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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR ROFLUMILAST

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Clinical Trials for Roflumilast

Trial ID Title Status Sponsor Phase Summary
NCT00062582 Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110) Completed AstraZeneca Phase 3 The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.
NCT00073177 Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012) Completed AstraZeneca Phase 3 The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.
NCT00076076 The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023) Completed AstraZeneca Phase 3 The purpose of this study is to confirm the dose of roflumilast to be used for asthma management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on pulmonary function and asthma symptoms.
NCT00076089 OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111) Completed AstraZeneca Phase 3 The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
NCT00108823 The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121) Completed AstraZeneca Phase 3 The purpose of this trial is to study the effects of roflumilast on lung function parameters indicative of hyperinflation in patients with COPD.
NCT00163475 Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015) Completed AstraZeneca Phase 3 Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma. The aim of the study is to compare the effect of roflumilast on lung function, symptoms, and use of rescue medication in patients with stable asthma. Roflumilast will be administered orally either in the morning or in the evening at one dose level. The study duration consists of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Roflumilast

Condition Name

Condition Name for Roflumilast
Intervention Trials
Chronic Obstructive Pulmonary Disease 14
COPD 13
Chronic Obstructive Pulmonary Disease (COPD) 8
Asthma 6
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Condition MeSH

Condition MeSH for Roflumilast
Intervention Trials
Pulmonary Disease, Chronic Obstructive 32
Lung Diseases 30
Lung Diseases, Obstructive 28
Asthma 9
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Clinical Trial Locations for Roflumilast

Trials by Country

Trials by Country for Roflumilast
Location Trials
United States 282
Canada 20
United Kingdom 12
Germany 12
Spain 12
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Trials by US State

Trials by US State for Roflumilast
Location Trials
California 11
Texas 10
Florida 10
New York 9
Maryland 9
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Clinical Trial Progress for Roflumilast

Clinical Trial Phase

Clinical Trial Phase for Roflumilast
Clinical Trial Phase Trials
Phase 4 11
Phase 3 20
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Roflumilast
Clinical Trial Phase Trials
Completed 44
Recruiting 10
Active, not recruiting 3
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Clinical Trial Sponsors for Roflumilast

Sponsor Name

Sponsor Name for Roflumilast
Sponsor Trials
AstraZeneca 27
Takeda 11
Mitsubishi Tanabe Pharma Corporation 4
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Sponsor Type

Sponsor Type for Roflumilast
Sponsor Trials
Industry 53
Other 30
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cerilliant
Accenture
Fish and Richardson
QuintilesIMS
Mallinckrodt
Healthtrust
Merck
Julphar

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