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)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Budesonide/formoterol (Symbicort® Turbuhaler®)
- Registration Number
- NCT01397890
- Lead Sponsor
- AstraZeneca
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 793
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Tiotropium (SpirivaTM) Add-on treatment 2 Tiotropium (SpirivaTM) Add-on treatment 1 Budesonide/formoterol (Symbicort® Turbuhaler®) Add-on treatment
- Primary Outcome Measures
Name Time Method Pre-dose FEV1 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 Outcome Measures
Name Time Method 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 Ratio of post-dose FEV1 at 5 minutes to baseline value
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) Ratio of post-dose FEV1 at 60 minutes to baseline value
Pre-dose IC 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
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 Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment
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 Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment
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) Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value
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 Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to 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 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 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 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 the number of inhalations of reliever medication during night from run-in period to the whole treatment period
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 Cough symptom score (from 0:none to 4:severe) from run-in period
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 Change in Sputum symptom score (from 0:none to 4:severe) from run-in period
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) Ratio of post-dose FVC at 5 minutes to baseline value
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) Ratio of post-dose IC at 60 minutes to baseline value
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 Change in the number of inhalations of reliever medication during day from run-in period to 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) Ratio of post-dose FVC at 60 minutes to baseline value
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 Change in breathing symptom score (from 0:none to 4:severe) from run-in period
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 Change in pre-dose morning PEF from run-in period to whole treatment period
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 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 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 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 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 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
COPD Exacerbations 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
Trial Locations
- Locations (1)
Research Site
🇹🇭Udon Thani, Thailand