Trial Outcomes & Findings for Chronic Obstructive Pulmonary Disease (COPD) Biomarker Identification Study (NCT NCT01780298)

Results Overview

Recruitment status

COMPLETED

Target enrollment

252 participants

Primary outcome timeframe

Up to 59 days

Results posted on

2025-01-14

Participant Flow

Study initiated (first subject enrolled): 01 July 2011

Participant milestones

Participant milestones
Measure	Group 1: COPD GOLD Stage 1-2 Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
Overall Study STARTED	62	65	64	61
Overall Study COMPLETED	60	60	60	60
Overall Study NOT COMPLETED	2	5	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: COPD GOLD Stage 1-2 Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
Overall Study Physician Decision	1	5	1	1
Overall Study Subject not matched	1	0	1	0
Overall Study Adverse Event	0	0	2	0

Baseline Characteristics

Chronic Obstructive Pulmonary Disease (COPD) Biomarker Identification Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: COPD GOLD Stage 1-2 n=62 Participants Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers n=65 Participants Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers n=64 Participants Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers n=61 Participants Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Total n=252 Participants Total of all reporting groups
Age, Continuous	57.161 years STANDARD_DEVIATION 7.159 • n=99 Participants	55.308 years STANDARD_DEVIATION 6.908 • n=107 Participants	56.344 years STANDARD_DEVIATION 7.392 • n=206 Participants	55.459 years STANDARD_DEVIATION 7.453 • n=7 Participants	56.063 years STANDARD_DEVIATION 7.223 • n=31 Participants
Sex: Female, Male Female	25 Participants n=99 Participants	29 Participants n=107 Participants	27 Participants n=206 Participants	26 Participants n=7 Participants	107 Participants n=31 Participants
Sex: Female, Male Male	37 Participants n=99 Participants	36 Participants n=107 Participants	37 Participants n=206 Participants	35 Participants n=7 Participants	145 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	4 Participants n=31 Participants
Race (NIH/OMB) White	60 Participants n=99 Participants	64 Participants n=107 Participants	63 Participants n=206 Participants	60 Participants n=7 Participants	247 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Body Mass Index	26.461 kg/m^2 STANDARD_DEVIATION 3.700 • n=99 Participants	27.568 kg/m^2 STANDARD_DEVIATION 3.657 • n=107 Participants	27.333 kg/m^2 STANDARD_DEVIATION 3.558 • n=206 Participants	26.479 kg/m^2 STANDARD_DEVIATION 3.719 • n=7 Participants	26.972 kg/m^2 STANDARD_DEVIATION 3.670 • n=31 Participants
Number of Cigarettes Smoked Per Day	20.611 Cig/day STANDARD_DEVIATION 9.412 • n=99 Participants	17.319 Cig/day STANDARD_DEVIATION 7.541 • n=107 Participants	22.422 Cig/day STANDARD_DEVIATION 9.135 • n=206 Participants	0 Cig/day STANDARD_DEVIATION 0 • n=7 Participants	15.233 Cig/day STANDARD_DEVIATION 11.611 • n=31 Participants
Pack-year	44.770 Pack-year STANDARD_DEVIATION 22.019 • n=99 Participants	33.404 Pack-year STANDARD_DEVIATION 14.577 • n=107 Participants	28.535 Pack-year STANDARD_DEVIATION 13.330 • n=206 Participants	0 Pack-year STANDARD_DEVIATION 0 • n=7 Participants	26.878 Pack-year STANDARD_DEVIATION 21.977 • n=31 Participants
Weekly Consumption of Alcohol	6.694 Units of alcohol STANDARD_DEVIATION 7.662 • n=99 Participants	5.923 Units of alcohol STANDARD_DEVIATION 6.310 • n=107 Participants	8.445 Units of alcohol STANDARD_DEVIATION 7.097 • n=206 Participants	5.775 Units of alcohol STANDARD_DEVIATION 6.711 • n=7 Participants	6.717 Units of alcohol STANDARD_DEVIATION 6.998 • n=31 Participants

PRIMARY outcome

Timeframe: Up to 59 days

Population: Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population.

Outcome measures

Outcome measures
Measure	Group 1: COPD GOLD Stage 1-2 n=60 Participants Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers n=60 Participants Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers n=60 Participants Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers n=60 Participants Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
Spirometry Measurement: Percentage of Predicted Forced Expiratory Volume in 1 Second (FEV1 %Pred)	75.572 percent of predicted FEV1 Interval 70.905 to 80.239	100.837 percent of predicted FEV1 Interval 97.801 to 103.873	108.311 percent of predicted FEV1 Interval 105.102 to 111.519	111.849 percent of predicted FEV1 Interval 108.258 to 115.44

PRIMARY outcome

Timeframe: Up to 59 days

Population: Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population.

Outcome measures

Outcome measures
Measure	Group 1: COPD GOLD Stage 1-2 n=60 Participants Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers n=60 Participants Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers n=60 Participants Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers n=60 Participants Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
Gas Transfer: Percentage of Predicted Total Diffusing Capacity of the Lungs for Carbon Monoxide (TLCO %Pred)	66.158 percent predicted TLCO Interval 61.981 to 70.334	80.264 percent predicted TLCO Interval 77.043 to 83.485	90.710 percent predicted TLCO Interval 87.134 to 94.286	93.768 percent predicted TLCO Interval 90.664 to 96.873

PRIMARY outcome

Timeframe: Up to 59 days

Population: Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population.

Outcome measures

Outcome measures
Measure	Group 1: COPD GOLD Stage 1-2 n=60 Participants Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers n=60 Participants Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers n=60 Participants Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers n=60 Participants Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Central Airway Resistance at 5Hz (R5 %Pred)	130.118 percent predicted R5 Interval 119.6 to 140.637	109.458 percent predicted R5 Interval 102.529 to 116.386	103.581 percent predicted R5 Interval 97.437 to 109.724	89.671 percent predicted R5 Interval 83.477 to 95.865

PRIMARY outcome

Timeframe: Up to 59 days

Population: Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population.

Outcome measures

Outcome measures
Measure	Group 1: COPD GOLD Stage 1-2 n=60 Participants Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers n=60 Participants Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers n=60 Participants Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers n=60 Participants Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Reactance at 5 Hz (X5 % Pred)	2808.259 percent predicted X5 Interval -794.944 to 6411.462	411.670 percent predicted X5 Interval -139.923 to 963.263	491.128 percent predicted X5 Interval 41.793 to 940.464	5787.984 percent predicted X5 Interval -902.669 to 12478.637

PRIMARY outcome

Timeframe: Up to 59 days

Population: Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population.

Outcome measures

Outcome measures
Measure	Group 1: COPD GOLD Stage 1-2 n=60 Participants Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers n=60 Participants Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers n=60 Participants Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers n=60 Participants Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
Impulse Oscillometry (IOS) Measurements: Resonant Frequency (Fres)	17.816 Hz Interval 16.588 to 19.043	14.362 Hz Interval 13.513 to 15.21	12.971 Hz Interval 12.083 to 13.859	11.800 Hz Interval 10.942 to 12.659

PRIMARY outcome

Timeframe: Up to 59 days

Population: Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population.

Stethographics analysis was performed using the 16-channel lung sound analyzer system STG1602 (Stethographics, Boston, MA, USA) following the supplier's recommendations. Lung sound data are obtained from an intermediate deeper-than-normal breath (pattern 2; P2). Each breath pattern is recorded for a minimum of 30 seconds allowing 3 to 6 breaths to be taken, with measurements completed over 3 to 4 minutes. Each of the 16 parameters derived from one measurement are evaluated and a score from 0 to 10 is assigned based on the value of the individual parameter. The total standard Acoustic COPD Score (ACOPDS) is calculated as the sum of the individual score for each parameter, which permits a maximum score of 160. Although this stethographics analysis system was considered experimental, a higher score was associated with poor health outcomes and a lower score with a better health state.

Outcome measures

Outcome measures
Measure	Group 1: COPD GOLD Stage 1-2 n=60 Participants Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers n=60 Participants Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers n=60 Participants Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers n=60 Participants Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
Stethographics Measurements: Non-Weighted Acoustic Chronic Obstructive Pulmonary Disease Scores (ACOPDS)	47.983 score on a scale Interval 42.723 to 53.244	18.817 score on a scale Interval 14.467 to 23.166	12.192 score on a scale Interval 9.025 to 15.358	8.350 score on a scale Interval 6.187 to 10.513

PRIMARY outcome

Timeframe: Up to 59 days

Population: Of the 252 enrolled subjects, 240 completed the study, but 235 were included in the analysis population as data were missing for 5 subjects: * 3 subjects in the group "COPD GOLD stage 1-2" * 1 subject in the group "Ex-smokers" * 1 subject in the group "Never smokers"

The MMRC scale uses a simple grading system to assess a subject's level of dyspnea (shortness of breath). Subjects were asked to grade the degree of breathlessness related to activities by choosing 1 of the following answers: * 0: Not troubles by breathlessness except on strenuous exercise * 1: Short of breath when hurrying or walking up a slight hill * 2: Walks slower than contemporaries on the level because of breathlessness, or has to stop for breath when walking at own pace * 3: Stops for breath after about 100 meters or after a few minutes on the level * 4: Too breathless to leave the house, or breathless when dressing or undressing.

Outcome measures

Outcome measures
Measure	Group 1: COPD GOLD Stage 1-2 n=57 Participants Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers n=60 Participants Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers n=59 Participants Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers n=59 Participants Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
Dyspnoea Assessment: Modified Medical Research Council (MMRC) Dyspnoea Scale	1.053 units on a scale Interval 0.821 to 1.285	0.417 units on a scale Interval 0.272 to 0.562	0.186 units on a scale Interval 0.073 to 0.3	0.119 units on a scale Interval -0.001 to 0.238

PRIMARY outcome

Timeframe: Up to 59 days

Population: Of the 252 enrolled subjects, 240 completed the study, but 233 were included in the analysis population as data were missing for 7 subjects: * 4 subjects in the group "COPD GOLD stage 1-2" * 1 subject in the group "Current cigarette smokers" * 1 subject in the group "Ex-smokers" * 1 subject in the group "Never smokers"

The BODE Index is a 10-point scale to assess prognostic factors in COPD patients. Body mass index ("B"), airway obstruction ("O"), dyspnea ("D"), and exercise tolerance ("E") are each graded on a 4 point scale (0 to 3), except body mass index (0 or 1) . The final BODE Index value is the sum of the scores for each prognostic factor, where a higher BODE score indicates a higher risk of death. The modified BODE (mBODE) index as defined by Lopez-Campos (2010) was used in this study, and is composed of the following factors: * Body mass index: (0 or 1) * Degree of airflow obstruction (FEV1% Pred): (0 to 3) * Functional dyspnea (MMRC Dyspnoea Scale): (0 to 3) * Exercise capacity (VO2max): (0 to 3) Lopez-Campos, José Luis, et al. "Modified BODE indexes: Agreement between multidimensional prognostic systems based on oxygen uptake." International Journal of Chronic Obstructive Pulmonary Disease (2010): 133-140.

Outcome measures

Outcome measures
Measure	Group 1: COPD GOLD Stage 1-2 n=56 Participants Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers n=59 Participants Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers n=59 Participants Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers n=59 Participants Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
Prediction of Mortality and Hospitalizations: Modified BODE Index (mBODE)	2.357 score on a scale Interval 1.998 to 2.716	1.254 score on a scale Interval 1.035 to 1.474	1.051 score on a scale Interval 0.827 to 1.275	0.763 score on a scale Interval 0.555 to 0.97

PRIMARY outcome

Timeframe: Up to 59 days

Population: Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population.

CT scans were assessed by two radiologists. A scoring system from 0 to 4 was applied, depending upon the component: 1. Extent of disease (emphysema): 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe 2. Severity of bronchial dilatation: 0=none; 1=mild (1.5x to 2.5x diameter of pulmonary artery); 2=severe (\>2.5x diameter of pulmonary artery) 3. Traction bronchiectasis: 0=none; 1=mild (1.5x to 2.5x diameter); 2=severe (\>2.5x diameter). 4. Total bronchiectasis score derived by adding the bronchial dilatation and traction bronchiectasis scores 5. Bronchial wall thickening: 0=none; 1=0.5x; 2=0.5-1x; 3= \>1x the diameter of the adjacent pulmonary artery 6. Small airways disease: 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe The total score (higher score indicated a poor outcome) was derived from the mean of all scores. This is described in Chaudhary, Nveed, et al. "Physiological and biological characterization of smokers with and without COPD." F1000Research 6 (2017).

Outcome measures

Outcome measures
Measure	Group 1: COPD GOLD Stage 1-2 n=60 Participants Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers n=60 Participants Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers n=60 Participants Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers n=60 Participants Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
High-Resolution Computerised Tomography (HRCT) of the Chest	0.939 score on a scale Interval 0.867 to 1.011	0.803 score on a scale Interval 0.723 to 0.884	0.683 score on a scale Interval 0.613 to 0.753	0.567 score on a scale Interval 0.488 to 0.646

Adverse Events

Group 1: COPD GOLD Stage 1-2

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Group 2: Current Cigarette Smokers

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Group 3: Ex-Smokers

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Group 4: Never Smokers

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group 1: COPD GOLD Stage 1-2 n=62 participants at risk Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history.	Group 2: Current Cigarette Smokers n=65 participants at risk Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 3: Ex-Smokers n=64 participants at risk Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years).	Group 4: Never Smokers n=61 participants at risk Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years).
Infections and infestations Influenza	4.8% 3/62 • Number of events 3 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	6.2% 4/65 • Number of events 4 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	3.1% 2/64 • Number of events 2 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	0.00% 0/61 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study
Infections and infestations Nasopharyngitis	4.8% 3/62 • Number of events 3 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	6.2% 4/65 • Number of events 4 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	4.7% 3/64 • Number of events 3 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	8.2% 5/61 • Number of events 5 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study
Investigations Computerised tomogram abnormal	19.4% 12/62 • Number of events 12 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	43.1% 28/65 • Number of events 28 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	23.4% 15/64 • Number of events 15 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	39.3% 24/61 • Number of events 24 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study
Investigations Liver scan abnormal	9.7% 6/62 • Number of events 6 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	0.00% 0/65 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	1.6% 1/64 • Number of events 1 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	3.3% 2/61 • Number of events 2 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study
Investigations Pulmonary function challenge test abnormal	14.5% 9/62 • Number of events 9 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	24.6% 16/65 • Number of events 16 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	18.8% 12/64 • Number of events 12 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	24.6% 15/61 • Number of events 15 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	22.6% 14/62 • Number of events 14 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	18.5% 12/65 • Number of events 12 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	10.9% 7/64 • Number of events 7 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	6.6% 4/61 • Number of events 4 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study
Nervous system disorders Headache	16.1% 10/62 • Number of events 10 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	9.2% 6/65 • Number of events 6 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	6.2% 4/64 • Number of events 4 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	11.5% 7/61 • Number of events 7 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study
Respiratory, thoracic and mediastinal disorders Bronchial wall thickening	0.00% 0/62 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	0.00% 0/65 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	0.00% 0/64 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	6.6% 4/61 • Number of events 4 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study
Respiratory, thoracic and mediastinal disorders Emphysema	1.6% 1/62 • Number of events 1 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	9.2% 6/65 • Number of events 6 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	1.6% 1/64 • Number of events 1 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study	0.00% 0/61 • From the informed consent form until the end of the study. The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study

Additional Information

Julia HOENG, PhD

Philip Morris Products S.A.

Phone: +41 (58) 242 2214

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee We confirm we have the contractual provisions in place which specifies that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements. The Intellectual Property rights and research results from the present study belongs to the Sponsor.
Publication restrictions are in place

Restriction type: OTHER