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
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | BD-Asthma/RESP | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 101 participants | |
53.5 (14.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 101 participants | |
Female |
65 64.4%
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Male |
36 35.6%
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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 |
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Number Analyzed | 101 participants | |
20.7 (16.7) | ||
Control
[1] Mean (Standard Deviation) Unit of measure: ACQ Score |
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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).
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Age of Asthma onset
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 101 participants | |
32.7 (19.1) | ||
FEV1
[1] Mean (Standard Deviation) Unit of measure: Percent predicted |
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Number Analyzed | 101 participants | |
89.3 (23.0) | ||
[1]
Measure Description: Within 90 days of registration date
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FEV1/FVC
[1] Mean (Standard Deviation) Unit of measure: Percent |
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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.
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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 |
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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).
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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 |
Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
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
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
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 |