UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013314 |
|---|---|
| Receipt number | R000015329 |
| Scientific Title | Adherence of inhalation drugs in asthma and chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2014/03/04 |
| Last modified on | 2016/01/18 16:42:54 |
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Basic information
Public title
Adherence of inhalation drugs in asthma and chronic obstructive pulmonary disease
Acronym
Adherence of inhalation drugs in asthma and chronic obstructive pulmonary disease
Scientific Title
Adherence of inhalation drugs in asthma and chronic obstructive pulmonary disease
Scientific Title:Acronym
Adherence of inhalation drugs in asthma and chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
Bronchial asthma
Chronic obstructive pulmonary disease(COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate adherence between inhalation and oral.
Basic objectives2
Others
Basic objectives -Others
To explore factors which decrease the adherence.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The present state of adherence by questionnaire.
Key secondary outcomes
1. To compare adherence between asthma and COPD
2. To evaluate adherence among device
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1Asthma patients with age more than 20
years and COPD patients are more than
40 years
2Patients diagnosed with asthma or COPD
and have been prescribed with inhaler
3Patients who provided written informed
consent
Key exclusion criteria
1Other respiratory disease
2Patients with neurophychiatric disorder
3Patients with cerebrovascular disorder
4Patients who inhalation technique is
difficult
5Patients who had allergy for these drugs
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomotaka Kawayama |
Organization
Kurume University School of Medicine
Division name
Department of Medicine, Division of Respiratory, Neurology and Rheumatology
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942-31-7560
kawayama_tomotaka@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kinoshita |
Organization
Kurume University School of Medicine
Division name
Department of Medicine, Division of Respiratory, Neurology and Rheumatology
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942-31-7560
Homepage URL
tkino@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 04 | 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 | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Adherence of inhaler by questionnaire.
Cross-sectional method (one point)
Management information
Registered date
| 2014 | Year | 03 | Month | 03 | Day |
Last modified on
| 2016 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015329
