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• W1971364452 abstract "RATIONALE: To evaluate measured onset of bronchodilation with budesonide/formoterol in a pMDI in patients with asthma previously receiving inhaled corticosteroids.METHODS: Two 12-week, randomized, double-blind, placebo-controlled, multicenter studies were conducted. Study I (SD-039-0717): after a 2-week run-in (2 inhalations bid budesonide pMDI 80 μg), patients with moderate-to-severe asthma received 2 inhalations bid budesonide/formoterol pMDI 160/4.5 μg (n=124), budesonide pMDI 160 μg + formoterol dry powder inhaler (DPI) 4.5 μg (n=115), budesonide pMDI 160 μg (n=109), formoterol DPI 4.5 μg (n=123), or placebo (n=125). Study II (SD-039-0716): after a 2-week run-in (current asthma therapy discontinued), patients with mild-to-moderate asthma received 2 inhalations bid budesonide/formoterol pMDI 80/4.5 μg (n=123), budesonide pMDI 80 μg (n=121), formoterol DPI 4.5 μg (n=114), or placebo (n=122). The time to achieve ≥15% FEV1 improvement after study medication was assessed.RESULTS: After the first dose of treatment (day of randomization [DOR]), the time to 15% FEV1 improvement was significantly (P<.001, Wilcoxon test) earlier with budesonide/formoterol pMDI versus budesonide pMDI and placebo and with formoterol DPI versus placebo in both studies. The percentages of patients achieving ≥15% FEV1 improvement within 15 minutes postdose on DOR were as follows: budesonide/formoterol pMDI (56.5% [I], 48.8% [II]); budesonide pMDI (5.5% [I], 5.8% [II]); formoterol DPI (56.9% [I], 57.0% [II]); budesonide pMDI + formoterol DPI (52.2% [I]); and placebo (5.6% [I], 8.2% [II]).CONCLUSIONS: Budesonide/formoterol pMDI demonstrated a rapid bronchodilatory response (within 15 minutes postdose), which is faster than budesonide pMDI or placebo and similar to formoterol DPI and budesonide pMDI + formoterol DPI. RATIONALE: To evaluate measured onset of bronchodilation with budesonide/formoterol in a pMDI in patients with asthma previously receiving inhaled corticosteroids. METHODS: Two 12-week, randomized, double-blind, placebo-controlled, multicenter studies were conducted. Study I (SD-039-0717): after a 2-week run-in (2 inhalations bid budesonide pMDI 80 μg), patients with moderate-to-severe asthma received 2 inhalations bid budesonide/formoterol pMDI 160/4.5 μg (n=124), budesonide pMDI 160 μg + formoterol dry powder inhaler (DPI) 4.5 μg (n=115), budesonide pMDI 160 μg (n=109), formoterol DPI 4.5 μg (n=123), or placebo (n=125). Study II (SD-039-0716): after a 2-week run-in (current asthma therapy discontinued), patients with mild-to-moderate asthma received 2 inhalations bid budesonide/formoterol pMDI 80/4.5 μg (n=123), budesonide pMDI 80 μg (n=121), formoterol DPI 4.5 μg (n=114), or placebo (n=122). The time to achieve ≥15% FEV1 improvement after study medication was assessed. RESULTS: After the first dose of treatment (day of randomization [DOR]), the time to 15% FEV1 improvement was significantly (P<.001, Wilcoxon test) earlier with budesonide/formoterol pMDI versus budesonide pMDI and placebo and with formoterol DPI versus placebo in both studies. The percentages of patients achieving ≥15% FEV1 improvement within 15 minutes postdose on DOR were as follows: budesonide/formoterol pMDI (56.5% [I], 48.8% [II]); budesonide pMDI (5.5% [I], 5.8% [II]); formoterol DPI (56.9% [I], 57.0% [II]); budesonide pMDI + formoterol DPI (52.2% [I]); and placebo (5.6% [I], 8.2% [II]). CONCLUSIONS: Budesonide/formoterol pMDI demonstrated a rapid bronchodilatory response (within 15 minutes postdose), which is faster than budesonide pMDI or placebo and similar to formoterol DPI and budesonide pMDI + formoterol DPI." @default.
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• W1971364452 date "2007-01-01" @default.
• W1971364452 modified "2023-09-23" @default.
• W1971364452 title "Measured Onset of Bronchodilation With Budesonide and Formoterol Administered via One Pressurized Metered-dose Inhaler (pMDI) in Patients With Asthma Previously Receiving Inhaled Corticosteroids" @default.
• W1971364452 doi "https://doi.org/10.1016/j.jaci.2006.12.342" @default.
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