UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024622 |
|---|---|
| Receipt number | R000028132 |
| Scientific Title | Optimal inhalation profiles from dry powder inhalers |
| Date of disclosure of the study information | 2016/11/02 |
| Last modified on | 2022/10/21 17:51:48 |
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Basic information
Public title
Optimal inhalation profiles from dry powder inhalers
Acronym
Optimal inhalation profiles from DPI
Scientific Title
Optimal inhalation profiles from dry powder inhalers
Scientific Title:Acronym
Optimal inhalation profiles from DPI
Region
| Japan |
Condition
Condition
bronchial asthma
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine optimal flow patterns from different dry powder inhalers for drug releases.
Basic objectives2
Others
Basic objectives -Others
To investigate whether the patients using dry powder inhalers inhale with optimal flow patterns.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of drug release from the dry powder inhaler in response to different inhaled flow patterns (in vitro study)
Key secondary outcomes
Similarity of patients' inhaled flow patterns from dry powder inhalers to those from in vitro studies (in vivo study)
Base
Study type
Observational
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with bronchial asthma or chronic obstructive pulmonary disease who regularly visit respiratory medicine department of Shonan Fujisawa Tokushukai Hospital, and voluntarily agreed to the study after hearing precise explanation of the study.
Key exclusion criteria
Those who fell into acute exacerbation at the time of study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tetsuri |
| Middle name | |
| Last name | Kondo |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Respiratory Medicie
Zip code
251-0041
Address
1-5-1 Kandai, Tusjido, Fujisawa, Kanagawa
TEL
0466-35-1177
tetsuri@ctmc.jp
Public contact
Name of contact person
| 1st name | Tetsuri |
| Middle name | |
| Last name | Kondo |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Respiratory Medicine
Zip code
251-0041
Address
1-5-1 Kandai, Tusjido, Fujisawa, Kanagawa
TEL
0466-35-1177
Homepage URL
tetsuri@ctmc.jp
Sponsor or person
Institute
Department of Respiratory Medicine,
Shonan Fujisawa Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shonan Fujisawa Tokushukai Hospital
Address
1-5-1 Kandai Tsujido, Fujisawa, Kanagawa
Tel
0463592825
tetsuri@ctmc.jp
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
| 2016 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
https://www.resmedjournal.com/article/S0954-6111(22)00215-3/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.resmedjournal.com/article/S0954-6111(22)00215-3/fulltext
Number of participants that the trial has enrolled
1
Results
Seven asthmatics without recent deterioration and regularly inhaling Turbuhaler or Diskus. Daily inhalation profiles and particle release from either DPI were measured at home for 2 weeks. Inhalation flow profile measured at home is highly reproducible, but tends to be weaker and shorter than that measured in the laboratory. Particle release from Turbuhaler was peak flow-dependent, but that from Diskus was not. The results confirm that rapid inhalations from the start are required when using a DPI.
Results date posted
| 2022 | Year | 10 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 01 | Day |
Baseline Characteristics
One asthmatic patient who was regularly visit Shonan Fujisawa Tokushukai Hospital without recent deterioration and regularly inhaling Turbuhaler.
Participant flow
Masked clinical data was provided to the research group.
Adverse events
none
Outcome measures
Daily inhalation profiles and particle release from Turbuhaler, peak inspiratory flow, inhaled volume
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In both simulation and clinical studies, inhaled flow rate and dispersed drug from dry powder inhaler are recorded. In simulation study, several inhalation patterns are applied. In clinical study subjects inhale from dry powder inhaler as he or her usual way.
Management information
Registered date
| 2016 | Year | 10 | Month | 29 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028132
