Trial Outcomes & Findings for Leukocyte Function in Asthma and COPD (NCT NCT00147069)

NCT ID: NCT00147069

Last Updated: 2019-12-05

Results Overview

Sputum was induced via inhalation of hypertonic saline as previously described, and was processed for differential counts of inflammatory cells.

• Recruitment status: COMPLETED
• Target enrollment: 60 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-12-05

Participant Flow

Participant milestones

Measure	Controls Non-smoking control subjects without lung disease	Asthmatics Non-smokers patients with asthma	Non-COPD Smokers Current smokers without airways obstruction, FEV1 \>80% predicted	COPD Smokers Patients with COPD and cigarette smokers
Overall Study STARTED	15	15	15	15
Overall Study COMPLETED	15	15	15	15
Overall Study NOT COMPLETED	0	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 Smokers n=15 Participants Patients with COPD and cigarette smokers	Total n=60 Participants Total of all reporting groups	Controls n=15 Participants Non-smoking control subjects without lung disease	Asthmatics n=15 Participants Non-smokers patients with asthma	Non-COPD Smokers n=15 Participants Current smokers without airways obstruction, FEV1 \>80% predicted
Age, Continuous	60.7 years STANDARD_DEVIATION 2.6 • n=15 Participants	43.3 years STANDARD_DEVIATION 2 • n=60 Participants	30.5 years STANDARD_DEVIATION 1.4 • n=15 Participants	34.6 years STANDARD_DEVIATION 1.6 • n=15 Participants	47.6 years STANDARD_DEVIATION 2.6 • n=15 Participants
Sex: Female, Male Female	3 Participants n=15 Participants	31 Participants n=60 Participants	9 Participants n=15 Participants	9 Participants n=15 Participants	10 Participants n=15 Participants
Sex: Female, Male Male	12 Participants n=15 Participants	29 Participants n=60 Participants	6 Participants n=15 Participants	6 Participants n=15 Participants	5 Participants n=15 Participants
Race and Ethnicity Not Collected	—	0 Participants Race and Ethnicity were not collected from any participant.	—	—	—
Region of Enrollment United Kingdom	15 participants n=15 Participants	60 participants n=60 Participants	15 participants n=15 Participants	15 participants n=15 Participants	15 participants n=15 Participants
FEV1 percent predicted	45.2 percent predicted STANDARD_DEVIATION 3.1 • n=15 Participants	86 percent predicted STANDARD_DEVIATION 7 • n=60 Participants	104.9 percent predicted STANDARD_DEVIATION 1.7 • n=15 Participants	93.5 percent predicted STANDARD_DEVIATION 1.1 • n=15 Participants	100.9 percent predicted STANDARD_DEVIATION 1.2 • n=15 Participants

PRIMARY outcome

Timeframe: 1 year

Sputum was induced via inhalation of hypertonic saline as previously described, and was processed for differential counts of inflammatory cells.

Outcome measures

Measure	Controls n=15 Participants Non-smoking control subjects without lung disease	Asthmatics n=15 Participants Non-smokers patients with asthma	Non-COPD Smokers n=15 Participants Current smokers without airways obstruction, FEV1 \>80% predicted	COPD Smokers n=15 Participants Patients with COPD and cigarette smokers
Total Number of Inflammatory Cells Recovered in Sputum	2.3 10^6 cells/ml Standard Error 0.5	2.1 10^6 cells/ml Standard Error 0.4	1.9 10^6 cells/ml Standard Error 0.3	5.2 10^6 cells/ml Standard Error 1.5

PRIMARY outcome

Timeframe: 1 year

MMPs determined using paired antibody quantitative ELISAs

Outcome measures

Measure	Controls n=15 Participants Non-smoking control subjects without lung disease	Asthmatics n=15 Participants Non-smokers patients with asthma	Non-COPD Smokers n=15 Participants Current smokers without airways obstruction, FEV1 \>80% predicted	COPD Smokers n=15 Participants Patients with COPD and cigarette smokers
Number of Matrix Metalloproteases (MMPs) MMP1	11.0 ng/ml Standard Error 1.5	12.5 ng/ml Standard Error 1.7	16.5 ng/ml Standard Error 0.6	34.5 ng/ml Standard Error 3.2

PRIMARY outcome

Timeframe: 1 year

MMPs determined using paired antibody quantitative ELISAs

Outcome measures

Measure	Controls n=15 Participants Non-smoking control subjects without lung disease	Asthmatics n=15 Participants Non-smokers patients with asthma	Non-COPD Smokers n=15 Participants Current smokers without airways obstruction, FEV1 \>80% predicted	COPD Smokers n=15 Participants Patients with COPD and cigarette smokers
Number of Matrix Metalloproteases (MMPs) MMP3	7.2 ng/ml Standard Error 1.4	4.5 ng/ml Standard Error 0.8	5.8 ng/ml Standard Error 1.7	5.4 ng/ml Standard Error 1.1

PRIMARY outcome

Timeframe: 1 year

MMPs determined using paired antibody quantitative ELISAs

Outcome measures

Measure	Controls n=15 Participants Non-smoking control subjects without lung disease	Asthmatics n=15 Participants Non-smokers patients with asthma	Non-COPD Smokers n=15 Participants Current smokers without airways obstruction, FEV1 \>80% predicted	COPD Smokers n=15 Participants Patients with COPD and cigarette smokers
Number of Matrix Metalloproteases (MMPs) MMP8	208.6 ng/ml Standard Error 24.7	188.5 ng/ml Standard Error 29.4	443.5 ng/ml Standard Error 72	1575 ng/ml Standard Error 521

Adverse Events

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Asthmatics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-COPD Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

COPD 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: +44 (0)20 7594 7895

Email: l.donnelly@imperial.ac.uk

Results disclosure agreements

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