UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015610 |
|---|---|
| Receipt number | R000018141 |
| Scientific Title | An Open-label Crossover Comparative Investigator-Initiated Trial to Explore Involvement of Peak Inspiratory Flow in Clinical Effects of DPI |
| Date of disclosure of the study information | 2014/11/05 |
| Last modified on | 2015/05/07 14:08:34 |
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Basic information
Public title
An Open-label Crossover Comparative Investigator-Initiated Trial to Explore Involvement of Peak Inspiratory Flow in Clinical Effects of DPI
Acronym
A Comparative Study to Explore Involvement of Peak Inspiratory Flow in Clinical Effects of DPI
Scientific Title
An Open-label Crossover Comparative Investigator-Initiated Trial to Explore Involvement of Peak Inspiratory Flow in Clinical Effects of DPI
Scientific Title:Acronym
A Comparative Study to Explore Involvement of Peak Inspiratory Flow in Clinical Effects of DPI
Region
| Japan |
Condition
Condition
Asthma; Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploring Involvement of Peak Inspiratory Flow in Clinical Efficacy of DPI
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Variations in Impulse Oscillometry Measurements (R5-R20, X5, AX, Fres) from Baseline at Two Hours Post Dosing by Using Advair Diskus or Advair Aerosol and The Relationship with Peak Inspiratory Flow (PIF)
Key secondary outcomes
Efficacy
-Variations in Impulse Oscillometry Measurements from Baseline at Thirty minutes, One Hour, Two Hours Post Inhalation of Advair Diskus
-Variations in Impulse Oscillometry Measurements from Baseline at Thirty minutes, One Hour, Two Hours Post Inhalation of Advair Aerosol
-Comparison Values on Variations in Impulse Oscillometry Measurements from Baseline at Thirty minutes, One Hour, Two Hours Post Inhalation of Advair Diskus or Advair Aerosol
Safety
-Laboratory Values, Adverse Events etc.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
During Treatment Period I (8 days; Visit 2, 3, 4), Impulse Oscillometry measurements are monitored over time (pre-dosing, at 0.5, 1, 2 hours post-dosing) before or after inhalation of Advair Diskus. During Treatment Period II (8 days; Visit 5, 6, 7), Impulse Oscillometry measurements are monitored as in Visit 2, 3, 4 after inhalation of Advair Aerosol.
Interventions/Control_2
During Treatment Period I (8 days; Visit 2, 3, 4), Impulse Oscillometry measurements are monitored over time (pre-dosing, at 0.5, 1, 2 hours post-dosing) before or after inhalation of Advair Aerosol. During Treatment Period II (8 days; Visit 5, 6, 7), Impulse Oscillometry measurements are monitored as in Visit 2, 3, 4 after inhalation of Advair Diskus.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Asthma and/or COPD outpatients with age more than 60 years irrespective of gender
-Asthma and/or COPD outpatients with their PIF values of less than 90 L/min (including at least four patients with their PIF values of less than 60 L/min)
-Patients who are prescribed Advair Diskus over the past four weeks in fixed doses
Key exclusion criteria
-Patients who use steroidal anti-inflammatory drugs
-Patients who has developed respiratory infection in recent 6 weeks
-Patients who are manifested by clinically abnormal laboratory values
-Patients who are judged to be inappropriate as a subject by the clinical research director or the clinical research member
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fukushima, Yasushi |
Organization
Medical Corporation Fukuwakai Fukuwa clinic
Division name
Internal Medicine
Zip code
Address
3-3-11 Nihonbashi, Chuo-ku, Tokyo
TEL
03-6262-3751
yasushi.fukushima.cp@clinipro.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Abe, Kenji |
Organization
Medical Corporation Fukuwakai Fukuwa clinic
Division name
Statistics
Zip code
Address
3-3-11 Nihonbashi, Chuo-ku, Tokyo
TEL
03-3243-0139
Homepage URL
kenji.abe.cp@clinipro.co.jp
Sponsor or person
Institute
Medical Corporation Fukuwakai Fukuwa clinic
Institute
Department
Personal name
Funding Source
Organization
NiPPharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
THE DIVISION OF RESPIRATORY AND ALLERGY, DEPARTMENT OF INTERNAL MEDICINE
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
医療法人社団福和会 福和クリニック/Medical Corporation Fukuwakai Fukuwa clinic
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 05 | 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
IOS data (R5, R20, R5-R20, X5, AX and Fres) showed a tendency which pMDI is more effective than dry powder inhaler in subjects with poor lung function. These data were well accorded with comments of the subjects.
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 | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 29 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 05 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 05 | Day |
Last modified on
| 2015 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018141
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
