Evaluation of tolerability and pharmacokinetics of roflumilast, 250μg and 500μg, as add-on to standard COPD treatment to treat severe COPD - OPTIMIZE

Study identifier:RO-2455-302-RD

ClinicalTrials.gov identifier:NCT02165826

EudraCT identifier:2013-001788-21

CTIS identifier:N/A

Study Complete

Official Title

A multicenter, randomized, double-blind phase 3 study to evaluate tolerability and pharmacokinetics of 500 μg roflumilast once daily with an up-titration regimen in COPD, including an open-label down-titration period evaluating tolerability and pharmacokinetics of 250 μg roflumilast once daily in subjects not tolerating 500 μg roflumilast once-daily

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 3

Healthy volunteers

No

Study drug

Roflumilast, Roflumilast Placebo, Standard of Care COPD Treatment

Sex

All

Actual Enrollment

1323

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 May 2014
Primary Completion Date: 01 Sept 2015
Study Completion Date: 01 Sept 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria