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Trial details imported from ClinicalTrials.gov

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

Registration number

NCT01254032

Ethics application status

Date submitted

2/12/2010

Date registered

6/12/2010

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]

114169

Universal Trial Number (UTN)

Trial acronym

PACE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pulmonary Disease, Chronic Obstructive

Condition category

Condition code

Respiratory

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]

Incidence of COPD exacerbations over 24 weeks according to the baseline CAT quartiles

Timepoint [1]

24 weeks

Secondary outcome [1]

Incidence of moderate to severe COPD exacerbations over 24 weeks according to the baseline CAT quartiles

Timepoint [1]

24 weeks

Secondary outcome [2]

Time to the first exacerbation according to the baseline CAT quartiles

Timepoint [2]

Secondary outcome [3]

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]

24 weeks

Secondary outcome [4]

Correlation between the CAT scores and FEV1 values

Timepoint [4]

Secondary outcome [5]

Correlation between the CAT scores and MRC dyspnea scores

Timepoint [5]

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?

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

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA

Recruitment hospital [1]

GSK Investigational Site - Concord

Recruitment hospital [2]

GSK Investigational Site - Woolloongabba

Recruitment hospital [3]

GSK Investigational Site - Bedford Park

Recruitment postcode(s) [1]

2137 - Concord

Recruitment postcode(s) [2]

4102 - Woolloongabba

Recruitment postcode(s) [3]

5042 - Bedford Park

Recruitment outside Australia

Country [1]

China

State/province [1]

Guangdong

Country [2]

China

State/province [2]

Hubei

Country [3]

China

State/province [3]

Jiangsu

Country [4]

China

State/province [4]

Liaoning

Country [5]

China

State/province [5]

Beijing

Country [6]

China

State/province [6]

Chongqing

Country [7]

China

State/province [7]

Shanghai

Country [8]

Korea, Republic of

State/province [8]

Seoul

Country [9]

Taiwan

State/province [9]

Changhua

Country [10]

Taiwan

State/province [10]

Kaohsiung

Country [11]

Taiwan

State/province [11]

Taichung

Country [12]

Taiwan

State/province [12]

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/study/NCT01254032

Trial related presentations / publications

Lee SD, Huang MS, Kang J, Lin CH, Park MJ, Oh YM, Kwon N, Jones PW, Sajkov D; Investigators of the Predictive Ability of CAT in Acute Exacerbations of COPD (PACE) Study. The COPD assessment test (CAT) assists prediction of COPD exacerbations in high-risk patients. Respir Med. 2014 Apr;108(4):600-8. doi: 10.1016/j.rmed.2013.12.014. Epub 2014 Jan 6.

Public notes

Contacts

Principal investigator

Name

GSK Clinical Trials

Address

GlaxoSmithKline

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

When will data be available (start and end dates)?

Available to whom?

Available for what types of analyses?

How or where can data be obtained?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01254032

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