Trial Outcomes & Findings for Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma (NCT NCT02097537)

NCT ID: NCT02097537

Last Updated: 2017-03-29

Results Overview

The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer. For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more. The concentration of methacholine causing 20% fall in FEV1 is PC20.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 10 participants
• Primary outcome timeframe: Visit 1 (Day 1)
• Results posted on: 2017-03-29

Participant Flow

Participant milestones

Measure	Methacholine Chloride children with bronchial asthma Methacholine Chloride (SK-1211)
Overall Study STARTED	10
Overall Study Enrollment	10
Overall Study Follow-Up	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

Baseline characteristics by cohort

Measure	Methacholine Chloride n=10 Participants children with bronchial asthma Methacholine Chloride (SK-1211)
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	10.7 years STANDARD_DEVIATION 2.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Japan	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 1 (Day 1)

The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer.

For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more.

The concentration of methacholine causing 20% fall in FEV1 is PC20.

Outcome measures

Measure	Methacholine Chloride n=10 Participants children with bronchial asthma Methacholine Chloride (SK-1211)
The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL	7 percentage of the subjects

SECONDARY outcome

Timeframe: Visit 1 (Day 1)

Outcome measures

Measure	Methacholine Chloride n=10 Participants children with bronchial asthma Methacholine Chloride (SK-1211)
The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation	7 percentage of the subjects

SECONDARY outcome

Timeframe: Visit 1 (Day 1)

PC20 : the concentration of methacholine causing 20% fall in FEV1.

Outcome measures

Measure	Methacholine Chloride n=10 Participants children with bronchial asthma Methacholine Chloride (SK-1211)
The Summary Statistics of PC20	8.0674 mg/mL Standard Deviation 11.7127

Adverse Events

Methacholine Chloride

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Methacholine Chloride n=10 participants at risk children with bronchial asthma Methacholine Chloride (SK-1211)
Respiratory, thoracic and mediastinal disorders Cough	40.0% 4/10 • Visit 1 (Day 1)
Respiratory, thoracic and mediastinal disorders Choking sensation	10.0% 1/10 • Visit 1 (Day 1)
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 1/10 • Visit 1 (Day 1)
Investigations Breath sounds abnormal	10.0% 1/10 • Visit 1 (Day 1)

Additional Information

General Manager of Clinical Development Group

Santen Pharmaceutical Co., Ltd.

Email: clinical@santen.co.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place