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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)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Budesonide/formoterol (Symbicort® Turbuhaler®)
Tiotropium (SpirivaTM)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Severe chronic obstructive pulmonary disease (COPD) patients

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Add-on treatment

Add-on treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Post-dose FEV1 at 5 Minutes
Ratio of post-dose FEV1 at 5 minutes to baseline value
Post-dose FEV1 at 60 Minutes
Ratio of post-dose FEV1 at 60 minutes to baseline value
Pre-dose FVC
Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value
Post-dose FVC at 5 Minutes
Ratio of post-dose FVC at 5 minutes to baseline value
Post-dose FVC at 60 Minutes
Ratio of post-dose FVC at 60 minutes to baseline value
Pre-dose IC
Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value
Post-dose IC at 60 Minutes
Ratio of post-dose IC at 60 minutes to baseline value
Pre-dose PEF in Last Week of Treatment
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
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
Change in pre-dose morning PEF from run-in period to whole treatment period
Post-dose PEF in Last Week of Treatment
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
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
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
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
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
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
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
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
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
Change in breathing symptom score (from 0:none to 4:severe) from run-in period
Change in COPD Symptoms - Cough
Change in Cough symptom score (from 0:none to 4:severe) from run-in period
Change in COPD Symptoms - Sputum
Change in Sputum symptom score (from 0:none to 4:severe) from run-in period
COPD Exacerbations
Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms

Full Information

First Posted
June 27, 2011
Last Updated
March 25, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01397890
Brief Title
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)
Acronym
SECURE 1
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Severe chronic obstructive pulmonary disease (COPD) patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
793 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Add-on treatment
Arm Title
2
Arm Type
Other
Arm Description
Add-on treatment
Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol (Symbicort® Turbuhaler®)
Intervention Description
Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily
Intervention Type
Drug
Intervention Name(s)
Tiotropium (SpirivaTM)
Intervention Description
Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily
Primary Outcome Measure Information:
Title
Pre-dose FEV1
Description
Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value
Time Frame
Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug
Secondary Outcome Measure Information:
Title
Post-dose FEV1 at 5 Minutes
Description
Ratio of post-dose FEV1 at 5 minutes to baseline value
Time Frame
Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug
Title
Post-dose FEV1 at 60 Minutes
Description
Ratio of post-dose FEV1 at 60 minutes to baseline value
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)
Title
Pre-dose FVC
Description
Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value
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)
Title
Post-dose FVC at 5 Minutes
Description
Ratio of post-dose FVC at 5 minutes to baseline value
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)
Title
Post-dose FVC at 60 Minutes
Description
Ratio of post-dose FVC at 60 minutes to baseline value
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)
Title
Pre-dose IC
Description
Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value
Time Frame
Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug
Title
Post-dose IC at 60 Minutes
Description
Ratio of post-dose IC at 60 minutes to baseline value
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)
Title
Pre-dose PEF in Last Week of Treatment
Description
Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to 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
Title
Pre-dose PEF in First Week of Treatment
Description
Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to 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
Title
Pre-dose PEF in Whole Treatment Period
Description
Change in pre-dose morning PEF from run-in period to 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
Title
Post-dose PEF in Last Week of Treatment
Description
Change in post-dose morning PEF at 5 minutes from run-period to 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
Title
Post-dose PEF in First Week of Treatment
Description
Change in post-dose morning PEF at 5 minutes from run-in period to 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
Title
Post-dose PEF in Whole Treatment Period
Description
Change in post-dose morning PEF at 5 minutes from run-period to 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
Title
Use of Reliever Medication During Day in the Last Week on Treatment
Description
Change in the number of inhalations of reliever medication during day from run-in period to 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
Title
Use of Reliever Medication During Day in the First Week on Treatment
Description
Change in the number of inhalations of reliever medication during day from run-in period to 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
Title
Use of Reliever Medication During Day in the Whole Treatment Period
Description
Change in the number of inhalations of reliever medication during day from run-in period to 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
Title
Use of Reliever Medication During Night in the Last Week on Treatment
Description
Change in the number of inhalations of reliever medication during night from run-in period to 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
Title
Use of Reliever Medication During Night in the First Week on Treatment
Description
Change in the number of inhalations of reliever medication during day from run-in period to 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
Title
Use of Reliever Medication During Night in the Whole Treatment Period
Description
Change in the number of inhalations of reliever medication during night from run-in period to 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
Title
Change in COPD Symptoms - Breathing
Description
Change in breathing symptom score (from 0:none to 4:severe) from run-in period
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
Title
Change in COPD Symptoms - Cough
Description
Change in Cough symptom score (from 0:none to 4:severe) from run-in period
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
Title
Change in COPD Symptoms - Sputum
Description
Change in Sputum symptom score (from 0:none to 4:severe) from run-in period
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
Title
COPD Exacerbations
Description
Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms
Time Frame
Whole treatment period of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Chen, M.D.
Organizational Affiliation
AstraZeneca Pharmaceutical Co., Ltd., Shanghai, China
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Research Site
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Research Site
City
Shen Yang
State/Province
Liaoning
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Research Site
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Research Site
City
Guang Zhou
Country
China
Facility Name
Research Site
City
Kowloon
State/Province
HK
Country
Hong Kong
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Facility Name
Research Site
City
Jakarta
Country
Indonesia
Facility Name
Research Site
City
Solo
Country
Indonesia
Facility Name
Research Site
City
Surabaya
Country
Indonesia
Facility Name
Research Site
City
Wonju-si
State/Province
Gangwon-do
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research Site
City
Jinju-si
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
Country
Korea, Republic of
Facility Name
Research Site
City
Gwangju
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Muang
State/Province
NAN
Country
Thailand
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
Country
Thailand
Facility Name
Research Site
City
Chonburi
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
Country
Thailand
Facility Name
Research Site
City
Nonthaburi
Country
Thailand
Facility Name
Research Site
City
Phitsanulok
Country
Thailand
Facility Name
Research Site
City
Songkhla
Country
Thailand
Facility Name
Research Site
City
Udon Thani
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
26394882
Citation
Lee SD, Xie CM, Yunus F, Itoh Y, Ling X, Yu WC, Kiatboonsri S. Efficacy and tolerability of budesonide/formoterol added to tiotropium compared with tiotropium alone in patients with severe or very severe COPD: A randomized, multicentre study in East Asia. Respirology. 2016 Jan;21(1):119-27. doi: 10.1111/resp.12646. Epub 2015 Sep 23.
Results Reference
derived

Learn more about this trial

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)

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