bronchial

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    Reprint requests: Stephen T. Holgate, MD, DSc, Southampton General Hospital, Southampton University, Med I, Level D, Southampton, S016 6YD United Kingdom.

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