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GSK Medicine: None
Study Number: 116703
Title: A 3 Month Single Center Randomized Pilot Study to Evaluate the Feasibility and Effectiveness of a Program that
Promotes Wellness by Enhancing Daily Activity in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Rationale: There are very few studies in COPD which have examined programs that assess subject activity with
activity monitors and or pedometers after establishing subject-selected health goals. The purpose of this study is to
determine whether a simple program that incorporates a pedometer along with goal-setting and reinforcement by a life
coach has a measurable and clinically meaningful impact on daily physical activity and quality of life in patients with
COPD.
Phase: IV
Study Period: 08-May-2013 to 24-Sep-2014
Study Design: This was a single-centre, randomized, 3-month, pilot study. Eligible subjects with COPD were
randomized to 1 of 2 possible interventions: a wellness program that incorporated an initial patient consultation, a
pedometer, goal-setting and goal reinforcement or a pedometer only. The study consisted of a 7-10 day period prior to
randomization to establish baseline steps/day followed by a 12 week intervention period.
Centres: Single study site in the U.S.
Indication: Chronic Obstructive Pulmonary Disease
Treatment: There was no study drug intervention in this pilot study. Subjects were randomized to a Wellness program
group (an initial patient consultation, a pedometer, goal-setting and goal reinforcement) or a Pedometer only group.
Objectives: The objective of this study was to evaluate the effectiveness of a program that promotes wellness by
enhancing daily activity level compared with an activity monitor and or pedometer use only in patients with COPD. The
Wellness program incorporated an initial patient consultation, a pedometer, goal-setting and goal reinforcement.
Primary Outcome (Endpoints)/Efficacy: The primary efficacy endpoint was physical activity measured as steps per
day assessed from a pedometer
Secondary Outcome (Endpoints)/Efficacy: Secondary endpoints included the Modified Medical Research Council
(mMRC) dyspnea score, body mass index (BMI), St. George’s Respiratory Questionnaire – Chronic Obstructive
Pulmonary Disorder Questionnaire (SGRQ-C), and COPD Assessment Test (CAT)
Statistical Methods: This was a pilot study and no formal hypothesis was tested. Statistical testing was interpreted
descriptively. The sample size for this pilot study was based on practical considerations. The targeted sample size was
100 randomized subjects completing the study.
The ITT population included all subjects who have been randomized into the study. Intervention group assignment,
wellness program or pedometer only, was based on randomization assignment. The ITT population was the primary
analysis population for summaries and analyses of demographic/background, secondary endpoint and health
outcomes data. It served as a secondary population of interest for the primary endpoint (steps per day). The Completer
population included all subjects in the ITT population who complete the 12-week intervention period and
provided a Week 12 mean steps per day assessment. This population served as the primary analysis population for
the primary endpoint (steps per day) summaries and analyses.
The study was not powered to statistically detect differences in any measure between the Wellness program group
and the pedometer only group. Point estimates and corresponding 95% confidence intervals were constructed for the
differences between the two groups and used to describe these differences. The statistical testing (i.e. confidence
intervals and p-values) were presented for descriptive purposes only. Smoking status (current or former smoker) and
baseline disease severity (Visit 2 post-bronchodilator FEV1 percent predicted) were covariates in the statistical models,
as was the baseline value for the endpoint under study (e.g., baseline steps per day).
Study Population: Eligible subjects were 40 years of age or older with a diagnosis of COPD, a smoking history of
≥10 pack-years, and a pre-bronchodilator FEV1 ≥ 30% - <80% of predicted normal and a pre-bronchodilator FEV1/FVC
(forced vital capacity) ratio of ≤0.7. Eligible subjects must also be taking one or more maintenance respiratory
medications for their COPD (e.g., inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA), tiotropium, or
combinations of these). Any subject who, in the opinion of the investigator, had any other significant respiratory
conditions in addition to COPD were excluded. Subjects were excluded if, in the opinion of the investigator, the subject
had any condition that would have prevented the subject from performing daily activities that were required for the
1
study. Subjects could not have been hospitalized for COPD, pneumonia or any other serious respiratory or cardiac
disorder within 12 weeks prior to Visit 1, and were also excluded if they had experienced ≥3 exacerbations in the
previous year. Subjects participating in a pulmonary rehabilitation (PR) program or who would have started a PR
program during study conduct were also excluded.
Wellness Program
Pedometer Only
Number of Subjects:
Planned, N
115 randomized in order to ensure at least
100 subjects complete
Randomised, N
57
58
Completed, n (%)
52 (91)
56 (97)
Total Number Subjects Withdrawn, N (%)
2 (3)
5 (9)
Withdrawn due to Adverse Events n (%)
0
0
Withdrawn due to Lack of Efficacy n (%)
0
0
Withdrawn for other reasons n (%) )
2
(3)
5 (9)
Demographics
Wellness Program
Pedometer Only
N (ITT)
57
58
Females: Males, n
32:25
35:23
Mean Age, years (SD)
White, n (%)
Primary Efficacy Results:
65.9 (7.55)
54 (93)
65.1 (7.63)
55 (96)
Percent Change from Baseline in Steps per Day at Week 12 (Completer Population)
Wellness Program
Pedometer Only
(n=49)
(n=50)
n
49
50
LS mean change (SE)
36.0 (7.74)
6.0 (8.70)
LS mean change difference
30.0
95% Confidence Interval
(9.9, 50.1)
p-value
0.004
LS = Least squares, SE=Standard error
From an ANCOVA model with terms for intervention group, baseline post-bronchodilator FEV1 percent predicted,
smoking status and baseline value.
LS Mean Differences are calculated as Wellness Program - Pedometer Only.
Secondary Outcome Results:
mMRC Dyspnea Score at Week 12 (ITT Population)
Wellness Program
(N=57)
52
1.6 (0.12)
-0.2 (0.12)
n
LS Mean (SE)
LS Mean Change (SE)
LS Mean Change Difference
95% CI
BMI, kg/m2 at Week 12 (ITT Population)
Pedometer Only
(N=58)
56
1.7 (0.13)
-0.1 (0.13)
-0.1
(-0.4, 0.2)
Wellness Program
Pedometer Only
(N=57)
(N=58)
52
56
29.96 (0.101)
30.20 (0.117)
-0.19 (0.101)
0.05 (0.117)
-0.24
(-0.51, 0.03)
n
LS Mean (SE)
LS Mean Change (SE)
LS Mean Change Difference
95% CI
SGRQ-C Total Score at Week 12 (ITT Population)
Wellness Program
(N=57)
2
Pedometer Only
(N=58)
n
LS Mean (SE)
LS Mean Change (SE)
LS Mean Change Difference
95% CI
CAT at Week 12 (ITT Population)
52
41.10 (1.663)
-0.21 (1.663)
56
41.15 (1.891)
-0.15 (1.891)
-0.06
(-4.33, 4.22)
Wellness Program
(N=57)
52
17.8 (0.82)
1.3 (0.82)
Pedometer Only
(N=58)
56
16.6 (0.95)
0.2 (0.95)
n
LS Mean (SE)
LS Mean Change (SE)
LS Mean Change Difference
1.1
95% CI
(-1.0, 3.2)
BMI=Body mass index; CAT = COPD Assessment Test; LS=Least squares; mMRC=Modified medical research
council; SE=Standard error; SGRQ-C= St. George’s Respiratory Questionnaire – Chronic Obstructive Pulmonary
Disorder Questionnaire
From an ANCOVA model with terms for intervention group, baseline post-bronchodilator FEV1 percent predicted,
smoking status and baseline value.
LS Mean Differences are calculated as Wellness Program - Pedometer Only.
Safety Results: Safety data was not collected in this study.
Conclusion: At Week 12, the Wellness program intervention group demonstrated a 30.0% mean difference in steps
per day compared with the Pedometer-only group. No safety data was collected in this study.
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