UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020028 |
|---|---|
| Receipt number | R000023131 |
| Scientific Title | Peak cough flow and sputum substance P concentration in patients with neurodegenerative disease |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2022/04/23 11:11:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Peak cough flow and sputum substance P concentration in patients with neurodegenerative disease
Acronym
PCF and sputum SP in neurodegenerative disease patients
Scientific Title
Peak cough flow and sputum substance P concentration in patients with neurodegenerative disease
Scientific Title:Acronym
PCF and sputum SP in neurodegenerative disease patients
Region
| Japan |
Condition
Condition
neurodegenerative disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Airway protective mechanisms such as swallowing and cough may play an important role in patients with neurodegenerative disease to avoid aspiration pneumonia. Angiotensin-converting enzyme inhibitor (ACE-I) and anti Parkinson's disease drug induced cough is believed to be related to the accumulation of bradykinin, substance P and prostaglandins. We evaluated forced vital capacity (%FVC) and peak cough expiratory flow (PCEF) and sputum substance P concentration, and examined efficacy of ACE-I and anti PD drug.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Forced vital capacity, substance P
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
anti-PD drug, ACE-I
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who fulfilled the diagnostic criteria of each neurodegenerative diseases
Key exclusion criteria
patients who showed cognitive impairment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Kano |
Organization
Toho University School of medicine
Division name
Dept of Neurology
Zip code
1438541
Address
6-11-1 Omorinishi Ota-ku Tokyo, Japan
TEL
0337624151
osamukano2@gmail.com
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Kano |
Organization
Toho University School of medicine
Division name
Dept of Neurology
Zip code
1438541
Address
6-11-1 Omorinishi Ota-ku
TEL
0337624151
Homepage URL
osamukano@aol.com
Sponsor or person
Institute
Toho University
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
Toho University
Address
6-11-1 Omorinishi Ota-ku
Tel
0337624151
osamu.kano@med.toho-u.ac.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
| 2015 | Year | 12 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023131
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
