efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients - SECURE2

Study identifier:D589BL00022

ClinicalTrials.gov identifier:NCT01415518

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Efficacy and tolerability study of Symbicort Turbuhaler(160/4.5µg/inhalation,2inhalations twice daily) added to Atrovent (20µg/inhalation, 2 inhalations 4 times daily)+theophylline SR(0.1g/tablet,1 tablet p.o. twice daily) compared with Atrovent+theophylline SR in severe COPD patients.

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 4

Healthy volunteers

No

Study drug

Drug: Budesonide/formoterol (Symbicort Turbuhaler, Drug: ipratropium (AtroventTM), theophylline SR

Sex

All

Actual Enrollment

581

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Sept 2011
Primary Completion Date: 01 Dec 2012
Study Completion Date: 01 Dec 2012

Study design

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

Verification:

Verified 01 Jun 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria