UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001323 |
|---|---|
| Receipt number | R000001611 |
| Scientific Title | Open-label cross-over study to evaluate the amount of residual inhaled corticosteroid (hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and fluticasone propionate dry powder inhaler (FP-DPI)) in the mouths of elderly asthmatic patients after each inhalation |
| Date of disclosure of the study information | 2008/08/25 |
| Last modified on | 2010/03/19 02:26:27 |
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Basic information
Public title
Open-label cross-over study to evaluate the amount of residual inhaled corticosteroid (hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and fluticasone propionate dry powder inhaler (FP-DPI)) in the mouths of elderly asthmatic patients after each inhalation
Acronym
The evaluation of the amount of residual inhaled corticosteroid (HFA-BDP and FP-DPI) in the mouths of elderly asthmatic patients after each inhalation.
Scientific Title
Open-label cross-over study to evaluate the amount of residual inhaled corticosteroid (hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and fluticasone propionate dry powder inhaler (FP-DPI)) in the mouths of elderly asthmatic patients after each inhalation
Scientific Title:Acronym
The evaluation of the amount of residual inhaled corticosteroid (HFA-BDP and FP-DPI) in the mouths of elderly asthmatic patients after each inhalation.
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to quantify the residual amount of inhaled corticosteroids (HFA-BDP and FP-DPI) in the mouths of elderly asthmatic patients with dentures after each inhalation, to evaluate the relationship between residual corticosteroids and peak inspiratory flow, and to rationalize the appropriate time for gargling.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the amount of residual inhaled corticosteroids in gargled fluids,
peak inspiratory flow,
Key secondary outcomes
pharyngeal culture for candida, and patient questionnaires
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-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
After evaluating the outcome of HFA-BDP administration, switch to FP-DPI in an equivalent dose. 4 weeks after the switch evaluate its outcome in same way as HFA-BDP.
Interventions/Control_2
After evaluating the outcome of FP-DPI administration, switch to HFA-BDP in an equivalent dose. 4 weeks after the switch evaluate its outcome in same way as FP-DPI.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Asthmatic patients who use HFA-BDP or FP-DPI for more than 3 months with good adhererance.
2. Well-controlled asthma,
3. Non-smoker or ex-smoker more than 1 year after smoking cessation
Key exclusion criteria
1)any hypersensitivity history for steroids, 2)under treatment with oral steroids, 3)under desensitization or non-specific therapy which is newly initiated within 6 months before this study, 4)other coexisting chronic respiratory diseases except for chronic obstructive pulmonary disease (COPD), 5)severe hepatic or renal disease, heart failure, hematologic diseases, or other severe co-morbid disease, 6)under treatment for chronic respiratory infectious diseases, 7)expectation of poor drug compliance, 8)Inappropriate patients from the doctor's viewpoint
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
JA Gifu Kouseiren Tohno-Kousei Hospital
Division name
Dept. of Allergy and Respiratory Medicine
Zip code
Address
76-1, Toki-Cho, Mizunami City 509-6101, Gifu, Japan
TEL
0572-68-4111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
JA Gifu Kouseiren Tohno-Kousei Hospital
Division name
Dept. of Allergy and Respiratory Medicine
Zip code
Address
76-1, Toki-Cho, Mizunami City 509-6101, Gifu, Japan
TEL
0572-68-4111
Homepage URL
ohbayasi@nn.iij4u.or.jp
Sponsor or person
Institute
JA Gifu Kouseiren Tohno-Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Allergy Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2008 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 19 | Day |
Last modified on
| 2010 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001611
