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)
NCT ID: NCT01397890
Last Updated: 2015-03-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
793 participants
INTERVENTIONAL
2011-07-31
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
NCT00496470
Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients
NCT01917643
Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®
NCT01803555
Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Participants With Asthma
NCT02062463
Bioequivalence Study of Tiotropium Bromide Inhalation Powder
NCT05161156
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Add-on treatment
Budesonide/formoterol (Symbicort® Turbuhaler®)
Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily
Tiotropium (SpirivaTM)
Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily
2
Add-on treatment
Tiotropium (SpirivaTM)
Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Budesonide/formoterol (Symbicort® Turbuhaler®)
Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily
Tiotropium (SpirivaTM)
Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Samuel Chen, M.D.
Role: STUDY_CHAIR
AstraZeneca Pharmaceutical Co., Ltd., Shanghai, China
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D589BL00023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.