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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026496
Receipt No. 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

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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
Email 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
Email koichi-a@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030400

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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