Trial Outcomes & Findings for The Natural History of Small Airways Physiology in Diseased and Healthy States (NCT NCT00677560)

Results Overview

Forced expiratory volume in one second

Recruitment status

COMPLETED

Target enrollment

126 participants

Primary outcome timeframe

120 minutes

Results posted on

2021-12-20

Participant Flow

This was a single centre cross-sectional and longitudinal study involving asthmatic and chronic obstructive pulmonary disease (COPD) patients and healthy volunteers (including smokers). Subjects were between the ages of 18-85 years old, were given a patient information sheet and provided their written informed consent. Subjects were interviewed at visit 1 and a medical history was documented.

Participant milestones

Participant milestones
Measure	Mild-moderate Asthma Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Severe Asthma Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Normal Subjects This group consisted of 29 never-smokers with no history of respiratory disease.	Healthy Smokers Healthy smokers had no history of respiratory disease, and were all current smokers	COPD (Gold Stage I - III) COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
Overall Study STARTED	20	23	29	20	34
Overall Study COMPLETED	5	13	6	3	21
Overall Study NOT COMPLETED	15	10	23	17	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Natural History of Small Airways Physiology in Diseased and Healthy States

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Subjects n=29 Participants This group consisted of 29 never-smokers with no history of respiratory disease	Healthy Smokers n=20 Participants The healthy smoking group consisted of 20 current smokers with no history of respiratory disease	Mild-moderate Asthma n=20 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Severe Asthma n=23 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	COPD (Gold Stage I - III) n=34 Participants COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).	Total n=126 Participants Total of all reporting groups
Age, Continuous	50 years STANDARD_DEVIATION 15 • n=5 Participants	55 years STANDARD_DEVIATION 10 • n=7 Participants	41 years STANDARD_DEVIATION 15 • n=5 Participants	50 years STANDARD_DEVIATION 14 • n=4 Participants	66 years STANDARD_DEVIATION 7 • n=21 Participants	54 years STANDARD_DEVIATION 15 • n=10 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	6 Participants n=4 Participants	16 Participants n=21 Participants	58 Participants n=10 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants	18 Participants n=21 Participants	68 Participants n=10 Participants
Height	168.2 centimeters STANDARD_DEVIATION 10.7 • n=5 Participants	167.2 centimeters STANDARD_DEVIATION 11.3 • n=7 Participants	174.3 centimeters STANDARD_DEVIATION 10.1 • n=5 Participants	168.7 centimeters STANDARD_DEVIATION 8.5 • n=4 Participants	164.4 centimeters STANDARD_DEVIATION 8.5 • n=21 Participants	168.1 centimeters STANDARD_DEVIATION 10.1 • n=10 Participants
Weight	73.05 kilogram STANDARD_DEVIATION 17.99 • n=5 Participants	66.95 kilogram STANDARD_DEVIATION 15.55 • n=7 Participants	76.30 kilogram STANDARD_DEVIATION 17.19 • n=5 Participants	76.00 kilogram STANDARD_DEVIATION 13.18 • n=4 Participants	69.75 kilogram STANDARD_DEVIATION 14.04 • n=21 Participants	72.2 kilogram STANDARD_DEVIATION 15.8 • n=10 Participants
BMI	25.63 kg/m^2 STANDARD_DEVIATION 4.80 • n=5 Participants	23.90 kg/m^2 STANDARD_DEVIATION 4.82 • n=7 Participants	24.90 kg/m^2 STANDARD_DEVIATION 4.04 • n=5 Participants	26.89 kg/m^2 STANDARD_DEVIATION 5.64 • n=4 Participants	25.76 kg/m^2 STANDARD_DEVIATION 4.57 • n=21 Participants	25.5 kg/m^2 STANDARD_DEVIATION 4.8 • n=10 Participants
Smoking status Current smokers	0 participants n=5 Participants	20 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	10 participants n=21 Participants	30 participants n=10 Participants
Smoking status Ex-smokers	0 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	22 participants n=21 Participants	26 participants n=10 Participants

PRIMARY outcome

Timeframe: 120 minutes

Forced expiratory volume in one second

Outcome measures

Outcome measures
Measure	Mild-moderate Asthma n=20 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Severe Asthma n=23 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Normal Subjects n=29 Participants This group consisted of 29 never-smokers with no history of respiratory disease	Healthy Smokers n=20 Participants The healthy smoking group consisted of 20 current smokers with no history of respiratory disease	COPD (Gold Stage I-III) n=34 Participants COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
FEV1	3.03 L Standard Deviation 0.80	2.32 L Standard Deviation 0.88	3.18 L Standard Deviation 0.79	2.76 L Standard Deviation 0.73	1.67 L Standard Deviation 0.44

SECONDARY outcome

Timeframe: 120 minutes

Nitric oxide arising from the alveolar compartment.

Outcome measures

Outcome measures
Measure	Mild-moderate Asthma n=20 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Severe Asthma n=23 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Normal Subjects n=29 Participants This group consisted of 29 never-smokers with no history of respiratory disease	Healthy Smokers n=20 Participants The healthy smoking group consisted of 20 current smokers with no history of respiratory disease	COPD (Gold Stage I-III) n=34 Participants COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
Calv	4.3 ppb Standard Error 3.6	3.8 ppb Standard Error 3.2	2.9 ppb Standard Error 1.7	4.6 ppb Standard Error 2.9	3.7 ppb Standard Error 2.6

SECONDARY outcome

Timeframe: 120 minutes

Reactance area for whole-breath

Outcome measures

Outcome measures
Measure	Mild-moderate Asthma n=20 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Severe Asthma n=23 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Normal Subjects n=29 Participants This group consisted of 29 never-smokers with no history of respiratory disease	Healthy Smokers n=20 Participants The healthy smoking group consisted of 20 current smokers with no history of respiratory disease	COPD (Gold Stage I-III) n=34 Participants COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
AX	1.03 kPa/L Standard Deviation 1.05	1.88 kPa/L Standard Deviation 2.20	0.55 kPa/L Standard Deviation 0.57	0.82 kPa/L Standard Deviation 0.93	2.48 kPa/L Standard Deviation 2.12

SECONDARY outcome

Timeframe: 120 minutes

Resistance measured at 5 hertz during expiration

Outcome measures

Outcome measures
Measure	Mild-moderate Asthma n=20 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Severe Asthma n=23 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Normal Subjects n=29 Participants This group consisted of 29 never-smokers with no history of respiratory disease	Healthy Smokers n=20 Participants The healthy smoking group consisted of 20 current smokers with no history of respiratory disease	COPD (Gold Stage I-III) n=34 Participants COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
R5 EX	0.50 kPa/L/s Standard Deviation 0.17	0.60 kPa/L/s Standard Deviation 0.21	0.45 kPa/L/s Standard Deviation 0.16	0.50 kPa/L/s Standard Deviation 0.25	0.66 kPa/L/s Standard Deviation 0.24

SECONDARY outcome

Timeframe: 120 minutes

Bronchial nitric oxide flux

Outcome measures

Outcome measures
Measure	Mild-moderate Asthma n=20 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Severe Asthma n=23 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Normal Subjects n=29 Participants This group consisted of 29 never-smokers with no history of respiratory disease	Healthy Smokers n=20 Participants The healthy smoking group consisted of 20 current smokers with no history of respiratory disease	COPD (Gold Stage I-III) n=34 Participants COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
J'aw	138.5 nl/s Standard Deviation 85	77.2 nl/s Standard Deviation 62.4	76.2 nl/s Standard Deviation 46.1	35.4 nl/s Standard Deviation 21.2	60.7 nl/s Standard Deviation 47.6

SECONDARY outcome

Timeframe: 120 minutes

Ventilation heterogeneity within the acinar airways

Outcome measures

Outcome measures
Measure	Mild-moderate Asthma n=20 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Severe Asthma n=23 Participants Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).	Normal Subjects n=29 Participants This group consisted of 29 never-smokers with no history of respiratory disease	Healthy Smokers n=20 Participants The healthy smoking group consisted of 20 current smokers with no history of respiratory disease	COPD (Gold Stage I-III) n=34 Participants COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
Sacin	0.122 /L Standard Deviation 0.094	0.214 /L Standard Deviation 0.194	0.089 /L Standard Deviation 0.051	0.150 /L Standard Deviation 0.084	0.346 /L Standard Deviation 0.139

SECONDARY outcome

Timeframe: 120 minutes

Population: Not all subjects have results for this parameter which is why the total number of results will not equal the number of participants recruited.

Ventilation heterogeneity within the conducting airways