Trial Outcomes & Findings for Regulation of the Release of Inflammatory Mediators From Lung Macrophages. (NCT NCT00147017)

NCT ID: NCT00147017

Last Updated: 2019-12-10

Results Overview

measure release of inflammatory mediators from isolated macrophages

• Recruitment status: COMPLETED
• Target enrollment: 17 participants
• Primary outcome timeframe: 20 hours
• Results posted on: 2019-12-10

Participant Flow

Participant milestones

Measure	Smokers All subjects had a smoking history of \>15 pack years	Ex-smokers Ex-smokers had ceased smoking for \>6 months.	Emphysema Lung Transplant The emphysema subjects were all undergoing lung transplants.
Overall Study STARTED	6	7	4
Overall Study COMPLETED	6	7	4
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	Smokers n=6 Participants All subjects had a smoking history of \>15 pack years	Ex-smokers n=7 Participants Ex-smokers had ceased smoking for \>6 months.	Emphysema Lung Transplant n=4 Participants The emphysema subjects were all undergoing lung transplants.	Total n=17 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 3.2 • n=6 Participants	52.3 years STANDARD_DEVIATION 3.7 • n=7 Participants	52.0 years STANDARD_DEVIATION 0.8 • n=4 Participants	53.4 years STANDARD_DEVIATION 2.6 • n=17 Participants
Sex: Female, Male Female	3 Participants n=6 Participants	4 Participants n=7 Participants	1 Participants n=4 Participants	8 Participants n=17 Participants
Sex: Female, Male Male	3 Participants n=6 Participants	3 Participants n=7 Participants	3 Participants n=4 Participants	9 Participants n=17 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	6 participants n=6 Participants	7 participants n=7 Participants	4 participants n=4 Participants	17 participants n=17 Participants
Smoking history	34.3 pack/years STANDARD_DEVIATION 8.4 • n=6 Participants	41.0 pack/years STANDARD_DEVIATION 16.3 • n=7 Participants	NA pack/years STANDARD_DEVIATION NA • n=4 Participants	37.9 pack/years STANDARD_DEVIATION 12.3 • n=17 Participants
FEV1 (% predicted)	87.9 % predicted STANDARD_DEVIATION 6.1 • n=6 Participants	83.2 % predicted STANDARD_DEVIATION 3.5 • n=7 Participants	NA % predicted STANDARD_DEVIATION NA • n=4 Participants	85.4 % predicted STANDARD_DEVIATION 4.8 • n=17 Participants

PRIMARY outcome

Timeframe: 20 hours

measure release of inflammatory mediators from isolated macrophages

Outcome measures

Measure	Smokers n=6 Participants All subjects had a smoking history of \>15 pack years	Ex-smokers n=7 Participants Ex-smokers had ceased smoking for \>6 months.	Emphysema Lung Transplant n=4 Participants The emphysema subjects were all undergoing lung transplants.
Macrophage Activation, TNF-a	6.1 ng/ml Standard Error 2.2	3.8 ng/ml Standard Error 1.5	2.6 ng/ml Standard Error 1.2

PRIMARY outcome

Timeframe: 20 hours

GM-CSF, granulocyte macrophage-colony stimulating factor

Outcome measures

Measure	Smokers n=6 Participants All subjects had a smoking history of \>15 pack years	Ex-smokers n=7 Participants Ex-smokers had ceased smoking for \>6 months.	Emphysema Lung Transplant n=4 Participants The emphysema subjects were all undergoing lung transplants.
Macrophage Activation, GM-CSF	2.2 ng/ml Standard Error 0.5	1.8 ng/ml Standard Error 0.5	2.6 ng/ml Standard Error 1.2

PRIMARY outcome

Timeframe: 20 hours

Outcome measures

Measure	Smokers n=6 Participants All subjects had a smoking history of \>15 pack years	Ex-smokers n=7 Participants Ex-smokers had ceased smoking for \>6 months.	Emphysema Lung Transplant n=4 Participants The emphysema subjects were all undergoing lung transplants.
Interleukin, IL-8	220.8 ng/ml Standard Error 67.1	251.2 ng/ml Standard Error 58.7	167.8 ng/ml Standard Error 49.5

Adverse Events

Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ex-smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Emphysema Lung Transplant

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