UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009077 |
|---|---|
| Receipt number | R000010478 |
| Scientific Title | Comparison of the effect of tiotropium monotherapy versus tiotropium and indacaterol combination therapy in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2012/10/10 |
| Last modified on | 2023/04/19 14:47:46 |
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Basic information
Public title
Comparison of the effect of tiotropium monotherapy versus tiotropium and indacaterol combination therapy in patients with chronic obstructive pulmonary disease
Acronym
Comparison of the effect of tiotropium monotherapy versus tiotropium and indacaterol combination therapy in patients with chronic obstructive pulmonary disease
Scientific Title
Comparison of the effect of tiotropium monotherapy versus tiotropium and indacaterol combination therapy in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Comparison of the effect of tiotropium monotherapy versus tiotropium and indacaterol combination therapy in patients with chronic obstructive pulmonary disease
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 the efficacy and the safety of the combined therapy compared with the mono therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1(The add-on effects of the combined therapy on FEV1 in patients with COPD.
2) CAT (COPD Assessment Test) score and modified medical research council score
Key secondary outcomes
Airway resistance (R5, R20, R5-R20)
Change of HADS (Hospital Anxiety and Depression Scale)
Change of Rint (Interrupter airway resistance)
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
5 microgram once daily tiotropium
Interventions/Control_2
5 microgram once daily tiotropium and 150 microgram once daily indacaterol
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. Patient who is outpatient of Chiba-Hokusoh Hospital is able to read and understand the Informed Consent Form and he/she will sign the Informed Consent.
2. COPD patient, over 40 years, meets all of the following inclusion criteria.
Current or former smokers.
FEV1/FVC level is within 70% after 15 minutes used the bate 2 agonist on respiratory function test .
Key exclusion criteria
1. Patient who has an anamnesis of hypersensitivity to the medicine used by this research .
2. Patient of the symptom that bronchial asthma is main.
3. Patient who has already used LABA other than indacaterol. The patient who is using other LABA presupposes that participation is possible, when the wash out period for four weeks or more is prepared before a start.
4. A glaucomatous patient
5. Patient with the urination trouble by prostatic hypertrophy.
6. Patient who was considered ineligible by the investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Chiba-Hokusoh Hospital, Nippon Medical School
Division name
Department of Respiratory Medicinev
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba, 270-1694, Japan
TEL
0476-99-1961
yosuke-t@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Chiba-Hokusoh Hospital, Nippon Medical School
Division name
Department of Respiratory Medicine
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba, 270-1694, Japan
TEL
0476-99-1961
Homepage URL
yosuke-t@nms.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
the Ethics Committee of Nippon Medical School
Address
Department of Respiratory Medicine, Nippon Medical School, Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba 270-1694, Japan.
Tel
0476-99-1111
araraki@nms.ac.jp
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
日本医科大学千葉北総病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010478
