UMIN-CTR Clinical Trial

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
Email	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
Email	k-fkmt@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Dept of Respiratory Medicine, Allergy and Clinical Immunology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024253