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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001323
Receipt No. 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

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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
Email

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
Email ohbayasi@nn.iij4u.or.jp

Sponsor
Institute JA Gifu Kouseiren Tohno-Kousei Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001611

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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