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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001177
Receipt No. R000001441
Scientific Title Open-label, single-center, randomized and parallel-group study to exmamine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.
Date of disclosure of the study information 2008/06/06
Last modified on 2012/06/07

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Basic information
Public title Open-label, single-center, randomized and parallel-group study to exmamine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.
Acronym Study to examine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.
Scientific Title Open-label, single-center, randomized and parallel-group study to exmamine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.
Scientific Title:Acronym Study to examine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of tulobuterol transdermal therapeutic system(TTS) and that of salmeterol dry powder inhaler on large and small airways involvement in bronchial asthma by using impulse oscillometry and exhaled nitric oxide measurements.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Parameters of impulse oscillometry
Key secondary outcomes 1. Indices of pulmonary function
2. Exhaled nitric oxide concentrations
3. degree of dyspnea (using Medical Research Council dyspnea scale)
4. Quality of life (using St. George's Respiratory Questionnaire)
5. ACT(asthma control test)
6. clinical symptoms(such as wheezing)

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 Add tulobuterol transdermal therapeutic system(TTS) 2 mg once daily to the current medication
Interventions/Control_2 Add inhaled salmeterol 50 mcg twice daily to the current medication
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. Mild or moderate asthma
2. Poorly controlled patients who need additional controler medication to the current treatment including inhaled corticosteroid
3. Astmatic patients diagnosed definitely by airway responsiveness test or airway reversibility test
4. Never smokers or ex-smokers of < 10 pack-years who quit smoking for > one year
Key exclusion criteria 1. Patients with concomitant respiratory disease that may interfere with evaluation of outcomes
2. Patients with hypersensitivity to salmeterol or tulobuterol
3. Patients with dermal disease potentially intolerant to transdermal medication
4. Patients with hyperthyroidism or cardiovascular disease which preclude a use of beta-agonist
5. Pregnancy or lactation
6. Patients who are considered inappropriate by physicians in charge
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Niimi
Organization Kyoto University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan.
TEL 075-751-3830
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Inoue
Organization Kyoto University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan.
TEL 075-751-3830
Homepage URL
Email

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kyoto University Graduate 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
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

Other administrative information
Date of disclosure of the study information
2008 Year 06 Month 06 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
2008 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 09 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 05 Day
Last modified on
2012 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001441

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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