臨床研究等提出・公開システム

Date of registration	Dec. 13, 2022
Last modified on	July. 27, 2026
Trial ID	jRCT1041220103

Scientific Title	Reference range setting test for the number of induced coughs by inhalation of provocholine using the Astograph method
Public Title	Setting the reference range of the provocholine cough test by the Astograph method

Contact for Scientific Queries	Name	Kenta Yamamura
	Affiliation	Kanazawa University Hospital
	Address	13-1, Takara-machi, Kanazawa, Ishikawa, 920-8641
	Telephone	+81-76-265-2756
	E-mail	kenta-yamamura@staff.kanazawa-u.ac.jp
Contact for Public Queries	Name	Kenta Yamamura
	Affiliation	Kanazawa University Hospital
	Address	13-1, Takara-machi, Kanazawa, Ishikawa, 920-8641
	Telephone	+81-76-265-2756
	E-mail	kenta-yamamura@staff.kanazawa-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 13, 2022
Target sample size		120
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Men and women over 20 years old Adults with no history or symptoms of respiratory illness After sufficient informed consent to participate in this study, the patient's free will to give written consent.
	Exclusion Criteria	Those with hyperthyroidism Those with cardiovascular disease with bradycardia Those with peptic ulcer disease Those with Addison's disease Those with gastrointestinal or urinary tract obstruction Those with epilepsy Those with parkinsonism Those with vagal hypervagus Those with myasthenia gravis who regularly take cholinesterase inhibitors Those with moderate airflow limitation (%FEV1 <70% or FEV1 <1.5 L) Those who are pregnant or breastfeeding Those who have a fever of 37 degrees or higher Those who have been infected with the new coronavirus within the last month Those who are judged to be inappropriate by the principal investigator or co-investigator
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		cough variant asthma
Intervention(s)		Bronchial smooth muscle contraction by inhalation of provocholine Dissolve probocholine in physiological saline and prepare two-fold serial dilutions of 0.049, 0.098, 0.195, 0.391, 0.781, 1.563, 3.125, 6.25, 12.5, and 25 mg/ml. While measuring the respiratory resistance (Rrs) by the 3 Hz oscillation method using Astograph Jupiter 21, inhale the probocholine solution of the above concentration continuously for 1 minute each from the lowest concentration. The inhalation load was stopped immediately when Rrs increased to twice the initial value.
Health Condition(s) Keyword		cough variant astma, cough, methacholine
Intervention(s) Keyword		Bronchial contraction by inhalation of provocholine
Primary Outcome(s)		Total cough count for 30 minutes induced by inhalation of provocholine
Secondary Outcome(s)		Nothing

Primary Sponsor	Respiratory Medicine, Kanazawa University Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Clinical Trial Review Board of Kanazawa University Hospital
Address	13-1, Takara-machi, Kanazawa-city, Ishikawa, Ishikawa
Telephone	+81-76-265-2048
E-Mail	hpsangak@adm.kanazawa-u.ac.jp
Approval Status	Approval
Date of approval	April. 01, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	July. 27, 2026	(this page)	Changes
3	May. 12, 2025	Detail	Changes
2	April. 10, 2024	Detail	Changes
1	Dec. 13, 2022	Detail

List of change history