UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009857 |
|---|---|
| Receipt number | R000011549 |
| Scientific Title | Effects of a newly bronchodilator for lung hyperinflation and exercise tolerance in patients with mild to moderate stable COPD |
| Date of disclosure of the study information | 2013/01/24 |
| Last modified on | 2014/10/27 22:36:18 |
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Basic information
Public title
Effects of a newly bronchodilator for lung hyperinflation and exercise tolerance in patients with mild to moderate stable COPD
Acronym
Effects of a newly bronchodilator in patients with mild to moderate stable COPD
Scientific Title
Effects of a newly bronchodilator for lung hyperinflation and exercise tolerance in patients with mild to moderate stable COPD
Scientific Title:Acronym
Effects of a newly bronchodilator in patients with mild to moderate stable COPD
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy ofindacaterol and glycopyrronium bromide, this study is planned with lung hyperinflation and excercise tolerance in stable mild to moderate COPD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo-Placebo
Interventions/Control_2
Indacaterol-Placebo
Interventions/Control_3
Glycopyrronium bromide-Placebo
Interventions/Control_4
Indacaterol-Glycopyrronium bromide
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Clinical stable mild to moderate COPD patients with age more than 40 years
2. A post-bronchodilator forced expiratory volume in 1 second (FEV1) /forced vital capacity (FVC) of < 0.7. a post-bronchodilator forced expiratory volume <120% and >50% of the predicted normal value (i.e. stage Ior II)
3. Patients who provided written informed consent
Key exclusion criteria
1.other respiratory disease
2.severe other orgen disease
3.subjects who have been treated with LABA and/or LAMA in 2 weeks
4.subjects who have been shown exacervation.
5.subjects who doctors regarded unsuitable for this trial
6.subjects who had allergy for these drugs.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kinoshita |
Organization
Kurume University School of Medicine
Division name
Department of Medicine, Division of Respiratory, Neurology and Rheumatology
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kinoshita |
Organization
Kurume University School of Medicine
Division name
Department of Medicine, Division of Respiratory, Neurology and Rheumatology
Zip code
Address
TEL
0942-35-3311
Homepage URL
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
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
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
| 2013 | Year | 01 | Month | 24 | 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
| 2013 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | 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
| 2013 | Year | 01 | Month | 24 | Day |
Last modified on
| 2014 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011549
