Last updated: 03/04/2025 08:50:09

Chronic Obstructive REspiratory diseases in CIS countries (CORE Study). Cross-sectional, multinational, population-based study of the point prevalence of COPD, bronchial asthma and allergic rhinitis with risk factor assessments in adult population of major cities of four Commonwealth of Independent States (CIS) countriesCORE

GSK study ID
116757
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: Chronic Obstructive REspiratory diseases in CIS countries (CORE Study). Cross-sectional, multinational, population-based study of the point prevalence of COPD, bronchial asthma and allergic rhinitis with risk factor assessments in adult population of major cities of four Commonwealth of Independent States (CIS) countries
Trial description: The study is a multinational, cross-sectional study. It will be carried out in four CIS countries across several major cities. The study will estimate the point prevalence of chronic obstructive pulmonary disease, bronchial asthma and allergic rhinitis and will assess risk factors for these health conditions. The data will be collected from 930 participants for each country during household visits in streets, selected according to a stratified random cluster sampling procedure, using the standard ATS respiratory Symptoms Questionnaire, Asthma Control Test™, COPD Assessment Test™, GOLD Screener, mMRC dyspnoea scale, Patient Activation Measure questionnaire, International Physical Activity Questionnaire and confirmed by spirometry.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Point prevalence of COPD, BA and AR in adult population in several major cities of four CIS countries (Ukraine, Kazakhstan, Uzbekistan, and Azerbaijan) based on ATS respiratory symptoms questionnaire and spirometry

Timeframe: Throughout the study

Secondary outcomes:

4. Prevalence of prior diagnosis of airflow limitation or COPD, BA and AR in adult population in several major cities of CIS countries

Timeframe: Throughout the study

3. Association between risk factors (e.g. smoking, occupational contact with dust, open-fire cooking) and current COPD point prevalence in adult population in several major cities of CIS countries

Timeframe: Throughout the study

5. Health status questionnaire scores COPD Assessment test™ (CAT™); GOLD Screener, modified Medical Research Council dyspnoea score, Asthma Control Test™, ATS Respiratory Symptoms Questionnaire in participants with and without diagnosis or symptoms of CO

Timeframe: Throughout the study

1. Point-prevalence of Overweight/Obesity based on BMI in adult population in several major cities of CIS countries.

Timeframe: Throughout the study

Association between physical activity assessed by the International Physical Activity Questionnaire and prevalence of chronic respiratory diseases

Timeframe: Throughout the study

Association between BMI (obesity, overweight, normal weight) and prevalence of chronic respiratory diseases

Timeframe: Throughout the study

Other (non-respiratory) selected co-morbid conditions and associated medications

Timeframe: Throughout the study

Respiratory selected co-morbid conditions and associated medications

Timeframe: Throughout the study

Smoking status and pack-years

Timeframe: Throughout the study

Socioeconomic status; education; marital status; migration

Timeframe: Throughout the study

Association between co-morbidities and chronic respiratory diseases prevalence (e.g. heart disease, depression, alcohol intake)

Timeframe: Throughout the study

2. Point-prevalence of low, moderate and high physical activity assessed by the International Physical Activity Questionnaire in adult population in several major cities of CIS countries

Timeframe: Throughout the study

Interventions:
  • Device: Зost-bronchodilator spirometry
  • Other: Study Questionnaire
  • Device: Pre-bronchodilator spirometry
    • Enrollment:
    0
    Primary completion date:
    2016-12-02
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    Not applicable
    Medical condition
    Respiratory Disorders
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    September 2013 to February 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    yes
    • Inclusion criteria
    • The informed consent for participation in the study has been signed by the participant
    Inclusion and exclusion criteria
    Inclusion criteria:

      Inclusion criteria

      • The informed consent for participation in the study has been signed by the participant
      • The participant’s age from 18 years (inclusive) and above
      • Willing to perform the spirometry and answer to the study questionnaire
      • ≥10 year of residence in selected city according to confirmation provided by participant Exclusion criteria
      • Any contraindication for lung function test, listed in the Appendix 1 (Section 9.1 of this study protocol), which may have potential harm to participant based on a judgement of Investigator
      • Age < 18 years old
      • Duration of permanent residence in selected study city < 10 years
      • Inability to perform the spirometry or respond to questionnaires
      • Known hypersensitivity or contraindications to bronchodilator (salbutamol)
      • Subjects with a pre-existing condition which, in the opinion of the investigator, would compromise the safety of the subject in this study.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    2016-12-02
    Actual study completion date
    2016-12-02

    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