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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01415518
First received: August 8, 2011
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Drug: Budesonide/formoterol (Symbicort Turbuhaler
Drug: Drug: ipratropium (AtroventTM)
Drug: theophylline SR
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: 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.

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 Expiratory 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 (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 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) to baseline

  • 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

  • Post-dose FVC 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 FVC at 60 minutes to baseline

  • Pre-dose IC [ 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 IC (Inspiratory Capacity) to baseline

  • 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

  • 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 ] [ 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 measurments measured before inhalation of study drug in the first week of treatment ] [ Designated as safety issue: No ]
    Change in pre-dose morning PEF 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 (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 ] [ 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 measurments 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 (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 ] [ Designated as safety issue: No ]
    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 [ 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 ]
    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 [ 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) ] [ Designated as safety issue: No ]
    Change in the number of inhalations of reliever medication during day from run-in 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 (12 weeks) ] [ Designated as safety issue: No ]
    Change in breathing symptom score (from 0 (none) to 4 (severe)) from run-in period

  • 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 (12 weeks) ] [ Designated as safety issue: No ]
    Change in cough symptom score (from 0 (none) to 4 (almost constant)) from run-in period

  • 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 (12 weeks) ] [ Designated as safety issue: No ]
    Change in sputum symptom score (from 0 (none) to 4 (severe)) from run-in period

  • COPD Exacerbations [ Time Frame: Whole treatment period (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

  • 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 night in the last week on treatment ] [ Designated as safety issue: No ]
    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 [ 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 ]
    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 [ 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) ] [ Designated as safety issue: No ]
    Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period


Enrollment: 581
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
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)
Drug: Drug: Budesonide/formoterol (Symbicort Turbuhaler
budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)
Drug: Drug: ipratropium (AtroventTM)
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)
Drug: theophylline SR
theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
2
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
Drug: Drug: ipratropium (AtroventTM)
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)
Drug: theophylline SR
theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)

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.

  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
  • 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: NCT01415518

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Foshan, Guangdong, China
Research Site
Guangzhou, Guangdong, China
Research Site
Zhongshan, Guangdong, China
China, Hainan
Research Site
Haikou, Hainan, China
China, Hebei
Research Site
Shijiazhuang, Hebei, China
Research Site
Tangshan, Hebei, China
China, Henan
Research Site
Zhengzhou, Henan, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Jilin
Research Site
Changchun, Jilin, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China, Shandong
Research Site
Qingdao, Shandong, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Tianjin
Research Site
Tianjin, Tianjin, China
China
Research Site
Chengdu, China
Research Site
Chongqin, China
Research Site
Da Lian, China
Research Site
Ha'er Bing, China
Research Site
Huhehaote, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Samuel Chen AstraZeneca Singapore Pte Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01415518     History of Changes
Other Study ID Numbers: D589BL00022
Study First Received: August 8, 2011
Results First Received: November 25, 2013
Last Updated: August 11, 2014
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 22, 2014