Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
SECURE2
1 other identifier
interventional
581
1 country
21
Brief Summary
Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2011
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
August 26, 2014
CompletedJuly 9, 2019
June 1, 2019
1.3 years
August 8, 2011
November 25, 2013
June 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pre-dose FEV1
Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value
Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug
Secondary Outcomes (23)
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
Post-dose FEV1 at 60 Minutes
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)
Pre-dose FVC
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)
Post-dose FVC at 5 Minutes
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)
Post-dose FVC at 60 Minutes
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)
- +18 more secondary outcomes
Study Arms (2)
1
OTHERbudesonide/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)
2
OTHERipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
Interventions
budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (21)
Research Site
Beijing, Beijing Municipality, China
Research Site
Foshan, Guangdong, China
Research Site
Guangzhou, Guangdong, China
Research Site
Zhongshan, Guangdong, China
Research Site
Haikou, Hainan, China
Research Site
Shijiazhuang, Hebei, China
Research Site
Tangshan, Hebei, China
Research Site
Zhengzhou, Henan, China
Research Site
Wuhan, Hubei, China
Research Site
Changsha, Hunan, China
Research Site
Nanjing, Jiangsu, China
Research Site
Changchun, Jilin, China
Research Site
Shenyang, Liaoning, China
Research Site
Qingdao, Shandong, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Tianjin, Tianjin Municipality, China
Research Site
Chengdu, China
Research Site
Chongqin, China
Research Site
Dalian, China
Research Site
Ha'er BING, China
Research Site
Hohhot, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Goran Eckerwall
- Organization
- AstraZeneca
Study Officials
- STUDY CHAIR
Samuel Chen
AstraZeneca Singapore Pte Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2011
First Posted
August 12, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 9, 2019
Results First Posted
August 26, 2014
Record last verified: 2019-06