A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily

AstraZeneca1 site in 1 country660 target enrollmentMay 2007

ConditionsChronic Obstructive Pulmonary Disease, COPD

InterventionsSymbicort (budesonide/formoterol turbuhaler 320/9ug)Spiriva (tiotropium bromide 18ug)

DrugsSymbicort (budesonide/formoterol turbuhaler 320/9ug)Spiriva (tiotropium bromide 18ug)

Overview

Phase: Phase 4
Intervention: Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Sponsor: AstraZeneca
Enrollment: 660
Locations: 1
Primary Endpoint: Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

June 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•\>=40 years of age, diagnosed COPD with symptoms \>=2 years, pre-bronchodilatory FEV1 \<=50% of PN

Exclusion Criteria

•Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder

Arms & Interventions

Symbicort+TIO

Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily

Intervention: Symbicort (budesonide/formoterol turbuhaler 320/9ug)

Spiriva® + Placebo Turbuhaler

Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily

Intervention: Spiriva (tiotropium bromide 18ug)

Outcomes

Primary Outcomes

Forced Expiratory Volume in 1 Second (FEV1) Pre-dose

Time Frame: Baseline to 12 weeks

Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)

Secondary Outcomes

Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose(Baseline to 12 weeks)
Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose(Baseline to 12 weeks)
Forced Vital Capacity (FVC) Pre-dose(Baseline to 12 weeks)
Morning Peak Expiratory Flow (PEF) 5 Min Post-dose(Baseline to 12 weeks)
Forced Vital Capacity (FVC) 5 Minutes Post-dose(Baseline to 12 weeks)
Forced Vital Capacity (FVC) 60 Minutes Post-dose(Baseline to 12 weeks)
Inspiratory Capacity (IC) Pre-dose(Baseline to 12 weeks)
Inspiratory Capacity (IC) 60 Minutes Post-dose(Baseline to 12 weeks)
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score(Baseline and 12 weeks)
Morning Peak Expiratory Flow (PEF) Pre-dose(Baseline to 12 weeks)
Evening Peak Expiratory Flow (PEF) Pre-dose(Baseline to 12 weeks)
Morning Peak Expiratory Flow (PEF) 15 Min Post-dose(Baseline to 12 weeks)
Morning Diary FEV1 Pre-dose(Baseline to 12 weeks)
Evening Diary FEV1, Pre-dose(Baseline to 12 weeks)
Morning Diary FEV1, 5 Minutes Post-dose(Baseline to 12 weeks)
Morning Diary FEV1, 15 Minutes Post-dose(Baseline to 12 weeks)
Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose(Baseline to 12 weeks)
GCSQ Score, 5 Minutes Post-dose(Baseline to 12 weeks)
GCSQ Score, 15 Minutes Post-dose(Baseline to 12 weeks)
Capacity of Day Living in the Morning (CDLM) Score(Baseline to 12 weeks)
Use of Rescue Medication, Night(Baseline to 12 weeks)
Use of Rescue Medication, Morning(Baseline to 12 weeks)
Use of Rescue Medication, Day(Baseline to 12 weeks)
Use of Rescue Medication, Total(Baseline to 12 weeks)
COPD Symptoms, Breathing Score(Baseline to 12 weeks)
COPD Symptoms, Sleeping Score(Baseline to 12 weeks)
COPD Symptoms, Chest Score(Baseline to 12 weeks)
COPD Symptoms, Cough Score(Baseline to 12 weeks)
Severe COPD Exacerbations(12 weeks)
Serum High-sensitivity C-reactive Protein (hsCRP)(Baseline to 12 weeks)
Serum Interleukin 6 (IL-6)(Baseline to 12 weeks)
Serum Interleukin 8 (IL-8)(Baseline to 12 weeks)
Serum Monocyte Chemoattractant Protein-1 (MCP-1)(Baseline to 12 weeks)
Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)(Baseline to 12 weeks)
Serum Tumor Necrosis Factor-alpha (TNF-alpha)(Baseline to 12 weeks)
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)(Baseline to 12 weeks)