Last updated: 11/07/2018 11:11:17

Study of chronic obstructive pulmonary disease (COPD) prevalence in Japanese subjects with smoking history who are aged 40 years or older and consulting periodically for cardiovascular disease

GSK study ID
116883
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Study of chronic obstructive pulmonary disease (COPD) prevalence in Japanese subjects with smoking history who are aged 40 years or older and consulting periodically for cardiovascular disease
Trial description: This study will be conducted as a prospective observational survey by using hand-held spirometer to determine the proportion of Japanese patients being treated for cardiovascular disease who have concurrent COPD and airflow limitation.
This study is cross-national study, including 3 types of cardiovascular physicians based on their COPD diagnosis skill, knowledge and awareness. At least 600 subjects (maximum: 1000 subjects) with cardiovascular diseases will be recruited (at least 200 in each type. Sample size estimation is below). Each subject will be asked to complete a CAT questionnaire and to complete a pulmonary function test using the Hai-checker device. Demography, details of concurrent diseases and medications will be collected. No formal statistical testing is planned in this study which is essentially a survey to assess the rates of COPD.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Pulmonary function test using hand-held spirometer (airflow limitation)

Timeframe: 1 visit

Secondary outcomes:

COPD Assessment test (CAT)

Timeframe: 1 visit

Interventions:
Not applicable
Enrollment:
1001
Primary completion date:
Not applicable
Observational study model:
Case-Only
Time perspective:
Prospective
Clinical publications:
Onishi K, Yoshimoto D, Hagan G and Jones PW .The prevalence of airflow limitation in outpatients with cardiovascular disease in Japan.Int J Chron Obstruct Pulmon Dis.2014;9 :563-568
Yoshimoto D, Nakano Y, Onishi K, Hagan G, Jones P.The relationship between the COPD Assessment Test score and airflow limitation in Japan in patients aged over 40 years with a smoking history.Int J Chron Obstruct Pulmon Dis.2014;9:1357-63
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
December 2012 to January 2013
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
none
  • 1) Japanese males and females
  • 2) Aged 40 years or older at the time of enrolment
  • 1) Difficult to measure spirometry appropriately on the day of study visit due to an acute respiratory infection. (If this occurs subject should return for spirometry when the infection has resolved.)
  • 2) Judged as inappropriate to participate in this study by the investigator or subinvestigator
Inclusion and exclusion criteria
Inclusion criteria:
  • 1) Japanese males and females 2) Aged 40 years or older at the time of enrolment 3) A smoking history of at least 10 pack-years (regardless of present or former smoker) 4) Consulting periodically for circulatory disease (hypertension, major risk factor of ischemic cardiac diseases, will be included when receiving drug therapy for at least one year ) 5) Judged as capable of complying with the protocol by the investigator or subinvestigator 6) Capable of giving written consent
Exclusion criteria:
  • 1) Difficult to measure spirometry appropriately on the day of study visit due to an acute respiratory infection. (If this occurs subject should return for spirometry when the infection has resolved.) 2) Judged as inappropriate to participate in this study by the investigator or subinvestigator

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2013-22-01

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website