Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Roflumilast — DRUG
  500 mcg, once daily, oral administration in the morning
• Placebo — DRUG
  once daily

Study Details

The aim of the study is to compare 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 be 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).

Key Dates

Start date

Mar 31, 2006

Status verified

Sep 2016

Primary completion

Apr 30, 2008

Completion

Aug 31, 2008

Study Design

Enrollment

1,568 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Roflumilast
  500 mcg, once daily, oral administration in the morning
• Placebo Comparator: Placebo
  once daily

Primary Outcome Measure

Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Change from baseline over 52 weeks of treatment ]

Locations (151)

Find similar trials in Bayou La Batre, AL

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