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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

500 mcg, once daily, oral administration in the morning

The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

NCT ID

Therapeutic Area

Altana Pharma/Nycomed Investigational Site

Effect of roflumilast on exacerbation rate in patients with COPD. The AURA Study

Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]

Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].

Age Continuous

GenderNIH

ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.

Pre-bronchodilator Forced expiratory volume in first second (FEV1)

COPD exacerbation rate (moderate or severe)

Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]

ITT analysis. Number of participants analyzed = number of participants with data available.

Post-bronchodilator FEV1 [L]

ITT analysis. Number of participants analyzed = number of participants who died.

Time to mortality due to any reason

Mean change from baseline to the last post randomization measurement in natural log-transformed CRP

Natural log-transformed C-reactive protein (CRP)

The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.

Arms	Assigned Interventions
Active Comparator: Roflumilast 500 mcg, once daily, oral administration in the morning	Drug: Roflumilast 500 mcg, once daily, oral administration in the morning
Placebo Comparator: Placebo once daily	Drug: Placebo once daily

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

Official Title

Medical condition

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Healthy volunteers

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Verification:

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Documents available

Trial Results Summaries

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