Trial Outcomes & Findings for Macrophage Phagocytosis in COPD (NCT NCT00298389)

NCT ID: NCT00298389

Last Updated: 2019-12-03

Results Overview

Measurement of phagocytosis in vitro, Phagocytosis of H. influenzae concentration

• Recruitment status: COMPLETED
• Target enrollment: 56 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2019-12-03

Participant Flow

Participant milestones

Measure	Non Smokers Non smokers included no history of respiratory or allergic disease, normal baseline spirometry	Smokers Smoking history of at least 10 pack years	COPD Patients with stable COPD
Overall Study STARTED	20	17	19
Overall Study COMPLETED	20	17	19
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	Non Smokers n=20 Participants Non smokers included no history of respiratory or allergic disease, normal baseline spirometry	Smokers n=17 Participants Smoking history of at least 10 pack years	COPD n=19 Participants Patients with stable COPD	Total n=56 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 3 • n=20 Participants	53 years STANDARD_DEVIATION 2 • n=17 Participants	70 years STANDARD_DEVIATION 2 • n=19 Participants	57 years STANDARD_DEVIATION 3 • n=56 Participants
Sex: Female, Male Female	9 Participants n=20 Participants	7 Participants n=17 Participants	8 Participants n=19 Participants	24 Participants n=56 Participants
Sex: Female, Male Male	11 Participants n=20 Participants	10 Participants n=17 Participants	11 Participants n=19 Participants	32 Participants n=56 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	20 participants n=20 Participants	17 participants n=17 Participants	19 participants n=19 Participants	56 participants n=56 Participants
Smoking history	0 pack/years STANDARD_DEVIATION 0 • n=20 Participants	33 pack/years STANDARD_DEVIATION 4.6 • n=17 Participants	45 pack/years STANDARD_DEVIATION 4.9 • n=19 Participants	15.3 pack/years STANDARD_DEVIATION 20 • n=56 Participants
FEV1 (%predicted)	102.7 percent predicted STANDARD_DEVIATION 2.6 • n=20 Participants	93.8 percent predicted STANDARD_DEVIATION 3.8 • n=17 Participants	50.6 percent predicted STANDARD_DEVIATION 4.0 • n=19 Participants	80.5 percent predicted STANDARD_DEVIATION 20 • n=56 Participants

PRIMARY outcome

Timeframe: 1 hour

Measurement of phagocytosis in vitro, Phagocytosis of H. influenzae concentration

Outcome measures

Measure	Non Smokers n=20 Participants Non smokers included no history of respiratory or allergic disease, normal baseline spirometry	Smokers n=17 Participants Smoking history of at least 10 pack years	COPD n=19 Participants Patients with stable COPD
Phagocytosis of H. Influenzae Concentration concentration 0.3g/ml	0.042 relative fluorescence unit Standard Error 0.008	0.042 relative fluorescence unit Standard Error 0.007	0.014 relative fluorescence unit Standard Error 0.002
Phagocytosis of H. Influenzae Concentration concentration 1g/ml	0.06 relative fluorescence unit Standard Error 0.01	0.059 relative fluorescence unit Standard Error 0.008	0.025 relative fluorescence unit Standard Error 0.004

PRIMARY outcome

Timeframe: 1 hour

Measurement of phagocytosis in vitro, Phagocytosis of S. pneumoniae concentration

Outcome measures

Measure	Non Smokers n=20 Participants Non smokers included no history of respiratory or allergic disease, normal baseline spirometry	Smokers n=17 Participants Smoking history of at least 10 pack years	COPD n=19 Participants Patients with stable COPD
Phagocytosis of S. Pneumoniae Concentration concentration 0.3g/ml	0.066 relative fluescence Standard Error 0.02	0.056 relative fluescence Standard Error 0.012	0.012 relative fluescence Standard Error 0.011
Phagocytosis of S. Pneumoniae Concentration concentration 1g/ml	0.077 relative fluescence Standard Error 0.021	0.072 relative fluescence Standard Error 0.016	0.022 relative fluescence Standard Error 0.014

Adverse Events

Non Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

COPD

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