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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000010352
Receipt No. 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

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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
Email 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
Email myoshida@mfukuoka2.hosp.go.jp

Sponsor
Institute Fukuoka National Hospital
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 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012094

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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