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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009357
Receipt No. R000010991
Scientific Title The efficacy and safety of long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA) in COPD patients with benign prostatic hyperplasia (BPH)
Date of disclosure of the study information 2012/11/19
Last modified on 2014/03/23

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Basic information
Public title The efficacy and safety of long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA) in COPD patients with benign prostatic hyperplasia (BPH)
Acronym The efficacy and safety of LAMA and LABA in COPD with BPH
Scientific Title The efficacy and safety of long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA) in COPD patients with benign prostatic hyperplasia (BPH)
Scientific Title:Acronym The efficacy and safety of LAMA and LABA in COPD with BPH
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease (COPD)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA) in COPD patients with benign prostatic hyperplasia (BPH)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of lower urinary tract functions (IPSS, QOL index, maximum flow rate (Q-max) and average flow rate (Q-ave) in uroflowmetry, postvoid residual urine volume (PVR), bladder voiding efficiency (BVE))
Key secondary outcomes Changes of pulmonary functions (FEV1, FVC, inspiratory capacity (IC))

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 long-acting muscarinic antagonist (LAMA)
Interventions/Control_2 long-acting beta2-agonist (LABA)
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Patients with chronic obstructive pulmonary disease (COPD)
Patients with benign prostatic hyperplasia (BPH)
Patients can use the inhaled therapy
Patients gave written informed consent
Key exclusion criteria History of hyper-sensitivity to long-acting muscarinic antagonist (LAMA), long-acting beta2-agonist (LABA), inhaled corticosteroid (ICS)
Patients with bronchial asthma
Patients during acute exacerbation
Presence of infectious disease, pneumothorax, and severe heart failure
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal medicine
Zip code
Address 1-20-1, Handayama, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Yasui
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal medicine
Zip code
Address 1-20-1, Handayama, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2263
Homepage URL
Email yassy19781119@yahoo.co.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 11 Month 19 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
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 18 Day
Last modified on
2014 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010991

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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