Newly Released Data on Onset of Effect and Patient Perception With SYMBICORT in Adults W...(e pMDI 160 mcg two inhalations twice-dai...),Health

Date:9/10/2008

e pMDI 160 mcg, two inhalations twice-daily of formoterol DPI 4.5 mcg, or placebo.(1) Patients within Study II after run-in were randomized to receive treatment with two inhalations twice-daily of SYMBICORT 80/4.5 mcg, two inhalations twice-daily of budesonide pMDI 80 mcg, two inhalations twice-daily of formoterol DPI 4.5 mcg or placebo.(1)

Onset of clinically significant bronchodilation was defined as the time to achieve a 15 percent improvement in FEV1 from the predose FEV1 after study medication was administered.(1) Forced expiratory volume in one second (FEV1) quantifies how much air a person can exhale during a forced breath in the first second of exhalation.(5)

About Patient Perception of Onset of Effect

In these studies, perception of onset of effect was assessed in two ways.(1) Patients completed the Onset of Effect Questionnaire(c)(OEQ), a validated self-administered questionnaire.(1) Answers to statements were recorded in an electronic diary at the end of weeks one through 12:(1) They included: during the past week (1.) you could tell your study medication was working; (2.) you could feel your study medication begin to work right away; (3.) you felt physical sensations shortly after taking your study medication that reassured you that it was working; and (4.) you were satisfied with how quickly you felt your study medication begin to work.(1) Each question in the OEQ was rated by patients using a five-point scale: "strongly disagree," "somewhat disagree," "neither agree nor disagree," "somewhat agree," or "strongly agree."(1)

In addition, patients were asked a single perception of onset of effect question -- "Can you feel your study medication working?" -- four times during the first hour post-dose at the clinic on the day of randomization, at the end of week 2, and at the last study visit at the end of week 12.(1)

About SYMBICORT

SYMBICORT is a combination therapy indicated for the long-term maintenance treatment
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