UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026496 |
|---|---|
| Receipt number | R000030400 |
| Scientific Title | Efficacy and safety of long-acting beta-2 agonist and long-acting muscarinic antagonist combinations in patients with chronic obstructive pulmonary disease: meta-analysis of phase 3 randomized trials |
| Date of disclosure of the study information | 2017/03/13 |
| Last modified on | 2017/03/10 11:34:16 |
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Basic information
Public title
Efficacy and safety of long-acting beta-2 agonist and long-acting muscarinic antagonist combinations in patients with chronic obstructive pulmonary disease: meta-analysis of phase 3 randomized trials
Acronym
Long-acting beta-2 agonist and long-acting muscarinic antagonist combinations in COPD patients
Scientific Title
Efficacy and safety of long-acting beta-2 agonist and long-acting muscarinic antagonist combinations in patients with chronic obstructive pulmonary disease: meta-analysis of phase 3 randomized trials
Scientific Title:Acronym
Long-acting beta-2 agonist and long-acting muscarinic antagonist combinations in COPD patients
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the overall efficacy and safety of long-acting beta-2 agonist (LABA) and long-acting muscarinic antagonist (LAMA) combination therapies (LABA/LAMA) versus monotherapies or placebo in chronic obstructive pulmonary disease (COPD) patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in forced expiratory volume in 1 second (FEV1.0) from baseline
Key secondary outcomes
St. George's respiratory questionnaire scores, serious adverse events, all cardiovascular events, major cardiovascular events, non-major cardiovascular events, COPD worsening, nasopharyngitis, and all adverse events
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with chronic obstructive pulmonary disease
Key exclusion criteria
patients with bronchial asthma, or with severe cardiovascular disease
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Ando |
Organization
Showa University
Division name
Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
Address
1-5-8, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL
+81-3-3784-8532
koichi-a@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Ando |
Organization
Showa University
Division name
Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
Address
Hatanodai, 1-5-8, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL
+81-3-3784-8532
Homepage URL
koichi-a@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The overall efficacy and safety of LABA/LAMA versus LABA, LAMA, or placebo in patients with COPD were assessed by meta-analysis of phase 3 trials. We identified phase 3 LABA/LAMA studies by searching PubMed, Scopus, and the Cochrane library database. Primary efficacy outcomes included changes in forced expiratory volume in 1 second (FEV1.0) from baseline. Eleven articles including thirteen randomized controlled trials of LABA/LAMA met the criteria for inclusion in the study. Pulmonary function and health-related quality of life were significantly higher for LABA/LAMA, and the risk of SAEs or MACEs did not significantly increase. These results provide information regarding the overall efficacy and safety of LABA/LAMA in patients with COPD.
Management information
Registered date
| 2017 | Year | 03 | Month | 10 | Day |
Last modified on
| 2017 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030400
