Trial Outcomes & Findings for Indirect Cost of Illness Study of Moderate and Severe Asthma in Quebec (NCT NCT02153346)

NCT ID: NCT02153346

Last Updated: 2018-08-17

Results Overview

Participants completed questionnaires within 2 weeks post-recruitment, 4, 8 and 12 months to measure indirect cost of disease, specifically related to productivity. The following questionnaires were used: WPAI helps to determine presenteeism, absenteeism, and total cost calculation (TCC) possible (number of days during the year of study), while VOLP is used to assess the impact of health conditions on lost productivity in monetary units (United states dollars). The following parameters were calculated: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

BL and at 12-month FUP

Results posted on

2018-08-17

Participant Flow

Participants (par.) in this cohort study were randomly selected from the BD-Asthma/RESP registry in Quebec, with an asthma diagnosis between June 2014 and January 2015, more than 18 years of age, and followed at the outpatient clinics of Hôpital du Sacré-Coeur de Montréal (HSCM), a tertiary care clinic specialized in asthma.

187 participants were selected in the BD-Asthma/RESP database; 160 were contacted of which 101 participants were enrolled in the study. 59 refused to participate. Participants were not assigned to any investigational therapies.

Participant milestones

Participant milestones
Measure
BD-Asthma/RESP
Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
Overall Study
STARTED
101
Overall Study
COMPLETED
90
Overall Study
NOT COMPLETED
11

Reasons for withdrawal

Reasons for withdrawal
Measure
BD-Asthma/RESP
Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
Overall Study
Lost to Follow-up
11

Baseline Characteristics

Indirect Cost of Illness Study of Moderate and Severe Asthma in Quebec

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
BD-Asthma/RESP
n=101 Participants
Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
Age, Continuous
53.5 Years
STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male
Female
65 Participants
n=5 Participants
Sex: Female, Male
Male
36 Participants
n=5 Participants
Education
None
9 Participants
n=5 Participants
Education
High school
27 Participants
n=5 Participants
Education
College
15 Participants
n=5 Participants
Education
University
41 Participants
n=5 Participants
Education
missing
1 Participants
n=5 Participants
Smoking habits
Ex-smokers
44 Participants
n=5 Participants
Smoking habits
Current smokers
10 Participants
n=5 Participants
Smoking habits
Never smokers
46 Participants
n=5 Participants
Smoking habits
missing
1 Participants
n=5 Participants
Number of years with asthma
20.7 Years
STANDARD_DEVIATION 16.7 • n=5 Participants
Control
1.4 ACQ Score
STANDARD_DEVIATION 0.9 • n=5 Participants
Age of Asthma onset
32.7 Years
STANDARD_DEVIATION 19.1 • n=5 Participants
FEV1
89.3 Percent predicted
STANDARD_DEVIATION 23.0 • n=5 Participants
FEV1/FVC
75.1 Percent
STANDARD_DEVIATION 9.4 • n=5 Participants
BMI
<18.5
3 Participants
n=5 Participants
BMI
18.5-24.9
18 Participants
n=5 Participants
BMI
25.0-29.9
38 Participants
n=5 Participants
BMI
>=30.0
39 Participants
n=5 Participants
BMI
missing
3 Participants
n=5 Participants
Number of years at the HSCM asthma clinic
10.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
Asthma severity
Mild
1 Participants
n=5 Participants
Asthma severity
Moderate
56 Participants
n=5 Participants
Asthma severity
Severe
26 Participants
n=5 Participants
Asthma severity
missing
18 Participants
n=5 Participants
Employment Status
Full time
37 Participants
n=5 Participants
Employment Status
Part-time as an employee
13 Participants
n=5 Participants
Employment Status
Self-employed
9 Participants
n=5 Participants
Employment Status
Work disability
6 Participants
n=5 Participants
Employment Status
Unemployed but seeking work
1 Participants
n=5 Participants
Employment Status
Retired
35 Participants
n=5 Participants

PRIMARY outcome

Timeframe: BL and at 12-month FUP

Population: Source Population: all par. with asthma diagnosed by respirologist and followed at outpatient asthma clinic of the HSCM and registered in BD-Asthma/RESP. Only par. with available data in each category (represented by n=X in the category title) were analyzed. One third of par. selected were retired. Only 59 were active workers (52 at BL; 40 at FUP).

Participants completed questionnaires within 2 weeks post-recruitment, 4, 8 and 12 months to measure indirect cost of disease, specifically related to productivity. The following questionnaires were used: WPAI helps to determine presenteeism, absenteeism, and total cost calculation (TCC) possible (number of days during the year of study), while VOLP is used to assess the impact of health conditions on lost productivity in monetary units (United states dollars). The following parameters were calculated: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA).

Outcome measures

Outcome measures
Measure
BD-Asthma/RESP
n=52 Participants
Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)
BL,CPA TCC, n=46
18.4 US Dollars
Standard Deviation 82.0
Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)
BL, CAA, n=52
253.3 US Dollars
Standard Deviation 847.5
Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)
FUP, CAA, n=40
70.4 US Dollars
Standard Deviation 157.6
Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)
BL,CPA,n=50
16.9 US Dollars
Standard Deviation 78.8
Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)
FUP,CPA, n=39
17.1 US Dollars
Standard Deviation 37.2
Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)
BL,CAA TCC, n=46
183.3 US Dollars
Standard Deviation 648.2
Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)
FUP,CAA TCC,n=37
76.10 US Dollars
Standard Deviation 162.64
Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)
FUP,CPA TCC,n=37
17.1 US Dollars
Standard Deviation 37.20
Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)
BL,TICA,n=46
201.7 US Dollars
Standard Deviation 723.7
Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)
FUP, TICA, n=37
93.2 US Dollars
Standard Deviation 182.3

PRIMARY outcome

Timeframe: BL and 12-month FUP

Population: Source Population. Only participants with available data in each category (represented by n=X in the category title) were analyzed. One third of the participants selected were retired. Only 59 participants were active workers. Therefore the stratification for asthma control and severity included very low numbers (52 at BL; 40 at FUP).

Costs of asthma are greater when the asthma is sub-optimally managed and controlled and varies depending on the par. asthma control. Asthma control was assessed using the Asthma Control Questionnaire (ACQ) and par. were asked to recall their experiences during the previous week and respond to the 6 specified questions on a 7-point Likert scale (0=well-controlled; 6=maximum impairment \[poorly controlled\]; a score of ≤0.75 indicates well controlled symptoms. The following parameters were presented: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA). Only 59 par. were active workers. When stratified by asthma control and severity each stratum had a sample less than 59. Although results are presented. data may not be reliable due to the low number of par. in each stratum.

Outcome measures

Outcome measures
Measure
BD-Asthma/RESP
n=52 Participants
Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Well controlled, CPA TCC, n=14
12.65 Canadian Dollars
Standard Deviation 33.74
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL, Partly controlled, CAA, n=9
557.65 Canadian Dollars
Standard Deviation 1380.41
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Partly controlled, CAA, n=10
171.66 Canadian Dollars
Standard Deviation 266.70
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL, Partly controlled, CPA, n=10
57.04 Canadian Dollars
Standard Deviation 168.54
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Partly controlled, CPA, n=10
32.51 Canadian Dollars
Standard Deviation 50.72
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL, Partly controlled, CAA TCC, n=8
585.29 Canadian Dollars
Standard Deviation 1473.06
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Partly controlled, CAA TCC possible, n=10
171.66 Canadian Dollars
Standard Deviation 266.70
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL,Partly controlled, CPA TCC, n=8
71.30 Canadian Dollars
Standard Deviation 188.04
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Partly controlled, CPA TCC, n=10
32.51 Canadian Dollars
Standard Deviation 50.72
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL, Partly controlled, TICA, n=8
656.59 Canadian Dollars
Standard Deviation 1660.30
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Partly controlled, TICA, n=10
204.18 Canadian Dollars
Standard Deviation 296.69
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL, Uncontrolled, CAA, n=21
96.09 Canadian Dollars
Standard Deviation 233.01
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Uncontrolled, CAA, n=15
39.75 Canadian Dollars
Standard Deviation 73.72
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL, Uncontrolled, CPA, n=22
9.20 Canadian Dollars
Standard Deviation 34.71
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Uncontrolled, CPA, n=14
9.34 Canadian Dollars
Standard Deviation 25.80
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL, Uncontrolled, CAA TCC, n=20
100.89 Canadian Dollars
Standard Deviation 238.00
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Uncontrolled, CAA TCC, n=13
45.86 Canadian Dollars
Standard Deviation 77.69
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL, Uncontrolled, CPA TCC, n=20
10.12 Canadian Dollars
Standard Deviation 36.36
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Uncontrolled, CPA TCC, n=10
10.06 Canadian Dollars
Standard Deviation 26.71
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL, Uncontrolled, TICA, n=20
111.01 Canadian Dollars
Standard Deviation 239.72
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Uncontrolled, TICA, n=13
55.92 Canadian Dollars
Standard Deviation 99.75
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL, Well controlled, CAA, n=22
278.92 Canadian Dollars
Standard Deviation 949.43
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Well controlled, CAA, n=15
33.53 Canadian Dollars
Standard Deviation 90.66
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL,Well controlled, CPA, n=18
4.02 Canadian Dollars
Standard Deviation 12.84
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Well controlled, CPA, n=15
11.8 Canadian Dollars
Standard Deviation 32.68
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL,Well controlled, CAA TCC, n=18
96.23 Canadian Dollars
Standard Deviation 251.82
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Well controlled, CAA TCC, n=14
35.92 Canadian Dollars
Standard Deviation 93.59
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL, Well controlled, CPA TCC, n=18
4.02 Canadian Dollars
Standard Deviation 12.84
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
BL,Well controlled, TICA, n=18
100.25 Canadian Dollars
Standard Deviation 263.14
Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
FUP, Well controlled, TICA, n=14
48.57 Canadian Dollars
Standard Deviation 94.44

PRIMARY outcome

Timeframe: BL and 12-month FUP

Population: Source Population. Only participants with available data in each category (represented by n=X in the category title) were analyzed. One third of the participants selected were retired. Only 59 participants were active workers. Therefore the stratification for asthma control and severity included very low numbers (52 at BL; 40 at FUP).

Costs of asthma may vary depending on the participant's asthma severity. Asthma severity was based on the standard definitions for severity and ACQ scores: Mild (\<0.75), Moderate (\>0.75) and Severe (any ACQ score). The following parameters were presented: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA).

Outcome measures

Outcome measures
Measure
BD-Asthma/RESP
n=52 Participants
Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Mild, CAA, n=1
154.36 Canadian Dollars
Standard Deviation 0.00
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Mild, CAA, n=1
303.74 Canadian Dollars
Standard Deviation 0.00
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Mild, CPA, n=1
0.00 Canadian Dollars
Standard Deviation 0.00
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Mild, CPA n=1
0.00 Canadian Dollars
Standard Deviation 0.00
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Mild, CAA TCC, n=1
154.36 Canadian Dollars
Standard Deviation 0
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Mild, CAA TCC, n=1
303.74 Canadian Dollars
Standard Deviation 0
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Mild, TICA, n=1
154.36 Canadian Dollars
Standard Deviation 0.00
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Mild, TICA, n=1
303.74 Canadian Dollars
Standard Deviation 0.00
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Moderate, CAA, n=30
210.09 Canadian Dollars
Standard Deviation 803.66
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Moderate, CAA, n=21
67.75 Canadian Dollars
Standard Deviation 160.89
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Moderate, CPA, n=31
8.32 Canadian Dollars
Standard Deviation 29.80
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Moderate, CPA, n=19
8.62 Canadian Dollars
Standard Deviation 22.19
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Moderate, CAA TCC, n=28
67.81 Canadian Dollars
Standard Deviation 139.95
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Moderate, CAA TCC, n=18
79.05 Canadian Dollars
Standard Deviation 171.85
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Moderate, CPA TCC, n=28
9.21 Canadian Dollars
Standard Deviation 31.28
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Moderate, CPA TCC, n=18
9.10 Canadian Dollars
Standard Deviation 22.72
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Moderate, TICA, n=28
77.0 Canadian Dollars
Standard Deviation 143.12
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Moderate, TICA, n=18
88.14 Canadian Dollars
Standard Deviation 176.35
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Severe, CAA, n=10
553.96 Canadian Dollars
Standard Deviation 1319.40
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Severe, CAA, n=7
103.16 Canadian Dollars
Standard Deviation 229.93
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Severe, CPA, n=9
59.52 Canadian Dollars
Standard Deviation 178.57
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Severe, CPA, n=8
27.99 Canadian Dollars
Standard Deviation 54.90
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Severe, CAA TCC, n=8
650.38 Canadian Dollars
Standard Deviation 1475.45
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Severe, CAA TCC, n=7
103.16 Canadian Dollars
Standard Deviation 229.93
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Severe, CPA TCC, n=8
66.96 Canadian Dollars
Standard Deviation 189.40
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Severe, CPA TCC, n=7
31.99 Canadian Dollars
Standard Deviation 58.03
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
BL, Severe, TICA, n=8
717.35 Canadian Dollars
Standard Deviation 1661.26
Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
FUP, Severe, TICA, n=7
135.16 Canadian Dollars
Standard Deviation 285.08

SECONDARY outcome

Timeframe: At BL, 4-Month, 8-Month and 12-Month FUP

Population: Source Population. Only par. with available data in each category (represented by n=X in the category title) were analyzed. Among the 101 par., 35 (35%) were retired and 59 (58%) were working. Only par. working were who completed the WPAI questionnaire were included in the analysis (56 at BL; 49 at 4 months; 37 at 8 months; 44 at FUP).

WPAI is a self-administered instrument to determine the degree to which asthma affected work productivity while at work and affected activities outside of work in the last 7 days and yields 4 types of scores: Absenteeism (work time missed/missed due to other reasons); Presenteeism (actual time worked); Work Productivity Loss (affected productivity while working); and Activity Impairment (affected regular activities). The following parameters were presented: Hours (Hrs) missed due to asthma (HMA), Hrs missed due to other reasons (HMO), and Hrs actually worked (HAW); all in the last 7 days.

Outcome measures

Outcome measures
Measure
BD-Asthma/RESP
n=56 Participants
Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
BL, HMA, last 7 days, n=56
0.4 Hours
Standard Deviation 2.8
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
4-Month FUP, HMA, last 7 days, n=49
2.4 Hours
Standard Deviation 9.0
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
8-Month FUP, HMA, last 7 days, n=37
0.9 Hours
Standard Deviation 5.3
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
12-Month FUP, HMA, last 7 days, n=44
0.0 Hours
Standard Deviation 0.3
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
BL, HMO, last 7 days, n=56
3.3 Hours
Standard Deviation 9.0
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
4-Month FUP, HMO, last 7 days, n=49
4.2 Hours
Standard Deviation 9.1
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
8-Month FUP, HMO, last 7 days, n=37
6.1 Hours
Standard Deviation 12.8
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
12-Month FUP, HMO, last 7 days, n=44
4.4 Hours
Standard Deviation 10.5
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
BL, HAW, last 7 days, n=56
32.9 Hours
Standard Deviation 13.4
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
4-Month FUP, HAW, last 7 days, n=49
27.6 Hours
Standard Deviation 15.8
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
8-Month FUP, HAW, last 7 days, n=37
28.1 Hours
Standard Deviation 16.0
Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
12-Month FUP, HAW, last 7 days, n=44
33.0 Hours
Standard Deviation 16.6

Adverse Events

BD-Asthma/RESP

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

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

  • Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER