Trial Outcomes & Findings for Exhaled Hydrogen Sulphide as a Biomarker of Airways Disease in Asthma (NCT NCT02703467)

Results Overview

Level of hydrogen sulphide in exhaled breath measured as parts per billion

Recruitment status

COMPLETED

Target enrollment

70 participants

Primary outcome timeframe

At baseline visit

Results posted on

2019-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Healthy participants	Mild-moderate Mild-moderate asthma patients	Severe Severe asthma patients
Overall Study STARTED	20	5	45
Overall Study COMPLETED	20	5	45
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy n=20 Participants Healthy participants	Mild-moderate n=5 Participants Mild-moderate asthma patients	Severe n=45 Participants Severe asthma patients	Total n=70 Participants Total of all reporting groups
Age, Continuous	51.1 years STANDARD_DEVIATION 3.5 • n=20 Participants	55.6 years STANDARD_DEVIATION 5.9 • n=5 Participants	55.9 years STANDARD_DEVIATION 11.5 • n=45 Participants	54.5 years STANDARD_DEVIATION 9.1 • n=70 Participants
Sex: Female, Male Female	13 Participants n=20 Participants	3 Participants n=5 Participants	31 Participants n=45 Participants	47 Participants n=70 Participants
Sex: Female, Male Male	7 Participants n=20 Participants	2 Participants n=5 Participants	14 Participants n=45 Participants	23 Participants n=70 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	20 participants n=20 Participants	5 participants n=5 Participants	45 participants n=45 Participants	70 participants n=70 Participants

PRIMARY outcome

Timeframe: At baseline visit

Level of hydrogen sulphide in exhaled breath measured as parts per billion

Outcome measures

Outcome measures
Measure	Healthy n=20 Participants Healthy participants	Mild-moderate n=5 Participants Mild-moderate asthma patients	Severe n=45 Participants Severe asthma patients
Hydrogen Sulphide in Exhaled Breath	5.0 parts per billion Standard Error 0.6	3.2 parts per billion Standard Error 1.0	4.9 parts per billion Standard Error 1.3

SECONDARY outcome

Timeframe: At baseline visit

Forced expiratory volume in one second as percent of predicted value (%)

Outcome measures

Outcome measures
Measure	Healthy n=20 Participants Healthy participants	Mild-moderate n=5 Participants Mild-moderate asthma patients	Severe n=45 Participants Severe asthma patients
FEV1	98.9 per cent of predicted value Standard Error 4.1	92.0 per cent of predicted value Standard Error 11.1	73.6 per cent of predicted value Standard Error 4.3

SECONDARY outcome

Timeframe: At 4 visits which occur during the study duration, up to 1 year

Forced vital capacity as per cent of predicted

Outcome measures

Outcome measures
Measure	Healthy n=20 Participants Healthy participants	Mild-moderate n=5 Participants Mild-moderate asthma patients	Severe n=45 Participants Severe asthma patients
FVC (Forced Vital Capacity)	105.1 per cent of predicted value (%) Standard Error 4.3	97.40 per cent of predicted value (%) Standard Error 15.3	88.22 per cent of predicted value (%) Standard Error 3.5

SECONDARY outcome

Timeframe: At 4 visits which occur during the study duration, up to 1 year

Levels of nitric oxide in exhaled breath in parts per billion

Outcome measures

Outcome measures
Measure	Healthy n=20 Participants Healthy participants	Mild-moderate n=5 Participants Mild-moderate asthma patients	Severe n=45 Participants Severe asthma patients
Exhaled Nitric Oxide	25.41 parts per billion Standard Error 6.3	39.42 parts per billion Standard Error 13.6	39.45 parts per billion Standard Error 2.2

SECONDARY outcome

Timeframe: At 4 visits which occur during the study duration, up to 1 year

Population: Data not collected

Hydrogen Sulpide level measurements from blood

Outcome measures

Outcome data not reported

Adverse Events

Healthy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mild-moderate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Severe

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Fan Chung

Imperial College London

Phone: 00442075947954

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place