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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR FORMOTEROL FUMARATE; MOMETASONE FUROATE

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Clinical Trials for Formoterol Fumarate; Mometasone Furoate

Trial ID Title Status Sponsor Phase Summary
NCT00381485 Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED) Completed Novartis Phase 3 This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg 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 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).
NCT00381485 Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg 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 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).
NCT00383240 Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED) Completed Novartis Phase 3 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.
NCT00383240 Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 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.
NCT00383435 Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED) Completed Novartis Phase 3 This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated subjects who will not participate in the safety extension will be discontinued and will have their Final Visit at Week 26. Subjects who continue into the 26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12hr]) and change from Baseline to Week 13 in AM predose FEV1.
NCT00383435 Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated subjects who will not participate in the safety extension will be discontinued and will have their Final Visit at Week 26. Subjects who continue into the 26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12hr]) and change from Baseline to Week 13 in AM predose FEV1.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Formoterol Fumarate; Mometasone Furoate

Condition Name

Condition Name for Formoterol Fumarate; Mometasone Furoate
Intervention Trials
Asthma 12
Chronic Obstructive Pulmonary Disease (COPD) 2
Healthy 1
COPD 1
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Condition MeSH

Condition MeSH for Formoterol Fumarate; Mometasone Furoate
Intervention Trials
Asthma 11
Pulmonary Disease, Chronic Obstructive 3
Lung Diseases, Obstructive 2
Lung Diseases 2
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Clinical Trial Locations for Formoterol Fumarate; Mometasone Furoate

Trials by Country

Trials by Country for Formoterol Fumarate; Mometasone Furoate
Location Trials
United States 16
Colombia 2
Latvia 1
Russian Federation 1
Peru 1
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Trials by US State

Trials by US State for Formoterol Fumarate; Mometasone Furoate
Location Trials
Florida 2
California 2
Wisconsin 1
Virginia 1
Texas 1
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Clinical Trial Progress for Formoterol Fumarate; Mometasone Furoate

Clinical Trial Phase

Clinical Trial Phase for Formoterol Fumarate; Mometasone Furoate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 9
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Formoterol Fumarate; Mometasone Furoate
Clinical Trial Phase Trials
Completed 13
Recruiting 1
Withdrawn 1
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Clinical Trial Sponsors for Formoterol Fumarate; Mometasone Furoate

Sponsor Name

Sponsor Name for Formoterol Fumarate; Mometasone Furoate
Sponsor Trials
Merck Sharp & Dohme Corp. 13
Novartis 8
Schering-Plough 2
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Sponsor Type

Sponsor Type for Formoterol Fumarate; Mometasone Furoate
Sponsor Trials
Industry 23
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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Daiichi Sankyo
Mallinckrodt
Colorcon
Covington
UBS
Queensland Health
Citi
Merck

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