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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01254032




Registration number
NCT01254032
Ethics application status
Date submitted
2/12/2010
Date registered
6/12/2010
Date last updated
18/08/2016

Titles & IDs
Public title
Predictive Ability of the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) for Acute Exacerbations (PACE) in Patients With COPD
Scientific title
A 24 Week Study to Evaluate the Predictive Ability of the COPD Assessment Test (CAT) for Acute Exacerbations (PACE) in Patients With Chronic Obstructive Pulmonary Disease
Secondary ID [1] 0 0
114169
Universal Trial Number (UTN)
Trial acronym
PACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of COPD exacerbations over 24 weeks according to the baseline CAT quartiles
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Incidence of moderate to severe COPD exacerbations over 24 weeks according to the baseline CAT quartiles
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Time to the first exacerbation according to the baseline CAT quartiles
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Risk predictors for Incidence of COPD exacerbations over 24 weeks using CAT scores, demographics, MRC scores, lung function parameters, medical history, and therapy history
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Correlation between the CAT scores and FEV1 values
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Correlation between the CAT scores and MRC dyspnea scores
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
1. Type of subject: Outpatients

2. Informed consent: Subjects must give their signed and dated written informed consent
to participate.

3. Gender: Male or Female

4. Age: 40 years of age or older at Visit 1

5. COPD diagnosis: Documented diagnosis of COPD at least 6 months prior to Visit 1 in
accordance with the following definition by the GOLD (Global Initiative for Chronic
Obstructive Lung Disease) guideline: Post bronchodilator FEV1/FVC < 0.7.

6. History of exacerbations: At least one COPD exacerbation which required the use of any
additional treatment in the last 12 months prior to Visit 1.

For subjects who were diagnosed between 6 to 12 months prior to Visit 1, they should
have at least one COPD exacerbation that required the use of any additional treatment
since diagnosis.

7. Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant
during the study

2. Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of
asthma are eligible if COPD is the current diagnosis.

3. Non-compliance: Subjects unable to comply with any aspect of this study protocol or
scheduled visits to the study centre

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Concord
Recruitment hospital [2] 0 0
GSK Investigational Site - Woolloongabba
Recruitment hospital [3] 0 0
GSK Investigational Site - Bedford Park
Recruitment postcode(s) [1] 0 0
2137 - Concord
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Guangdong
Country [2] 0 0
China
State/province [2] 0 0
Hubei
Country [3] 0 0
China
State/province [3] 0 0
Jiangsu
Country [4] 0 0
China
State/province [4] 0 0
Liaoning
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Chongqing
Country [7] 0 0
China
State/province [7] 0 0
Shanghai
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Taiwan
State/province [9] 0 0
Changhua
Country [10] 0 0
Taiwan
State/province [10] 0 0
Kaohsiung
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taichung
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Chronic Obstructive Pulmonary Disease (COPD) is a major health concern, with a substantial
impact on a patient's life. However, the impact of COPD is currently under-recognised and, as
a result, COPD is under-treated. An exacerbation of COPD is a major element that causes poor
quality of life and loss of productivity. Therefore, minimizing the frequency of
exacerbations is a short term treatment goal in COPD management and could improve Quality of
Life (QoL) significantly in all severity groups of COPD.

Although the use of spirometry for the determination of disease severity in COPD is supported
by guidelines, a lung function test alone does not provide a measurement of the overall
impact of COPD on health status and is not generally available especially in primary care
centre. Therefore, a standardised and effective dialogue between patients and physicians in a
consultation could address the impact of COPD on a patient's QoL in this situation.

The COPD Assessment Test (CAT), recently launched in 2009, is a short and simple,
self-administered questionnaire designed to assess the condition of patients and overall
impact of COPD, and to improve patient-physician communication. It has been proven that the
CAT has good repeatability and discriminative properties which suggest that it is sensitive
to treatment effects at a group level. The CAT score with its better ability to assess the
impact of COPD on patients, suggests potential to predict a significant change in COPD status
such as acute exacerbations of COPD.

Since the CAT is designed to assess the impact of COPD on the patient by measuring overall
impairment, it has better correlations with other instruments, such as the Clinical COPD
Questionnaire (CCQ), MRC (Medical Research Council) dyspnoea scale, St George's Respiratory
Questionnaire (SGRQ),and the 6-minute walk test. However, it does not correlate well with
FEV1 (Forced Expiratory Volume in One Second).

While the CAT shares some similarities with other questionnaires, there are several important
differences. For example, the SGRQ is substantially longer than the CAT, is complex to
administer and requires the use of a computer for scoring. The CAT is designed to provide a
holistic measure of the impact of COPD on the patient, whereas the MRC dyspnoea scale only
measures dyspnoea, and the CCQ only assesses clinical disease control. Thus, the CAT is the
only validated, short and simple assessment test which can provide a holistic measure of the
impact of COPD on patients, ensuring both the physicians and the patients gain the
understanding needed to manage COPD optimally.

QoL is defined as an individual's perception of their position in their life in the context
of the culture and value systems. Therefore, the extent of understanding of the questionnaire
might be influenced by language and ethnicities. Since the validation findings so far have
been based on data from the US and Europe, PACE may provide better quality of data across
ethnic groups given that mainly Asian subjects will participate in this study.

PACE is designed to evaluate whether the CAT has a high predictive value in detecting
subsequent exacerbations of COPD. If so, this result might enable both patients and
physicians to better target and optimise management. The primary objective is to evaluate the
predictability of the CAT to have subsequent exacerbations in COPD patients. Secondary
objectives are to evaluate the predictability of the CAT to have moderate to severe
exacerbations or time to the first exacerbation, to identify risk predictors for COPD
exacerbations, and to evaluate correlations between CAT scores and FEV1 values, or MRC
dyspnea scores. An experimental objective is to evaluate the correlation between the CAT
score between 2 consecutive follow-ups (e.g. Week 8 & baseline, Week 16 & Week 8) and a COPD
exacerbation over the following treatment period adjusting for demographics, MRC scores, lung
function parameters, medical history, and therapy history.

PACE is a multicentre, prospective, observational study designed to evaluate the
predictability of the CAT score to have COPD exacerbations over 24 weeks. During the study,
subjects continue taking their regular prescribed treatment. Investigators are free to make
medication adjustments where required. Eligible subjects will have a clinic visit every 8
weeks, during which they will complete the CAT questionnaire, the Exacerbation Check List
(ECL), MRC dyspnea scale, and spirometry. A regular phone call is placed every 8 weeks in
between clinic visits to collect data for the ECL.There is no follow-up period.

550 male and female outpatient subjects will be recruited for PACE to obtain approximately
300 exacerbation events. This study will capture the winter periods in Australia, China,
Korea and Taiwan, when incidence of exacerbations is at its peak.

Statistical analysis will be performed on subjects' data to derive the PACE end-points.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01254032
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01254032