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
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
1 other identifier
interventional
793
5 countries
31
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2011
31 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
June 27, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
August 27, 2014
CompletedMarch 27, 2015
March 1, 2015
1.9 years
June 27, 2011
June 18, 2014
March 25, 2015
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 (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)
Pre-dose FVC
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)
Post-dose FVC at 5 Minutes
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)
Post-dose FVC at 60 Minutes
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)
- +18 more secondary outcomes
Study Arms (2)
1
OTHERAdd-on treatment
2
OTHERAdd-on treatment
Interventions
Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (31)
Research Site
Beijing, Beijing Municipality, China
Research Site
Guangzhou, Guangdong, China
Research Site
Changsha, Hunan, China
Research Site
Changchun, Jilin, China
Research Site
Shenyang, Liaoning, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Taiyuan, Shanxi, China
Research Site
Guangzhou, China
Research Site
Kowloon, HK, Hong Kong
Research Site
Hong Kong, Hong Kong, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Jakarta, Indonesia
Research Site
Solo, Indonesia
Research Site
Surabaya, Indonesia
Research Site
Wŏnju, Gangwon-do, South Korea
Research Site
Suwon, Gyeonggi-do, South Korea
Research Site
Jinju, Gyeongsangnam-do, South Korea
Research Site
Busan, South Korea
Research Site
Daegu, South Korea
Research Site
Gwangju, South Korea
Research Site
Incheon, South Korea
Research Site
Seoul, South Korea
Research Site
Muang, Changwat Nan, Thailand
Research Site
Nonthaburi, Changwat Nonthaburi, Thailand
Research Site
Chiang Mai, Thailand, Thailand
Research Site
Bangkok, Thailand
Research Site
Chon Buri, Thailand
Research Site
Khon Kaen, Thailand
Research Site
Phitsanulok, Thailand
Research Site
Songkhla, Thailand
Research Site
Udon Thani, Thailand
Related Publications (1)
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.
PMID: 26394882DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nongluk Yimsuan
- Organization
- AstraZeneca
Study Officials
- STUDY CHAIR
Samuel Chen, M.D.
AstraZeneca Pharmaceutical Co., Ltd., Shanghai, China
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
June 27, 2011
First Posted
July 20, 2011
Study Start
July 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
March 27, 2015
Results First Posted
August 27, 2014
Record last verified: 2015-03