Trial Outcomes & Findings for Inflammation and Corticosteroid Responsiveness in Severe Asthma (NCT NCT00180661)

NCT ID: NCT00180661

Last Updated: 2019-10-04

Results Overview

FEV1, or forced expiratory volume, is a measurement taken from a pulmonary function test. It calculates the amount of air that a person can force out of their lungs in 1 second.

• Recruitment status: COMPLETED
• Target enrollment: 39 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2019-10-04

Participant Flow

Participant milestones

Measure	Non-severe Asthma Patients with Non-severe asthma	Severe Asthma Patients with severe asthma
Overall Study STARTED	19	20
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Non-severe Asthma n=19 Participants Patients with Non-severe asthma	Severe Asthma n=20 Participants Patients with severe asthma	Total n=39 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 2.4 • n=19 Participants	41.4 years STANDARD_DEVIATION 2.6 • n=20 Participants	40.7 years STANDARD_DEVIATION 2.5 • n=39 Participants
Sex: Female, Male Female	7 Participants n=19 Participants	14 Participants n=20 Participants	21 Participants n=39 Participants
Sex: Female, Male Male	12 Participants n=19 Participants	6 Participants n=20 Participants	18 Participants n=39 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	19 participants n=19 Participants	20 participants n=20 Participants	39 participants n=39 Participants

PRIMARY outcome

Timeframe: 1 day

FEV1, or forced expiratory volume, is a measurement taken from a pulmonary function test. It calculates the amount of air that a person can force out of their lungs in 1 second.

Outcome measures

Measure	Non-severe Asthma n=19 Participants Patients with Non-severe asthma	Severe Asthma n=20 Participants Patients with severe asthma
Lung Function FEV1	84.9 % of predicted Standard Deviation 3	59.9 % of predicted Standard Deviation 4.4

PRIMARY outcome

Timeframe: 1 day

IL8 - Interleukin-8 (IL-8) is a cytokine produced by many normal cells including monocytes, neutrophils, fibroblasts, and endothelial cells

Outcome measures

Measure	Non-severe Asthma n=19 Participants Patients with Non-severe asthma	Severe Asthma n=20 Participants Patients with severe asthma
Suppression of Monocyte Activation and Alveolar Macrophage Activation by Dexamethasone Ex-vivo	30 % of supression Interval 25.0 to 75.0	10 % of supression Interval 5.0 to 10.0

PRIMARY outcome

Timeframe: Once

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Once

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Once

Population: No data collected

Outcome measures

Outcome data not reported

Adverse Events

Non-severe Asthma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Email: f.chung@imperial.ac.uk

Results disclosure agreements

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