Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01473758
• Date of registration: 31/10/2011
• Primary sponsor: Nycomed: A Takeda Company
• Public title: Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease TREAT
• Scientific title: Effect of Roflumilast 500 µg Tablets Once Daily at Acute COPD Exacerbations Treated With Standard Therapy of Oral Steroids and Antibiotics. A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial
• Date of first enrolment: February 2012
• Target sample size: 140
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01473758
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United Kingdom

Contacts

• Name: Takeda Study Registration Call Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written informed consent (IC)

- Age = 40 years

- History of COPD for at least 12 months prior to enrollment (Visit V0)

- Chronic productive cough for 3 months in each of the 2 years prior to enrollment (if
other causes of productive cough have been excluded) and/or an exacerbation with
predominantly bronchitic symptoms at enrollment

- Presentation of an acute exacerbation of COPD that will be associated with increased
sputum volume or change in sputum colour

- Documented fixed airway obstruction determined by an FEV1/FVC ratio
(post-bronchodilator) < 70% (if a pulmonary function test is not possible at Visit V0
a previous measurement can be taken which must not be older than 6 months)

- Former smoker (defined as: smoking cessation at least 1 year ago) or current smoker
both with a smoking history of at least 10 pack years

Main Exclusion Criteria:

- Diagnosis of asthma and/or other relevant lung disease

- Known alpha-1-antitrypsin deficiency

- Recurrent exacerbations (within 8 weeks of a preceding exacerbation)

- Treatment of current exacerbation with oral corticosteroids and/or antibiotics
already started at enrollment

- Treatment with PDE4 inhibitors within 3 months prior to Visit V0

- Other protocol-defined exclusion criteria may apply



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Intervention(s)

Drug: Placebo

Drug: Roflumilast

Primary Outcome(s)

Change in sputum neutrophil counts [cells/g sputum] from Day 1 to Day 14 post exacerbation [Time Frame: Day 1 to Day 14]

Secondary Outcome(s)

Change in blood biomarkers [Time Frame: Day 1 to Day 7, Day 14, Day 28, Day 56]

Change in pulmonary function [Time Frame: Day 1 to Day 7, Day 14, Day 28, Day 56]

Change in sputum inflammatory markers [Time Frame: Day 1 to Day 7, Day 14, Day 28, Day 56]

Diary outcomes [Time Frame: During treatment and follow-up period (up to 56 days)]

Patient-reported outcomes [Time Frame: During treatment and follow-up period (up to 56 days)]

Secondary ID(s)

2011-002905-31

RO-2455-405-RD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors