UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Koichi Ando
Organization	Showa University
Division name	Division of Respiratory Medicine and Allergology, Department of Medicine
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	Koichi Ando
Organization	Showa University
Division name	Division of Respiratory Medicine and Allergology, Department of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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