UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010352 |
|---|---|
| Receipt number | R000012094 |
| Scientific Title | Study for effects of tiotropium on smokers and non-smokers with bronchial asthma |
| Date of disclosure of the study information | 2013/03/29 |
| Last modified on | 2018/03/09 13:00:22 |
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Basic information
Public title
Study for effects of tiotropium on smokers and non-smokers with bronchial asthma
Acronym
Tiotropium on smokers and non-smokers with asthma
Scientific Title
Study for effects of tiotropium on smokers and non-smokers with bronchial asthma
Scientific Title:Acronym
Tiotropium on smokers and non-smokers with asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of tiotropium on lung function in smokers and non-smokers with bronchial asthma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Lung function tests (FVC, FEV1, PEFR, V50, V25) before and 1 hour, 3 hours and 24 hours after single inhalation of tiotropium
Key secondary outcomes
Blood pressure, heart rate and SpO2 before and 1 hour, 3hours and 24 hours after single inhala tion of tiotropium
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1) single inhalation of tiotorpium
2) wash out period (3 to 5 weeks)
3) single inhalation of placebo
Interventions/Control_2
1) single inhalation of placebo
2) wash out period (3 to 5 weeks)
3) single inhalation of tiotorpium
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) subjects diagnosed with bronchial asthma
2) subjects treated with high dose inhaled corticosteroid
3) subjects who currently smoke 5 cigarettes per day with smoking history over 5 pack-years, or subjects with no smoking history
Key exclusion criteria
1) subjects treated with oral corticosteroid
2) subjects treated with inhaled of oral anticholinergics
3) short acting beta2 agonists use within 6hours before visits
4) low attenuation area in lung fields on chest HTCT
5) decreased diffusion capasity in lung function tests
6) narrow angle glaucoma
7) benign prostate hypertrophy
8) heart failure, atrial fibrillation or premature beats
9) active infection of respiratory tract or history of pulmonary tuberculosis
10) history of lung surgery
11) allergy to oral or inhaled anticholinergics
12) difficult to perform pulmonary function tests
13) pregnancy or breast-feeding
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Yoshida |
Organization
Fukuoka National Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
TEL
092-565-5534
myoshida@mfukuoka2.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Yoshida |
Organization
Fukuoka National Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
TEL
092-565-5534
Homepage URL
http://www.fukuoka-nh.jp
myoshida@mfukuoka2.hosp.go.jp
Sponsor or person
Institute
Fukuoka National Hospital
Institute
Department
Personal name
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
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
国立病院機構福岡病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 07 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 07 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 29 | Day |
Last modified on
| 2018 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012094
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| Registered date | File name |
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| Registered date | File name |
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