UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020430
Receipt number 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 20:51:46

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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 or person

Institute

Kanazawa University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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