Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Completed
Sunovion
Phase 3
2005-10-01
To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a
period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)
Completed
Novartis
Phase 3
2006-09-01
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled,
parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate
(F)[MF/F] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week
double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily
(BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under
the Curve From 0 to 12 Hours [AUC](0-12 hours) of the Change From Baseline to the Week 12
Endpoint
in Forced Expiratory Volume in One Second (FEV1) [Time Frame: Baseline to Week 12] and
Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)
Completed
Merck Sharp & Dohme Corp.
Phase 3
2006-09-01
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled,
parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate
(F)[MF/F] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week
double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily
(BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under
the Curve From 0 to 12 Hours [AUC](0-12 hours) of the Change From Baseline to the Week 12
Endpoint
in Forced Expiratory Volume in One Second (FEV1) [Time Frame: Baseline to Week 12] and
Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.
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