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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR FORADIL

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Clinical Trials for FORADIL

Trial ID Title Status Sponsor Phase Summary
NCT00250679 Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease Completed Sunovion Phase 3 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).
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.
NCT00383552 Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(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/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, participants will receive open-label (OL) MF MDI 100 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) and by the time-to-first severe asthma exacerbation across the 26-week treatment period.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for FORADIL

Condition Name

Condition Name for FORADIL
Intervention Trials
Asthma 10
Chronic Obstructive Pulmonary Disease 8
Pulmonary Disease, Chronic Obstructive 4
Chronic Obstructive Pulmonary Disease (COPD) 4
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Condition MeSH

Condition MeSH for FORADIL
Intervention Trials
Pulmonary Disease, Chronic Obstructive 19
Lung Diseases, Obstructive 18
Lung Diseases 17
Asthma 9
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Clinical Trial Locations for FORADIL

Trials by Country

Trials by Country for FORADIL
Location Trials
United States 138
Canada 13
Australia 12
New Zealand 8
South Africa 7
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Trials by US State

Trials by US State for FORADIL
Location Trials
Florida 14
South Carolina 13
North Carolina 8
California 7
Texas 6
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Clinical Trial Progress for FORADIL

Clinical Trial Phase

Clinical Trial Phase for FORADIL
Clinical Trial Phase Trials
Phase 4 2
Phase 3 13
Phase 2 11
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Clinical Trial Status

Clinical Trial Status for FORADIL
Clinical Trial Phase Trials
Completed 27
Recruiting 2
Withdrawn 2
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Clinical Trial Sponsors for FORADIL

Sponsor Name

Sponsor Name for FORADIL
Sponsor Trials
Pearl Therapeutics, Inc. 5
Merck Sharp & Dohme Corp. 5
Novartis 4
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Sponsor Type

Sponsor Type for FORADIL
Sponsor Trials
Industry 31
Other 22
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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
UBS
Moodys
Queensland Health
Chubb
Express Scripts
Mallinckrodt
Teva
Citi

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