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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020430
Receipt No. R000023579
Scientific Title Measurement of Cough Response to Bronchoconstriction Induced by Methacholine: An Examination Using the Astograph Method
Date of disclosure of the study information 2016/01/04
Last modified on 2016/01/04

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Basic information
Public title Measurement of Cough Response to Bronchoconstriction Induced by
Methacholine: An Examination Using the Astograph Method
Acronym Cough Response to Bronchoconstriction induced by Methacholine using the Astograph Method
Scientific Title Measurement of Cough Response to Bronchoconstriction Induced by
Methacholine: An Examination Using the Astograph Method
Scientific Title:Acronym Cough Response to Bronchoconstriction induced by Methacholine using the Astograph Method
Region
Japan

Condition
Condition cough variant asthma
Classification by specialty
Pneumology Clinical immunology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The relationship in the cough response to bronchoconstriction induced by the methacholine provocation using the original method and the astograph method
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The total number of cough induced by two methods
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 day1 The measurement of cough response to bronchoconstriction induced by Methacholine using original method
day2 The measurement of cough response to bronchoconstriction induced by Methacholine using Astograph method

Twofold increasing concentrations of methacholine chloride diluted in physiologic saline in 13 dose steps (0.04 to 160 mg/mL) were prepared.

Original method
Methacholine was inhaled for 2 minutes by tidal breathing with the patient wearing a nose clip, which was followed immediately by measurements of partial and full flow-volume curves. Increasing concentrations of Methacholine were inhaled until a decrease of 35% or more in PC35-PEF40 from the baseline value occurred.
Coughs were counted for 2 minutes during the inhalation and for 30 minutes after the inhalation of Mch at concentrations of PC35-PEF40.

Astograph method
Methacholine inhalation challenge was performed by an astograph (Jupiter 21; CHEST; Tokyo, Japan), according to the method of Takishima et al. Briefly, respiratory resistance was measured by the forced oscillation method (3 Hz) during continuous inhalation of Methacholine in stepwise incremental concentrations, until Rrs reached twice the baseline value. Spirometry was measured before Methacholine inhalation challenge and immediately after the Rrs had increased twofold. At that time, if FEV1 did not decreased less than 90% of baseline value, inhalation of Methacholine was restarted at the same concentration. Coughs were counted manually by an observer, and cough counts for the interval beginning < 1min before, and for 30 min following inhalation of Methacholine at which Rrs and FEV1were archived.
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
29 years-old >=
Gender Male and Female
Key inclusion criteria Subjects with non-smoker, aged 20 to 29 years were eligible for the study.
Key exclusion criteria Subjects were excluded if they had a history of bronchial asthma, any clinically significant respiratory disorders, tachyarrhythmia, heart failure or disorder that might put them at risk or influence the study results or their ability to participate.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Johsuke hara
Organization Kanazawa University Graduate School of Medicine
Division name Respiratory Medicine, Cellular Transplantation Biology
Zip code
Address 13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL 076-265-2000
Email hara0728@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Johsuke hara
Organization Kanazawa University Graduate School of Medicine
Division name Respiratory Medicine, Cellular Transplantation Biology
Zip code
Address 13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL 076-265-2000
Homepage URL
Email hara0728@gmail.com

Sponsor
Institute Kanazawa University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kanazawa University Graduate School of Medicine
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
Address
Tel
Email

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 金沢大学附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 04 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
2014 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 25 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
2016 Year 01 Month 04 Day
Last modified on
2016 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023579

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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