Trial Outcomes & Findings for Leukocyte Function in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00147082)

NCT ID: NCT00147082

Last Updated: 2019-12-05

Results Overview

Migration response of PBMC to Chemokine EC 50 represents the concentration of a drug that is required for 50% inhibition in vitro

• Recruitment status: COMPLETED
• Target enrollment: 100 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2019-12-05

Participant Flow

Participant milestones

Measure	COPD Patients with COPD - no intervention	Smokers Without COPD Smokers without COPD - no intervention	Non-smokers Non-smokers with no history of respiratory disease - no intervention
Overall Study STARTED	37	33	30
Overall Study COMPLETED	37	33	30
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

Measure	COPD n=37 Participants Patients with COPD - no intervention	Smokers Without COPD n=33 Participants Smokers without COPD - no intervention	Non-smokers n=30 Participants Non-smokers with no history of respiratory disease - no intervention	Total n=100 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 10 • n=37 Participants	40 years STANDARD_DEVIATION 12 • n=33 Participants	34 years STANDARD_DEVIATION 8 • n=30 Participants	47.45 years STANDARD_DEVIATION 10 • n=100 Participants
Sex: Female, Male Female	13 Participants n=37 Participants	15 Participants n=33 Participants	13 Participants n=30 Participants	41 Participants n=100 Participants
Sex: Female, Male Male	24 Participants n=37 Participants	18 Participants n=33 Participants	17 Participants n=30 Participants	59 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	37 participants n=37 Participants	33 participants n=33 Participants	30 participants n=30 Participants	100 participants n=100 Participants
Smoking History	48 pack/years STANDARD_DEVIATION 27 • n=37 Participants	21 pack/years STANDARD_DEVIATION 16 • n=33 Participants	0 pack/years STANDARD_DEVIATION 0 • n=30 Participants	24.7 pack/years STANDARD_DEVIATION 21 • n=100 Participants
FEV1 (% predicted)	47 % predicted STANDARD_DEVIATION 15 • n=37 Participants	93 % predicted STANDARD_DEVIATION 21 • n=33 Participants	102 % predicted STANDARD_DEVIATION 14 • n=30 Participants	78.7 % predicted STANDARD_DEVIATION 17 • n=100 Participants

PRIMARY outcome

Timeframe: 2 hours

Migration response of PBMC to Chemokine EC 50 represents the concentration of a drug that is required for 50% inhibition in vitro

Outcome measures

Measure	COPD n=37 Participants Patients with COPD - no intervention	Smokers Without COPD n=33 Participants Smokers without COPD - no intervention	Non-smokers n=30 Participants Non-smokers with no history of respiratory disease - no intervention
Effective Concentration (EC 50) of GRO Alpha	1.5 ng/ml Standard Error 0.9	0.9 ng/ml Standard Error 0.2	0.6 ng/ml Standard Error 0.3

PRIMARY outcome

Timeframe: 2 hours

Migration response of PBMC to Chemokine EC 50 represents the concentration of a drug that is required for 50% inhibition in vitro

Outcome measures

Measure	COPD n=37 Participants Patients with COPD - no intervention	Smokers Without COPD n=33 Participants Smokers without COPD - no intervention	Non-smokers n=30 Participants Non-smokers with no history of respiratory disease - no intervention
Effective Concentration of IL-8	0.2 ng/ml Standard Error 0.1	1.4 ng/ml Standard Error 0.4	0.8 ng/ml Standard Error 0.4

PRIMARY outcome

Timeframe: 2 hours

Migration response of PBMC to Chemokine

Outcome measures

Measure	COPD n=37 Participants Patients with COPD - no intervention	Smokers Without COPD n=33 Participants Smokers without COPD - no intervention	Non-smokers n=30 Participants Non-smokers with no history of respiratory disease - no intervention
Effective Concentration of MCP-1	0.5 ng/ml Standard Error 0.4	0.2 ng/ml Standard Error 0.2	0.3 ng/ml Standard Error 0.3

Adverse Events

COPD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smokers Without COPD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-smokers

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 Louise Donnelly

Imperial College London

Phone: +442075947895

Email: l.donnelly@imperial.ac.uk

Results disclosure agreements

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