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A Randomised, Placebo-controlled, Double-blind (Double-dummy Technique),Crossover, Multi-centre Study, to Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler® 9 μg, Compared With Serevent® Diskus® 50 μg.
* Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose. * Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Research Site
Bussolengo, Italy
Research Site
Cassano delle Murge, Italy
Research Site
Catanzaro, Italy
Research Site
Cava de' Tirreni, Italy
Research Site
Naples, Italy
Research Site
Palermo, Italy
Research Site
Parma, Italy
Research Site
Pisa, Italy
Research Site
Prato, Italy
Research Site
Roma, Italy
Start Date
January 1, 2010
Primary Completion Date
May 1, 2010
Completion Date
May 1, 2010
Last Updated
October 25, 2012
109
ACTUAL participants
Formoterol
DRUG
Salmeterol
DRUG
Placebo
DRUG
Lead Sponsor
AstraZeneca
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
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