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, Roflumilast, Roflumilast Placebo, Standard of Care COPD Treatment, Standard of Care COPD Treatment, 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