Newly Released Data on Onset of Effect and Patient Perception With SYMBICORT in Adults W... (placebo reported feeling their study med...)

Newly Released Data on Onset of Effect and Patient Perception With SYMBICORT in Adults With Asthma

Date:9/10/2008

placebo reported feeling their study medication begin to work right away (P less than or equal to .004; end of week 1).(1) Similar results (P<.001) were observed for patients' satisfaction with how quickly they felt their medication begin to work (except for SYMBICORT versus budesonide pMDI in Study 1 [P=.073]).(1) The results seen at the end of treatment were similar to those demonstrated at randomization.(1) Patient perception of onset of effect of SYMBICORT and formoterol DPI were similar.(1)

In both studies, the majority of reported adverse events were mild or moderate in intensity.(3,4) The most common adverse events reported in Study I were headache, upper respiratory tract infection and nasopharyngitis, also known as the common cold.(3) The most common adverse events reported in Study II were nasopharyngitis, headache and pharyngolaryngeal pain.(4)

About the Design of Study I and Study II

Onset of bronchodilation and patient perception of onset of effect was assessed in two 12-week randomized, double-blind, placebo-controlled studies in asthma patients who were previously treated with inhaled corticosteroids (ICS),(1) either alone or in combination with other asthma maintenance therapy. Study I involved 596 patients ages 12 years and older with moderate to severe persistent asthma; Study II involved 480 patients ages 12 years and older with mild to moderate persistent asthma.(1) Each study included a two-week run-in period during which patients discontinued use of their current asthma therapy and received single-blind budesonide pMDI 80 micrograms (mcg) two inhalations twice-daily (Study I) or placebo (Study II) and albuterol as needed for rescue.(1)

After run-in, patients within Study I were randomized to receive treatment with two inhalations twice-daily of SYMBICORT 160/4.5 mcg, two inhalations twice-daily of budesonide pMDI 160 mcg + two inhalations twice-daily of formoterol DPI 4.5 mcg, two inhalations twice-daily of budesonid
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Newly Released Data on Onset of Effect and Patient Perception With SYMBICORT in Adults W...(placebo reported feeling their study med...),Health