* 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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
109
Formoterol Turbuhaler 9 μg and Placebo Diskus
Salmeterol Diskus 50 μg and Placebo Turbuhaler
Placebo Diskus and Placebo Turbuhaler
Research Site
Bussolengo, Italy
Research Site
Cassano delle Murge, Italy
Research Site
Catanzaro, Italy
FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose
FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1
Time frame: Pre-dose and 5 minutes post-dose
Average FEV1 During the First 15 Minutes Post Dose
Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1
Time frame: Pre dose and 15 minutes post dose
Average FEV1 During 120 Minutes Post Dose
Average FEV1 during 120 minutes post dose, change versus pre dose FEV1
Time frame: Pre dose and 120 minutes post dose
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1
Time frame: Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose
Adverse Events
Number of participants with at least 1 AE.
Time frame: At baseline and at each day of treatment
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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
...and 7 more locations