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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024622
Receipt No. R000028132
Scientific Title Optimal inhalation profiles from dry powder inhalers
Date of disclosure of the study information 2016/11/02
Last modified on 2016/10/26

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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
Middle name
Last name Tetsuri Kondo
Organization Shonan Fujisawa Tokushukai Hospital
Division name Respiratory Medicie
Zip code
Address 1-5-1 Kandai, Tusjido, Fujisawa, Kanagawa
TEL 0466-35-1177
Email tetsuri@ctmc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuri Kondo
Organization Shonan Fujisawa Tokushukai Hospital
Division name Respiratory Medicine
Zip code
Address 1-5-1 Kandai, Tusjido, Fujisawa, Kanagawa
TEL 0466-35-1177
Homepage URL
Email tetsuri@ctmc.jp

Sponsor
Institute Department of Respiratory Medicine,
Shonan Fujisawa Tokushukai Hospital
Institute
Department

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
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
2016 Year 11 Month 02 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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 05 Day
Last follow-up date
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
2016 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028132

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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