Onset of effect of budesonide and formoterol administered via one pressurized metered-dose inhaler in patients with asthma previously treated with inhaled corticosteroids.
BACKGROUND
Onset of bronchodilation of budesonide/formoterol in one pressurized metered-dose inhaler (pMDI) has not been evaluated in asthma.


OBJECTIVE
To evaluate time to onset of clinically significant bronchodilation (> or = 15% improvement in forced expiratory volume in 1 second) and patient-perceived onset of effect (OE) in patients previously receiving inhaled corticosteroids.


METHODS
In two 12-week studies, patients 12 years and older with moderate to severe (study 1; n = 596) and mild to moderate (study 2; n = 480) persistent asthma received budesonide/formoterol pMDI, budesonide pMDI plus formoterol dry powder inhaler (study 1 only), budesonide pMDI, formoterol dry powder inhaler, or placebo. Postdose time to 15% or greater improvement in forced expiratory volume in 1 second and patient-perceived OE (assessed in a subset of patients 18 years and older [study 1, n=553; study 2, n=405]) were evaluated [corrected]


RESULTS
More budesonide/formoterol-treated patients achieved onset of clinically significant bronchodilation within 15 minutes (median, 13 minutes) of administration at randomization vs those taking budesonide or placebo (P < .001). More patients receiving budesonide/formoterol vs budesonide and placebo reported feeling their study medication begin to work right away (P < or = .004; end of week 1). Similar results (P < .001) were observed for patient satisfaction with how quickly they felt their medication begin to work (except budesonide/formoterol vs budesonide, study 1 [P = .073]). Time to onset of clinically significant bronchodilation and patient-perceived OE of budesonide/formoterol and formoterol were similar.


CONCLUSIONS
Budesonide/formoterol demonstrated a more rapid onset of clinically significant bronchodilation and a greater percentage of patients who perceived their medication working right away vs budesonide or placebo.
Kaiser
Harold
H
Clinical Research Institute, Minneapolis, Minnesota, USA. hbk@allergy-asthma-docs.com
Parasuraman
Bhash
B
Boggs
Robert
R
Miller
Christopher J
CJ
Leidy
Nancy Kline
NK
O'Dowd
Liza
L
D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D017060:Patient Satisfaction; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate