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)

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2013

Interventions

  • Drug: Budesonide/formoterol (Symbicort® Turbuhaler®)
    • Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily
  • Drug: Tiotropium (SpirivaTM)
    • Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily

Arms, Groups and Cohorts

  • Other: 1
    • Add-on treatment
  • Other: 2
    • Add-on treatment

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Post-dose FEV1 at 5 Minutes
    • Time Frame: Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug
    • Ratio of post-dose FEV1 at 5 minutes to baseline value
  • Post-dose FEV1 at 60 Minutes
    • Time Frame: 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)
    • Ratio of post-dose FEV1 at 60 minutes to baseline value
  • Pre-dose FVC
    • Time Frame: 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)
    • Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value
  • Post-dose FVC at 5 Minutes
    • Time Frame: 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)
    • Ratio of post-dose FVC at 5 minutes to baseline value
  • Post-dose FVC at 60 Minutes
    • Time Frame: 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)
    • Ratio of post-dose FVC at 60 minutes to baseline value
  • Pre-dose IC
    • Time Frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug
    • Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value
  • Post-dose IC at 60 Minutes
    • Time Frame: 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)
    • Ratio of post-dose IC at 60 minutes to baseline value
  • Pre-dose PEF in Last Week of Treatment
    • Time Frame: 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
    • Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment
  • Pre-dose PEF in First Week of Treatment
    • Time Frame: 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
    • Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to first week of treatment
  • Pre-dose PEF in Whole Treatment Period
    • Time Frame: 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
    • Change in pre-dose morning PEF from run-in period to whole treatment period
  • Post-dose PEF in Last Week of Treatment
    • Time Frame: 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
    • Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment
  • Post-dose PEF in First Week of Treatment
    • Time Frame: 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
    • Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment
  • Post-dose PEF in Whole Treatment Period
    • Time Frame: 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
    • Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period
  • Use of Reliever Medication During Day in the Last Week on Treatment
    • Time Frame: 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
    • Change in the number of inhalations of reliever medication during day from run-in period to the last week on treatment
  • Use of Reliever Medication During Day in the First Week on Treatment
    • Time Frame: 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
    • Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment
  • Use of Reliever Medication During Day in the Whole Treatment Period
    • Time Frame: 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 the number of inhalations of reliever medication during day from run-in period to the whole treatment period
  • Use of Reliever Medication During Night in the Last Week on Treatment
    • Time Frame: 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
    • Change in the number of inhalations of reliever medication during night from run-in period to the last week on treatment
  • Use of Reliever Medication During Night in the First Week on Treatment
    • Time Frame: 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
    • Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment
  • Use of Reliever Medication During Night in the Whole Treatment Period
    • Time Frame: 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 the number of inhalations of reliever medication during night from run-in period to the whole treatment period
  • Change in COPD Symptoms – Breathing
    • Time Frame: 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 breathing symptom score (from 0:none to 4:severe) from run-in period
  • Change in COPD Symptoms – Cough
    • Time Frame: 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 Cough symptom score (from 0:none to 4:severe) from run-in period
  • Change in COPD Symptoms – Sputum
    • Time Frame: 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 Sputum symptom score (from 0:none to 4:severe) from run-in period
  • COPD Exacerbations
    • Time Frame: Whole treatment period of 12 weeks
    • Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Samuel Chen, M.D., Study Chair, AstraZeneca Pharmaceutical Co., Ltd., Shanghai, China

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.