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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015610
Receipt No. 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

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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
Email 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
Email kenji.abe.cp@clinipro.co.jp

Sponsor
Institute Medical Corporation Fukuwakai Fukuwa clinic
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018141

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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