UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013318 |
|---|---|
| Receipt number | R000015537 |
| Scientific Title | Efficacy of formoterol inhalation in patients with chronic obstructive pulmonary disease: investigation of the effects on the central and peripheral airways starting from immediately after inhalation |
| Date of disclosure of the study information | 2014/03/07 |
| Last modified on | 2014/10/06 09:39:58 |
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Basic information
Public title
Efficacy of formoterol inhalation in patients with chronic obstructive pulmonary disease: investigation of the effects on the central and peripheral airways starting from immediately after inhalation
Acronym
Bronchodilator effects on the central and peripheral airways of formoterol inhalation treatment (BENEFIT Study)
Scientific Title
Efficacy of formoterol inhalation in patients with chronic obstructive pulmonary disease: investigation of the effects on the central and peripheral airways starting from immediately after inhalation
Scientific Title:Acronym
Bronchodilator effects on the central and peripheral airways of formoterol inhalation treatment (BENEFIT Study)
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the short-time bronchodilating effects of formoterol inhalation in Japanese COPD patients by time-course measurement of spirometry and MostGraph.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the FEV1-time curve from 0 (before drug inhalation) to 120 minutes after inhalation (AUC)
Key secondary outcomes
(1) Changes in spirometry parameters
(2) Changes in MostGraph parameters
(3) Respiratory function questionnaire
(4) Safety
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
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
9 mcg of formoterol is inhaled once daily.
Interventions/Control_2
18 mcg of tiotropium is inhaled once daily.
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) Smoking history 10 pack-year or more
2) COPD stage II or III (according to the 4th edition of Guidelines for the diagnosis and treatment of COPD published by the Japanese Respiratory Society)
Key exclusion criteria
1) Patients with asthma
2) Treatment with oral corticosteroid
3) Insufficient inspiratory flow rate
4) Hospitalization within last 1 month
5) Emergency or unsheduled department visit for COPD within last 1 month
6) Respiratory infection within last 2 weeks
7) Cardiovascular disease
8) Lactating, pregnancy, or suspected pregnancy
9) Other unsuitable patients judged by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
Tohno Chuo Clinic
Division name
Tohno Chuo Clinic
Zip code
Address
1-14-1, Matsugasecho, Mizunami-shi, Gifu, 509-6134, Japan
TEL
0572-67-1118
ohbayasi@nn.iij4u.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
Tohno Chuo Clinic
Division name
Tohno Chuo Clinic
Zip code
Address
1-14-1, Matsugase-cho, Mizunami-shi, Gifu, Japan
TEL
0572-67-1118
Homepage URL
ohbayasi@nn.iij4u.or.jp
Sponsor or person
Institute
General incorporated association, Academy of Inhalation Methods (AIMs)
Institute
Department
Personal name
Funding Source
Organization
General incorporated association, Academy of Inhalation Methods (AIMs)
Organization
Division
Category of Funding Organization
Non profit foundation
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
東濃中央クリニック
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 07 | 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
| 2014 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 03 | Day |
Last modified on
| 2014 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015537
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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