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Trial Outcomes & Findings for Exacerbations in Severe Asthma Patients: Mechanisms and Biomarkers (NCT NCT02660853)

NCT ID: NCT02660853

Last Updated: 2019-12-03

Results Overview

From date of screening visit until date of first asthma exacerbation visit Percent predicted Forced Expiratory Volume in First Second

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Baseline Visit, 12 months

Results posted on

2019-12-03

Participant Flow

Participant milestones

Participant milestones
Measure
Severe Asthma
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines, Observational study
Overall Study
STARTED
25
Overall Study
COMPLETED
25
Overall Study
NOT COMPLETED
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
Severe Asthma
n=25 Participants
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Age, Continuous
55.9 years
STANDARD_DEVIATION 11.5 • n=25 Participants
Sex: Female, Male
Female
17 Participants
n=25 Participants
Sex: Female, Male
Male
8 Participants
n=25 Participants
Region of Enrollment
United Kingdom
25 participants
n=25 Participants

PRIMARY outcome

Timeframe: Baseline Visit, 12 months

From date of screening visit until date of first asthma exacerbation visit Percent predicted Forced Expiratory Volume in First Second

Outcome measures

Outcome measures
Measure
Severe Asthma
n=25 Participants
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Percent Predicted FEV1
baseline
58.6 % of predicted value
Standard Deviation 20.4
Percent Predicted FEV1
During exacerbation
56.3 % of predicted value
Standard Deviation 22.2

SECONDARY outcome

Timeframe: Baseline Visit, 12 months

Population: No data collected

pH and free Iron

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Visit, 12 months

malondialdehyde (MDA)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Visit, 12 months

8-isoprostanes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline visit and 12 months

Population: Severe asthma at baseline

Eosinophils as percentage of total count

Outcome measures

Outcome measures
Measure
Severe Asthma
n=25 Participants
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Sputum Analysis
Baseline
10.9 Percentage of total sputum counts
Standard Deviation 30.6
Sputum Analysis
At exacerbation
4.47 Percentage of total sputum counts
Standard Deviation 9.47

SECONDARY outcome

Timeframe: Baseline Visit, 12 months

Population: No data collected

nasopharyngeal swabs

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Visit, 12 months

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Visit, 12 months

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Visit, 12 months

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Visit, 12 months

Population: Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Severe Asthma

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

Results disclosure agreements

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