At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 793 enrolled

Drug / intervention

Budesonide/formoterol (Symbicort® Turbuhaler®) +1 moredrug

Likely dose

Budesonide/formoterol (Symbicort® Turbuhaler®) 4.5μgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01397890

NCT01397890Phase 4Completed

Compare CT.gov

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

AstraZeneca·interventional·Posted Jul 20, 2011·Updated Mar 27, 2015

In Brief

A Phase 4 clinical trial evaluating Budesonide/formoterol (Symbicort® Turbuhaler®) and Tiotropium (SpirivaTM) for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 793 participants across 31 sites in 5 countries.

Detailed Summary

This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsChronic Obstructive Pulmonary Disease (COPD)

CountriesChina, Hong Kong, Indonesia, South Korea, Thailand

Collaborators--

Timeline

Phase 4CompletedFinished

201220132014201520162017201820192020202120222023202420252026

Enrollment StartJul 2011

First PostedJul 2011

Primary CompletionJun 2013

TodayJul 2026

First PostedJul 20, 2011

Enrollment StartJul 1, 2011

Primary CompletionJun 1, 2013

TodayJul 2, 2026

Enrollment to primary: 1.9 yearsPosted 15.0 years ago

Interventions

Budesonide/formoterol (Symbicort® Turbuhaler®)drug

Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily

Tiotropium (SpirivaTM)drug

Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily