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) (SECURE 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01397890
First received: June 27, 2011
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Budesonide/formoterol (Symbicort® Turbuhaler®)
Drug: Tiotropium (SpirivaTM)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pre-dose FEV1 [ Time Frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug ] [ Designated as safety issue: No ]
    Ratio of pre-dose FEV1 (Forced Expriratory Volume in 1 second) in treatment period to baseline value


Secondary Outcome 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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Ratio of post-dose FEV1 at 60 minutes to baseline value

  • Pre-dose FVC [ Time Frame: Baseline (meaured 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) ] [ Designated as safety issue: No ]
    Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value

  • Post-dose FVC at 5 Minutes [ Time Frame: Baseline (meaured 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value

  • Post-dose IC at 60 Minutes [ Time Frame: Baseline (meaured 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of inhalations of reliever medication during day in 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 ] [ Designated as safety issue: No ]
    Number of inhalations of reliever medication during day in 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 ] [ Designated as safety issue: No ]
    Number of inhalations of reliever medication during day in 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 ] [ Designated as safety issue: No ]
    Number of inhalations of reliever medication during night in 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 ] [ Designated as safety issue: No ]
    Number of inhalations of reliever medication during day in 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 ] [ Designated as safety issue: No ]
    Number of inhalations of reliever medication during night in 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 ] [ Designated as safety issue: No ]
    Change in breathing symptom score (from 0 to 4) 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 ] [ Designated as safety issue: No ]
    Change in Cough symptom score (from 0 to 4) 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 ] [ Designated as safety issue: No ]
    Change in Sputum symptom score (from 0 to 4) from run-in period

  • COPD Exacerbations [ Time Frame: Whole treatment period of 12 weeks ] [ Designated as safety issue: No ]
    Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms


Enrollment: 793
Study Start Date: July 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Add-on treatment
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
2
Add-on treatment
Drug: Tiotropium (SpirivaTM)
Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397890

Locations
China
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Changsha, China
Research Site
Guang Zhou, China
Research Site
Guangzhou, China
Research Site
Shanghai, China
Research Site
Shen Yang, China
Research Site
Taiyuan, China
Hong Kong
Research Site
Hong kong, Hong Kong
Research Site
Hongkong, Hong Kong
Research Site
Kowloon, Hong Kong
Indonesia
Research Site
Jakarta, Indonesia
Research Site
Solo, Indonesia
Research Site
Surabaya, Indonesia
Korea, Republic of
Research Site
Busan, Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Gwangju, Korea, Republic of
Research Site
Incheon, Korea, Republic of
Research Site
Jinju-si, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Suwon-si, Korea, Republic of
Research Site
Wonju-si, Korea, Republic of
Thailand
Research Site
Bangkok, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Chonburi, Thailand
Research Site
Khon Kaen, Thailand
Research Site
Muang,, Thailand
Research Site
Phitsanulok, Thailand
Research Site
Songkhla, Thailand
Research Site
Udon Thani, Thailand
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Samuel Chen, M.D. AstraZeneca Pharmaceutical Co., Ltd., Shanghai, China
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01397890     History of Changes
Other Study ID Numbers: D589BL00023
Study First Received: June 27, 2011
Results First Received: June 18, 2014
Last Updated: August 12, 2014
Health Authority: China: Ethics Committee, Ministry of Health, National Natural Science Foundation, State Food and Drug Administration
Hong Kong: Department of Health, Joint CUHK-NTEC Clinical Research Ethics Committee
Hong Kong: HKU/HA HKW IRB, NTW Cluster Clinical & Research Ethics Committee, Clinical Research Ethics Committee, Kowloon West Cluster
Indonesia: Departement Kesehatan (Department of Health, National Agency of Drug and Food Control, Ethics Committee
Korea: Food and Drug Administration
Thailand: Ethical Committee, Ministry of Public Health, Food and Drug Administration

Keywords provided by AstraZeneca:
Severe chronic obstructive pulmonary disease (COPD) patients

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Formoterol
Tiotropium
Budesonide
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014