CLINICAL TRIALS PROFILE FOR ROFLUMILAST
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All Clinical Trials for Roflumilast
| Trial ID | Title | Status | Sponsor | Phase | Start Date | 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 | 2003-06-01 | 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 | 2003-11-01 | 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 | 2003-12-01 | 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 | 2003-12-01 | 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 | 2004-10-01 | 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 | 2004-05-01 | 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. |
| NCT00163527 ↗ | Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013) | Completed | Pfizer | Phase 3 | 2003-04-01 | 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 investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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