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Predictive Ability of the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) for Acute Exacerbations (PACE) in Patients With COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01254032
First received: December 2, 2010
Last updated: June 12, 2013
Last verified: May 2012
  Purpose

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.


Condition
Pulmonary Disease, Chronic Obstructive

Study Type: Observational
Study Design: Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence of COPD exacerbations over 24 weeks according to the baseline CAT quartiles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of moderate to severe COPD exacerbations over 24 weeks according to the baseline CAT quartiles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to the first exacerbation according to the baseline CAT quartiles [ Designated as safety issue: No ]
  • Risk predictors for Incidence of COPD exacerbations over 24 weeks using CAT scores, demographics, MRC scores, lung function parameters, medical history, and therapy history [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Correlation between the CAT scores and FEV1 values [ Designated as safety issue: No ]
  • Correlation between the CAT scores and MRC dyspnea scores [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: August 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Approximately 550 male and female outpatient subjects will be enrolled in order to have approximately 300 exacerbation events. Approximately 15 centres in Korea, China, Australia, and Taiwan will be required to recruit the subjects.

Country Planned Number of Subjects Korea 170 China 150 Taiwan 130 Australia 100

Criteria

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254032

Locations
Australia, South Australia
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
China, Guangdong
GSK Investigational Site
Guangzhou, Guangdong, China, 510080
China, Liaoning
GSK Investigational Site
Shenyang, Liaoning, China, 110001
China
GSK Investigational Site
Beijing, China, 100730
GSK Investigational Site
Chongqing, China, 400038
GSK Investigational Site
Shanghai, China, 200003
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
GSK Investigational Site
Seoul, Korea, Republic of, 134-090
GSK Investigational Site
Seoul, Korea, Republic of, 134-701
GSK Investigational Site
Seoul, Korea, Republic of, 100-032
Taiwan
GSK Investigational Site
Changhua, Taiwan, 500
GSK Investigational Site
Kaohsiung, Taiwan, 807
GSK Investigational Site
Taichung, Taiwan, 404
GSK Investigational Site
Taipei City, Taiwan, 100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01254032     History of Changes
Other Study ID Numbers: 114169
Study First Received: December 2, 2010
Last Updated: June 12, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by GlaxoSmithKline:
CAT
COPD

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014