efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD) - SECURE 1

Study identifier:D589BL00023

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomised, parallel-group, open-label, multicentre, 3-month phase IV, efficacy and tolerability study of budesonide/formoterol (Symbicort® Turbuhaler® 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (SpirivaTM 18 μg/inhalation, 1 inhalation once daily) compared with tiotropium (SpirivaTM18 μg/inhalation, 1 inhalation once daily) alone in severe chronic obstructive pulmonary disease (COPD) patients

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 4

Healthy volunteers

No

Study drug

Budesonide/formoterol (Symbicort® Turbuhaler®), Tiotropium (SpirivaTM)

Sex

All

Actual Enrollment

793

Study type

Interventional

Age

40 Years - 99 Years

Date

Study Start Date: 01 Jul 2011
Primary Completion Date: 01 Jun 2013
Study Completion Date: 01 Jun 2013

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2015 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria