- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03197818
Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)
March 30, 2021 updated by: Chiesi Farmaceutici S.p.A.
A 24-week, Double Blind, Double Dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group,Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide Administered Via pMDI (CHF 5993) Versus the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort® Turbuhaler®) in Patients With Chronic Obstructive Pulmonary Disease
The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well as to assess its safety.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
990
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100000
- Chiesi clinical Trial Site 156031
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Beijing, Beijing, China, 100020
- Chiesi Clinical Trial Site 156026
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Beijing, Beijing, China, 100029
- Chiesi clinical Trial Site 156017
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Beijing, Beijing, China, 100144
- Chiesi Clinical Trial Site 156012
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Chongqing
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Chongqing, Chongqing, China, 400000
- Chiesi Clinical Trial Site 156045
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Fujian
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Fuzhou, Fujian, China, 350005
- Chiesi Clinical Trial Site 156002
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Guangdong
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Foshan, Guangdong, China, 528000
- Chiesi clinical Trial Site 156024
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Guangzhou, Guangdong, China, 510000
- Chiesi Clinical Trial Site 156048
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Guangzhou, Guangdong, China, 510080
- Chiesi Clinical Trial Site 156013
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Guanzhou, Guangdong, China, 510120
- The First Affiliated Hospital of Guangzhou Medical University site 156001
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Zhanjiang, Guangdong, China, 524000
- Chiesi Clinical Trial Site 156008
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Guangxi
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Nanning, Guangxi, China, 530021
- Chiesi Clinical Trial site 156003
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Hainan
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Haikou, Hainan, China, 570100
- Chiesi clinical Trial Site 156020
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Hebei
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Shijiangzhuang, Hebei, China, 050000
- Chiesi Clinical Trial Site 156044
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Hunan
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Changsha, Hunan, China, 410000
- Chiesi Clinical Trial Site 156040
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Changsha, Hunan, China, 410011
- Chiesi Clinical Trial Site 156040
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Inner Mongolia
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Baotou, Inner Mongolia, China, 014000
- Chiesi Clinical Trial Site 156043
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Baotou, Inner Mongolia, China, 014010
- Chiesi Clinical Trial Site 156015
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Jiangsu
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Huai'an, Jiangsu, China, 223300
- Chiesi Clinical Trial Site 156004
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Jiangyin, Jiangsu, China, 320281
- Chiesi clinical Trial Site 156033
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Nanjing, Jiangsu, China, 210006
- Chiesi clinical Trial Site 156022
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Suzhou, Jiangsu, China, 215000
- Chiesi Clinical Trial Site 156049
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Jiangxi
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Jiujiang, Jiangxi, China, 332000
- Chiesi Clinical Trial Site 156047
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Nanchang, Jiangxi, China, 330000
- Chiesi Clinical Trial Site 156041
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Nanchang, Jiangxi, China, 330006
- Chiesi clinical Trial Site 156028
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Pingxiang, Jiangxi, China, 337000
- Chiesi Clinical Trial Site 156042
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Jilin
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Changchun, Jilin, China, 130000
- Chiesi clinical Trial Site 156023
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Changchun, Jilin, China, 130000
- Chiesi Clinical Trial Site 156036
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Changchun, Jilin, China, 130021
- Chiesi clinical Trial Site 156019
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Liaoning
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Shenyang, Liaoning, China, 110004
- Chiesi Clinical Trial Site 156007
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Ningxia
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YinChuan, Ningxia, China, 750000
- Chiesi clinical Trial Site 156025
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Shanghai
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Shanghai, Shanghai, China, 200025
- Chiesi Clinical Trial Site 156014
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Shanghai, Shanghai, China, 200031
- Chiesi clinical Trial Site 156037
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Shanghai, Shanghai, China, 200072
- Chiesi Clinical Trial Site 156005
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Shanghai, Shanghai, China, 200433
- Chiesi Clinical Trial Site 156006
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Shanghai, Shanghai, China, 200433
- Chiesi Clinical Trial Site 156011
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Shanghai, Shanghai, China, 210009
- Chiesi Clinical Trial Site 156038
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Shanxi
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Taiyuan, Shanxi, China, 030001
- Chiesi Clinical Trial Site 156039
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Sichuan
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Chengdu, Sichuan, China, 610000
- Chiesi clinical Trial Site 156035
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Chengdu, Sichuan, China, 610041
- Chiesi Clinical Trial Site 156010
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Chongqing, Sichuan, China, 400000
- Chiesi clinical Trial Site 156032
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Tianjin
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Tianjin, Tianjin, China, 300052
- Chiesi clinical Trial Site 156034
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Zhejiang
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Hangzhou, Zhejiang, China, 310014
- Chiesi clinical Trial Site 156018
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Linhai, Zhejiang, China, 317000
- Chiesi Clinical Trial Site 156046
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Seoul, Korea, Republic of, 04401
- Chiesi Clinical Trial Site 410011
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Seoul, Korea, Republic of, 2559
- Chiesi Clinical Trial Site 410013
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Seoul, Korea, Republic of, 5030
- Chiesi Clinical Trial Site 410014
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Gang'weondo
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Chuncheon, Gang'weondo, Korea, Republic of, 24289
- Chiesi Clinical Trial Site 410003
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Gyeonggido
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Bucheon, Gyeonggido, Korea, Republic of, 420-717
- Chiesi Clinical Trial Site 410001
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Bucheon-si, Gyeonggido, Korea, Republic of, 14584
- Chiesi Clinical Trial Site 410012
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Goyang-si, Gyeonggido, Korea, Republic of, 10380
- Chiesi Clinical Trial Site 410002
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Jeonrabugdo
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Jeonju, Jeonrabugdo, Korea, Republic of, 54907
- Chiesi Clinical Trial Site 410005
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Seoul Teugbyeols
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Gyeonggi-do, Seoul Teugbyeols, Korea, Republic of, 135-720
- Chiesi Clinical Trial Site 410009
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07345
- Chiesi Clinical Trial Site 410008
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07985
- Chiesi Clinical Trial Site 410007
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 100-032
- Chiesi Clinical Trial Site 410004
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 136-705
- Chiesi Clinical Trial Site 410006
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Ulsan
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Daegu, Ulsan, Korea, Republic of, 705-703
- Chiesi Clinical Trial Site 410010
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Changhua, Taiwan, 500
- Chiesi Clinical Trial Site 158010
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Kaohsiung, Taiwan, 824
- Chiesi Clinical Trial Site 158006
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Taichung, Taiwan
- Chiesi Clinical Trial Site 158008
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Taipei, Taiwan, 11217
- Chiesi Clinical Trial Site 158005
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Taipei, Taiwan, 220
- Chiesi Clinical Trial Site 158011
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Keelung Municipality
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Keelung, Keelung Municipality, Taiwan, 204
- Chiesi Clinical Trial Site 158001
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Penghu
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Kaohsiung, Penghu, Taiwan, 83301
- Chiesi Clinical Trial Site 158004
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Taiwan Province
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Changhua, Taiwan Province, Taiwan, 500
- Chiesi Clinical Trial Site 158010
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Yunlin
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Douliu, Yunlin, Taiwan, 64041
- Chiesi Clinical Trial Site 158003
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or Female adults aged > 40 years with a diagnosis of COPD
- Current smokers or ex-smokers
- A post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 at least 10-15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI
- At least one exacerbation in the 12 months preceding the screening visit
Exclusion Criteria:
- Pregnant or lactating women
- Diagnosis of asthma, history of allergic rhinitis or atopy
- Patients treated for exacerbations in the 4 weeks prior to screening visit
- Patients treated with non-cardioselective ß-blockers in the month preceding the screening visit
- Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as Pro Re Nata
- Patients requiring long term ( at least 12 hours daily) oxygen therapy for chronic hypoxemia
- Known respiratory disorders other than COPD
- Patients who have clinically significant cardiovascular condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CHF 5993 100/6/12.5 µg
Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose (BDP/FF/GB) (Beclometasone dipropionate / Formoterol Fumarate / glycoppyronium Bromide)
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Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose
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Active Comparator: Symbicort Turbuhaler 160/4.5 µg
Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (160µg + 4.5 µg expresses the delivered dose; 200 µg + 6 µg expresses the metered dose) ( BUD/FF) (Budesonide/Formoterol Fumarate)
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Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24
Time Frame: Baseline to Week 24
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Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24
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Baseline to Week 24
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Change from Baseline in 2-hour post-dose FEV1 at week 24
Time Frame: Baseline to Week 24
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Change from Baseline in 2-hour post-dose FEV1 at week 24
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Baseline to Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at week 24
Time Frame: Baseline to Week 24
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Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose
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Baseline to Week 24
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Time to First COPD exacerbation
Time Frame: Baseline to week 24
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Time to First COPD exacerbation
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Baseline to week 24
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Rate of COPD exacerbations
Time Frame: Baseline to week 24
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Rate of COPD exacerbations
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Baseline to week 24
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Change in COPD Assessment Test (CAT)
Time Frame: At all visits (from baseline to Week 24)
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Change in COPD Assessment Test (CAT)
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At all visits (from baseline to Week 24)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events and Adverse Drug reactions
Time Frame: Screening up to week 24
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Adverse Events and Adverse Drug reactions
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Screening up to week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jinping Zheng, The First Affiliated Hospital of Guangzhou Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2016
Primary Completion (Actual)
May 26, 2020
Study Completion (Actual)
May 26, 2020
Study Registration Dates
First Submitted
January 25, 2017
First Submitted That Met QC Criteria
June 22, 2017
First Posted (Actual)
June 23, 2017
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 30, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Formoterol Fumarate
Other Study ID Numbers
- CCD-5993AA1-14
- China (Other Identifier: China: Food and Drug Administration)
- Taiwan (Other Identifier: Taiwan : Food and Drug Administration)
- South Korea (Other Identifier: Ministry of Food and Drugs Safety)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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