UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015244 |
|---|---|
| Receipt number | R000017719 |
| Scientific Title | Effect of switching from tiotropium to glycopyrronium on pulmonary function in patients with COPD. |
| Date of disclosure of the study information | 2014/09/24 |
| Last modified on | 2016/03/24 13:14:02 |
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Basic information
Public title
Effect of switching from tiotropium to glycopyrronium on pulmonary function in patients with COPD.
Acronym
Effect of switching from tiotropium to glycopyrronium on pulmonary function in patients with COPD.
Scientific Title
Effect of switching from tiotropium to glycopyrronium on pulmonary function in patients with COPD.
Scientific Title:Acronym
Effect of switching from tiotropium to glycopyrronium on pulmonary function in patients with COPD.
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease(COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effect of switching from tiotropium to glycopirronium on pulmonary function in COPD patioents by using spirometry and MostGraph.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FEV1.0
respiratory resistance index(R5,R20,R5-20,X5,Fres)
Key secondary outcomes
CAT score
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching from tiotropium to glycopirronium
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)patients who are diagnosed with GOLD stage 1-4 COPD
2)current or former smokers having at least 10pack-years smoking history
3)patients who have been treated with tiotropium for more than 16weeks before enrollment
4)obtained written informed consent
Key exclusion criteria
1)patients who need systemic corcicosteroidal administration and/or hospitalization for COPD exacerbation within 16 weeks prior to enrollment
2)patients having lower respiratory infection within 16weeks prior to enrollment
3)patients with home oxygen therapy
4)patients with bronchial asthma or chronic respiratory disease such as bronchiectasis,pulmonary fibrosis and pneumoconiosis
5)patients with uncontrolled severe complications
6)patients who seem inadequate for this study by investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohisa Ichikawa |
Organization
KKR Takamatsu hospital
Division name
Respiratory tract medicine
Zip code
Address
4-18, Tenjin-mae, Takamatsu-shi, Kagawa-ken
TEL
087-861-3261
irb@kkr-ta-hp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohisa Ichikawa |
Organization
KKR Takamatsu hospital
Division name
Respiratory tract medicine
Zip code
Address
4-18, Tenjin-mae, Takamatsu-shi, Kagawa-ken
TEL
087-861-3261
Homepage URL
irb@kkr-ta-hp.gr.jp
Sponsor or person
Institute
KKR Takamatsu hospital
Institute
Department
Personal name
Funding Source
Organization
KKR Takamatsu hospital
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
| 2014 | Year | 09 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 24 | Day |
Last modified on
| 2016 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017719
