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

AstraZeneca1 site in 1 country793 target enrollmentJuly 2011

ConditionsChronic Obstructive Pulmonary Disease (COPD)

InterventionsBudesonide/formoterol (Symbicort® Turbuhaler®)Tiotropium (SpirivaTM)

DrugsBudesonide/formoterol (Symbicort® Turbuhaler®)Tiotropium (SpirivaTM)

Overview

Phase: Phase 4
Intervention: Budesonide/formoterol (Symbicort® Turbuhaler®)
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: AstraZeneca
Enrollment: 793
Locations: 1
Primary Endpoint: Pre-dose FEV1
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

June 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed and dated informed consent
•Men or women patients ≥40 years of age
•Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
•Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) \< 70%, pre-bronchodilator
•Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period

Exclusion Criteria

•A history of asthma and seasonal allergic rhinitis before 40 years of age
•Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period and also the patients who use of systemic glucocorticosteroids (GCS) within 4 weeks and/or inhaled GCS within 2 weeks prior to Visit 2 and/or during run-in period
•Patients with relevant cardiovascular disorder judged by the investigator
•Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
•Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator

Arms & Interventions

1

Add-on treatment

Intervention: Budesonide/formoterol (Symbicort® Turbuhaler®)

1

Add-on treatment

Intervention: Tiotropium (SpirivaTM)

2

Add-on treatment

Intervention: Tiotropium (SpirivaTM)

Outcomes

Primary Outcomes

Pre-dose FEV1

Time Frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug

Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value

Secondary Outcomes

Post-dose FEV1 at 5 Minutes(Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug)
Post-dose FEV1 at 60 Minutes(Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12))
Pre-dose IC(Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug)
Pre-dose PEF in Last Week of Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment, up to 12 weeks)
Post-dose PEF in Last Week of Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment, up to 12 weeks)
Pre-dose FVC(Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12))
Pre-dose PEF in First Week of Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the first week of treatment)
Post-dose PEF in First Week of Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the first week of treatment)
Post-dose PEF in Whole Treatment Period(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period of 12 weeks)
Use of Reliever Medication During Night in the Whole Treatment Period(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks)
Change in COPD Symptoms - Cough(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks)
Change in COPD Symptoms - Sputum(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks)
Post-dose FVC at 5 Minutes(Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12))
Post-dose IC at 60 Minutes(Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12))
Use of Reliever Medication During Day in the First Week on Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment)
Post-dose FVC at 60 Minutes(Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12))
Change in COPD Symptoms - Breathing(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks)
Use of Reliever Medication During Night in the Last Week on Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks)
Pre-dose PEF in Whole Treatment Period(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period of 12 weeks)
Use of Reliever Medication During Day in the Last Week on Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks)
Use of Reliever Medication During Day in the Whole Treatment Period(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks)
Use of Reliever Medication During Night in the First Week on Treatment(Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment)
COPD Exacerbations(Whole treatment period of 12 weeks)