UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021064 |
|---|---|
| Receipt number | R000024253 |
| Scientific Title | Efficacy of Tiotropium bromide (Spiriva 2.5 microgram Respimat 60 puffs) for chronic asthmatic cough refractory to intensive therapies |
| Date of disclosure of the study information | 2016/02/24 |
| Last modified on | 2020/07/09 00:05:58 |
* 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
Efficacy of Tiotropium bromide (Spiriva 2.5 microgram Respimat 60 puffs) for chronic asthmatic cough refractory to intensive therapies
Acronym
Efficacy of Tiotropium bromide (Spiriva 2.5 microgram Respimat 60 puffs) for chronic asthmatic cough refractory to intensive therapies
Scientific Title
Efficacy of Tiotropium bromide (Spiriva 2.5 microgram Respimat 60 puffs) for chronic asthmatic cough refractory to intensive therapies
Scientific Title:Acronym
Efficacy of Tiotropium bromide (Spiriva 2.5 microgram Respimat 60 puffs) for chronic asthmatic cough refractory to intensive therapies
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Tiotropium bromide (Spiriva 2.5 microgram Respimat 60 puffs) for chronic asthmatic cough refractory to intensive therapies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the changes of the degree of cough severity and the cough-specific quality of life before and 4 weeks after the treatment intervention, with a use of Cough Visual Analogue Scale and Leicester Cough Questionnaire, respectively
Key secondary outcomes
To evaluate the changes of capsaicin cough reflex sensitivity and several biomarkers before and 4 weeks after the treatment intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Add on tiotropium bromide(5 microgram/day).
Interventions/Control_2
Add on theophylline (400 mg/day).
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic asthmatic cough lasting for 8 weeks or more despite adequate treatments including inhaled corticosteroids and long-acting adrenergic bronchodilator
Key exclusion criteria
If patients meet the following criteria, they are excluded.
Patients who
have other respiratory disease such as tuberculosis or lung cancer.
currently smoke, had smoking history with 10 pack-years or more, or had quitted smoking within 6 months prior to the enrollment.
have already taken anti-cholinergic agents or xanthin.
have already taken some medicines with anti-cholinergic effects
have allergy for anti-cholinergic agents or xanthin.
have benign prostatic hypertrophy with dysuria.
have closed-angle glaucoma.
are during pregnancy or lactaion, or have possibility of pregnancy.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University
Division name
Dept of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8216
kaney32@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Fukumitsu |
Organization
Nagoya City University
Division name
Dept of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8216
Homepage URL
k-fkmt@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Dept of Respiratory Medicine, Allergy and Clinical Immunology
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Dept of Respiratory Medicine, Allergy and Clinical Immunology
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
Nagoya City University
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
| 2016 | Year | 02 | Month | 24 | 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
58
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The results have not analysed yet.
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
| 2016 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 16 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024253
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
