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

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ClinicalTrials.gov Identifier: NCT02153346
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : April 24, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Asthma
Interventions Other: Valuation of lost productivity questionnaire
Other: Work productivity and activity impairment questionnaire
Enrollment 101
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title BD-Asthma/RESP
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 101
Completed 90
Not Completed 11
Reason Not Completed
Lost to Follow-up             11
Arm/Group Title BD-Asthma/RESP
Hide Arm/Group Description 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 Number of Baseline Participants 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
53.5  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
65
  64.4%
Male
36
  35.6%
Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants
None 9
High school 27
College 15
University 41
missing 1
Smoking habits  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants
Ex-smokers 44
Current smokers 10
Never smokers 46
missing 1
Number of years with asthma  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
20.7  (16.7)
Control   [1] 
Mean (Standard Deviation)
Unit of measure:  ACQ Score
Number Analyzed 101 participants
1.4  (0.9)
[1]
Measure Description: The Asthma Control Questionnaire (ACQ) is a 7-item questionnaire designed to measure the adequacy of asthma control and the change in asthma control (spontaneous or as a result of treatment). The items score symptoms, FEV1% predicted and daily use of rescue bronchodilator. Each item is scored on a 7 point scale (0=no impairment, 6=maximum impairment). Each item is equally weighted and the total score is the mean of the items (0=totally controlled, 6 severely uncontrolled).
Age of Asthma onset  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
32.7  (19.1)
FEV1   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent predicted
Number Analyzed 101 participants
89.3  (23.0)
[1]
Measure Description: Within 90 days of registration date
FEV1/FVC   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 101 participants
75.1  (9.4)
[1]
Measure Description: FEV1 is defined as forced expiratory volume in 1 second. FVC is defined as Forced vital capacity.
BMI  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants
<18.5 3
18.5-24.9 18
25.0-29.9 38
>=30.0 39
missing 3
Number of years at the HSCM asthma clinic  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
10.4  (9.0)
Asthma severity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants
Mild 1
Moderate 56
Severe 26
missing 18
[1]
Measure Description: Mild asthma (no asthma medication; low daily dose of ICS monotherapy or LTRA, and Asthma Control Questionnaire (ACQ) < 1.5); Moderate asthma (medium to high daily dose of ICS monotherapy or low to medium daily dose of ICS plus LABA or LTRA, and ACQ < 1.5 or low daily dose ICS monotherapy or LTRA monotherapy, and ACQ ≥ 1.5); Severe asthma (high daily dose of ICS with LABA or LTRAs);Very severe asthma (Omalizumab and/or daily use of prednisone).
Employment Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants
Full time 37
Part-time as an employee 13
Self-employed 9
Work disability 6
Unemployed but seeking work 1
Retired 35
1.Primary Outcome
Title Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)
Hide Description 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).
Time Frame BL and at 12-month FUP
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title BD-Asthma/RESP
Hide Arm/Group Description:
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 Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: US Dollars
BL, CAA, n=52 253.3  (847.5)
FUP, CAA, n=40 70.4  (157.6)
BL,CPA,n=50 16.9  (78.8)
FUP,CPA, n=39 17.1  (37.2)
BL,CAA TCC, n=46 183.3  (648.2)
FUP,CAA TCC,n=37 76.10  (162.64)
BL,CPA TCC, n=46 18.4  (82.0)
FUP,CPA TCC,n=37 17.1  (37.20)
BL,TICA,n=46 201.7  (723.7)
FUP, TICA, n=37 93.2  (182.3)
2.Primary Outcome
Title Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP
Hide Description 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.
Time Frame BL and 12-month FUP
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title BD-Asthma/RESP
Hide Arm/Group Description:
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. Only participants actively working who completed the questionnaires were included in the analysis of productivity.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: Canadian Dollars
BL, Partly controlled, CAA, n=9 557.65  (1380.41)
FUP, Partly controlled, CAA, n=10 171.66  (266.70)
BL, Partly controlled, CPA, n=10 57.04  (168.54)
FUP, Partly controlled, CPA, n=10 32.51  (50.72)
BL, Partly controlled, CAA TCC, n=8 585.29  (1473.06)
FUP, Partly controlled, CAA TCC possible, n=10 171.66  (266.70)
BL,Partly controlled, CPA TCC, n=8 71.30  (188.04)
FUP, Partly controlled, CPA TCC, n=10 32.51  (50.72)
BL, Partly controlled, TICA, n=8 656.59  (1660.30)
FUP, Partly controlled, TICA, n=10 204.18  (296.69)
BL, Uncontrolled, CAA, n=21 96.09  (233.01)
FUP, Uncontrolled, CAA, n=15 39.75  (73.72)
BL, Uncontrolled, CPA, n=22 9.20  (34.71)
FUP, Uncontrolled, CPA, n=14 9.34  (25.80)
BL, Uncontrolled, CAA TCC, n=20 100.89  (238.00)
FUP, Uncontrolled, CAA TCC, n=13 45.86  (77.69)
BL, Uncontrolled, CPA TCC, n=20 10.12  (36.36)
FUP, Uncontrolled, CPA TCC, n=10 10.06  (26.71)
BL, Uncontrolled, TICA, n=20 111.01  (239.72)
FUP, Uncontrolled, TICA, n=13 55.92  (99.75)
BL, Well controlled, CAA, n=22 278.92  (949.43)
FUP, Well controlled, CAA, n=15 33.53  (90.66)
BL,Well controlled, CPA, n=18 4.02  (12.84)
FUP, Well controlled, CPA, n=15 11.8  (32.68)
BL,Well controlled, CAA TCC, n=18 96.23  (251.82)
FUP, Well controlled, CAA TCC, n=14 35.92  (93.59)
BL, Well controlled, CPA TCC, n=18 4.02  (12.84)
FUP, Well controlled, CPA TCC, n=14 12.65  (33.74)
BL,Well controlled, TICA, n=18 100.25  (263.14)
FUP, Well controlled, TICA, n=14 48.57  (94.44)
3.Primary Outcome
Title Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP
Hide Description 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).
Time Frame BL and 12-month FUP
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title BD-Asthma/RESP
Hide Arm/Group Description:
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 Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: Canadian Dollars
BL, Mild, CAA, n=1 154.36  (0.00)
FUP, Mild, CAA, n=1 303.74  (0.00)
BL, Mild, CPA, n=1 0.00  (0.00)
FUP, Mild, CPA n=1 0.00  (0.00)
BL, Mild, CAA TCC, n=1 154.36  (0)
FUP, Mild, CAA TCC, n=1 303.74  (0)
BL, Mild, TICA, n=1 154.36  (0.00)
FUP, Mild, TICA, n=1 303.74  (0.00)
BL, Moderate, CAA, n=30 210.09  (803.66)
FUP, Moderate, CAA, n=21 67.75  (160.89)
BL, Moderate, CPA, n=31 8.32  (29.80)
FUP, Moderate, CPA, n=19 8.62  (22.19)
BL, Moderate, CAA TCC, n=28 67.81  (139.95)
FUP, Moderate, CAA TCC, n=18 79.05  (171.85)
BL, Moderate, CPA TCC, n=28 9.21  (31.28)
FUP, Moderate, CPA TCC, n=18 9.10  (22.72)
BL, Moderate, TICA, n=28 77.0  (143.12)
FUP, Moderate, TICA, n=18 88.14  (176.35)
BL, Severe, CAA, n=10 553.96  (1319.40)
FUP, Severe, CAA, n=7 103.16  (229.93)
BL, Severe, CPA, n=9 59.52  (178.57)
FUP, Severe, CPA, n=8 27.99  (54.90)
BL, Severe, CAA TCC, n=8 650.38  (1475.45)
FUP, Severe, CAA TCC, n=7 103.16  (229.93)
BL, Severe, CPA TCC, n=8 66.96  (189.40)
FUP, Severe, CPA TCC, n=7 31.99  (58.03)
BL, Severe, TICA, n=8 717.35  (1661.26)
FUP, Severe, TICA, n=7 135.16  (285.08)
4.Secondary Outcome
Title Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points
Hide Description 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.
Time Frame At BL, 4-Month, 8-Month and 12-Month FUP
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title BD-Asthma/RESP
Hide Arm/Group Description:
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 Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: Hours
BL, HMA, last 7 days, n=56 0.4  (2.8)
4-Month FUP, HMA, last 7 days, n=49 2.4  (9.0)
8-Month FUP, HMA, last 7 days, n=37 0.9  (5.3)
12-Month FUP, HMA, last 7 days, n=44 0.0  (0.3)
BL, HMO, last 7 days, n=56 3.3  (9.0)
4-Month FUP, HMO, last 7 days, n=49 4.2  (9.1)
8-Month FUP, HMO, last 7 days, n=37 6.1  (12.8)
12-Month FUP, HMO, last 7 days, n=44 4.4  (10.5)
BL, HAW, last 7 days, n=56 32.9  (13.4)
4-Month FUP, HAW, last 7 days, n=49 27.6  (15.8)
8-Month FUP, HAW, last 7 days, n=37 28.1  (16.0)
12-Month FUP, HAW, last 7 days, n=44 33.0  (16.6)
Time Frame [Not Specified]
Adverse Event Reporting Description There were no adverse events collected in this study.
 
Arm/Group Title BD-Asthma/RESP
Hide Arm/Group Description 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.
All-Cause Mortality
BD-Asthma/RESP
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
BD-Asthma/RESP
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BD-Asthma/RESP
Affected / at Risk (%)
Total   0/0 
Important limitations regarding sample size,generalizability and results interpretation.Data not reliable due to low numbers by strata. Changes in work status,full/part-time,and treatments or other factors influencing productivity were not accounted.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02153346    
Other Study ID Numbers: 200347
First Submitted: May 22, 2014
First Posted: June 3, 2014
Results First Submitted: December 16, 2016
Results First Posted: April 24, 2017
Last Update Posted: August 17, 2018