search
Back to results

Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients (SECURE2)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Drug: Budesonide/formoterol (Symbicort Turbuhaler
Drug: ipratropium (AtroventTM)
theophylline SR
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
  • 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

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)

ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)

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) to baseline
Post-dose FVC at 5 Minutes
Ratio of post-dose FVC at 5 minutes to baseline
Post-dose FVC at 60 Minutes
Ratio of post-dose FVC at 60 minutes to baseline
Pre-dose IC
Ratio of pre-dose IC (Inspiratory Capacity) to baseline
Post-dose IC at 60 Minutes
Ratio of post-dose IC at 60 minutes to baseline
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 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 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 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 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
COPD Symptoms - Cough
Change in cough symptom score (from 0 (none) to 4 (almost constant)) from run-in period
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
Use of Reliever Medication During Night in the Last Week on Treatment
Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period
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 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 day from run-in to the whole treatment period

Full Information

First Posted
August 8, 2011
Last Updated
June 28, 2019
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT01415518
Brief Title
Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
Acronym
SECURE2
Official Title
Efficacy and Tolerability Study of Symbicort Turbuhaler(160/4.5µg/Inhalation,2inhalations Twice Daily) Added to Atrovent (20µg/Inhalation, 2 Inhalations 4 Times Daily)+Theophylline SR(0.1g/Tablet,1 Tablet p.o. Twice Daily) Compared With Atrovent+Theophylline SR in Severe COPD Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2011 (Actual)
Primary Completion Date
December 1, 2012 (Actual)
Study Completion Date
December 1, 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.
Detailed Description
Efficacy and tolerability study of Symbicort Turbuhaler (160/4.5µg/inhalation,2inhalations twice daily) added to Atrovent (20µg/inhalation, 2 inhalations 4 times daily) + theophylline SR(0.1g/tablet, 1 tablet p.o. twice daily) compared with Atrovent + theophylline SR in severe COPD patients.

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
581 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
Arm Title
2
Arm Type
Other
Arm Description
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
Intervention Type
Drug
Intervention Name(s)
Drug: Budesonide/formoterol (Symbicort Turbuhaler
Intervention Description
budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)
Intervention Type
Drug
Intervention Name(s)
Drug: ipratropium (AtroventTM)
Intervention Description
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)
Intervention Type
Drug
Intervention Name(s)
theophylline SR
Intervention Description
theophylline SR (0.1g/tablet, 1 tablet p.o. twice 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 (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)
Title
Pre-dose FVC
Description
Ratio of pre-dose FVC (Forced Vital Capacity) to baseline
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)
Title
Post-dose FVC at 5 Minutes
Description
Ratio of post-dose FVC at 5 minutes to baseline
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)
Title
Post-dose FVC at 60 Minutes
Description
Ratio of post-dose FVC at 60 minutes to baseline
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)
Title
Pre-dose IC
Description
Ratio of pre-dose IC (Inspiratory Capacity) to baseline
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)
Title
Post-dose IC at 60 Minutes
Description
Ratio of post-dose IC at 60 minutes to baseline
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)
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
Title
Pre-dose PEF in First Week of Treatment
Description
Change in pre-dose morning PEF 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 measurments 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 (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
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 measurments 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 (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 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
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 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 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 (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 (12 weeks)
Title
COPD Symptoms - Cough
Description
Change in cough symptom score (from 0 (none) to 4 (almost constant)) 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 (12 weeks)
Title
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 (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 (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 day from run-in 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 night in the last week on treatment
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 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 day from run-in 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 night in the whole treatment period (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 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
Organizational Affiliation
AstraZeneca Singapore Pte Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Research Site
City
Foshan
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Zhongshan
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Haikou
State/Province
Hainan
Country
China
Facility Name
Research Site
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Research Site
City
Tangshan
State/Province
Hebei
Country
China
Facility Name
Research Site
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Research Site
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Research Site
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Research Site
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Research Site
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Research Site
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Research Site
City
Chengdu
Country
China
Facility Name
Research Site
City
Chongqin
Country
China
Facility Name
Research Site
City
Da Lian
Country
China
Facility Name
Research Site
City
Ha'er BING
Country
China
Facility Name
Research Site
City
Huhehaote
Country
China

12. IPD Sharing Statement

Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D589BL00022&amp;attachmentIdentifier=2a7ff667-339c-456d-8acc-8e6f547b9c3d&amp;fileName=D589BL00022_Clinical_Study_Protocol_REDACTED.pdf&amp;versionIdentifier=
Description
Clinical Study Protocol
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D589BL00022&amp;attachmentIdentifier=816840bb-da84-40c7-b174-fa5951b2c915&amp;fileName=D589BL00022_SECURE2_Synopsis_1_0_20131126_v2.0001-v4.pdf&amp;versionIdentifier=
Description
CSR Synopsis

Learn more about this trial

Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

We'll reach out to this number within 24 hrs