UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060887 |
|---|---|
| Receipt number | R000069674 |
| Scientific Title | A questionnaire survey on real-world treatment practices in patients receiving inhaled treprostinil therapy |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/03/10 14:10:27 |
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Basic information
Public title
A questionnaire survey on real-world treatment practices in patients receiving inhaled treprostinil therapy
Acronym
A questionnaire survey on real-world treatment practices in patients receiving inhaled treprostinil therapy
Scientific Title
A questionnaire survey on real-world treatment practices in patients receiving inhaled treprostinil therapy
Scientific Title:Acronym
A questionnaire survey on real-world treatment practices in patients receiving inhaled treprostinil therapy
Region
| Japan |
Condition
Condition
Pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD)
Classification by specialty
| Cardiology | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify real-world treatment practices in patients with PAH or PH-ILD receiving inhaled treprostinil therapy, with a particular focus on treatment satisfaction and treatment-related challenges, as assessed through patient-reported outcomes (PROs).
Basic objectives2
Others
Basic objectives -Others
This study aims to clarify real-world treatment practices in patients with PAH and PH-ILD receiving inhaled treprostinil therapy, with a particular focus on treatment satisfaction and treatment-related challenges, as assessed through patient-reported outcomes (PROs).
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Satisfaction with inhaled treprostinil therapy
2) Changes in symptoms and impact on daily life after initiation of inhaled treprostinil therapy
3) Patient-reported challenges related to inhaled treprostinil therapy
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have provided informed consent.
2) Patients who have been receiving inhaled treprostinil therapy for at least 30 days at the time of survey response.
Key exclusion criteria
1) Patients younger than 18 years of age.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Orido |
Organization
Mochida Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
160-8515
Address
1-7 Yotsuya, Shinjuku-ku, Tokyo, Japan
TEL
03-3225-5138
takashi.orido@mochida.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Orido |
Organization
Mochida Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
160-8515
Address
1-7 Yotsuya, Shinjuku-ku, Tokyo, Japan
TEL
03-3225-5138
Homepage URL
takashi.orido@mochida.co.jp
Sponsor or person
Institute
Mochida Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Takashi Orido
Funding Source
Organization
Mochida Pharmaceutical Co., Ltd.
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
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3, Kichijoji-kitamachi, Musashino-shi, Tokyo, Japan
Tel
03-6779-8166
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2026 | Year | 03 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
A cross-sectional study using a web-based questionnaire survey in patients receiving inhaled treprostinil therapy with the TD-300/J nebulizer provided by Secom Medical System Co., Ltd., who meet the inclusion and exclusion criteria.
Management information
Registered date
| 2026 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069674
