A Population-based Investigation of Asthma in the Telemark Region of Norway

Sponsor
Sykehuset Telemark (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02073708
Collaborator
Oslo University Hospital (Other), National Institute for Occupational Safety and Health (NIOSH/CDC) (U.S. Fed), Göteborg University (Other)
2,000
1
214.9
9.3

Study Details

Study Description

Brief Summary

Respiratory conditions impose an enormous burden on the individual and the society. According to the WHO World Health Report 2000, the top five respiratory diseases - including asthma and COPD - account for 17% of all deaths and 13% of all Disability-Adjusted Life Years (DALYs). Obstructive lung diseases are among the most common chronic diseases in working-aged populations affecting ~40 million individuals in Europe. The greatest economic burden of respiratory diseases on health services and lost production in the EU is due to COPD and asthma, at about €20 billion each for healthcare and €25 billion and €15 billion, respectively, for lost production.

For Norway, there are no estimates of asthma prevalence for the country as a whole, but 80/1000 women and 55/1000 men used asthma medication in 2013 according to the national prescription register. Estimated annual deaths in Norway due to COPD were 4070 in 2015, which is 30% higher than for lung cancer. Unfortunately, a substantial proportion of patients are still difficult to treat. This underlines the need for better primary prevention and more knowledge regarding causes and exacerbating factors.

Several risk factors for chronic respiratory diseases are identified, most important tobacco smoke, closely followed by air pollution and occupational exposure. However, according to recent reviews there is a lack of understanding regarding environmental risk factors and mechanisms of how these affect respiratory health, the importance of biological markers and comorbidity, and of socioeconomic risk factors. Moreover, there is a need for assessment of interactions between risk factors and between the individual and the environment.

Telemark has a high proportion of craft- and industrial workers providing exposure contrasts. Furthermore, the use of medication against respiratory diseases and the rate of sick leave are higher in Telemark than elsewhere in Norway. Moreover, the county has a high rate of disability. There are previous studies from other parts of Norway, which have estimated the occurrence of respiratory diseases and provided valuable knowledge regarding some risk factors. However, these studies use crude measures of self-reported exposure and do not provide sufficient information on how to target intervention and implement effective prevention. In contrast to the Telemark study, these studies have not included register data or advanced modelling of environmental exposure.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hypotheses and choice of methods:
    Primary objective:

    To identify preventive and health promoting measures for obstructive respiratory disease in a 5-year follow up of adults from the general population in Telemark.

    Secondary objectives:
    • Identify occupational risk factors for obstructive respiratory disease

    • Assess interactions between risk factors and the individual

    • Transfer relevant knowledge and advice regarding preventive and health promoting measures to individuals, health care professionals and authorities.

    Research problems/questions (Q):

    Q1 What are the emerging occupational risk factors for respiratory health? Q2 What are the social inequity/socioeconomic factors predicting respiratory disease? Q3 How does HRQoL develop over time? Q4 Do risk factors interact and how do they relate to the individual? Q5 What is the population attributable risk (PAR) for the identified risk factors, and what are the key factors for better prevention and respiratory health promotion?

    Choice of methods/work packages (WP) and approaches (A):

    WP I Occupational risk factors Q1 Emerging occupational causes and risk factors for respiratory disease and exacerbation

    • A1.1 Assess associations between self-report of occupational exposure and new-onset and exacerbation of respiratory symptoms and diseases

    • A1.2 Assess associations between job-exposure-matrix data (JEM) and new-onset and exacerbation of respiratory symptoms and diseases

    WP II Individual risk factors Q2 Risk factors for social inequity in respiratory health

    • A2.1 Assessment of the association between socio-demographic variables (gender, age, education, occupation and income) and respiratory health

    WP III Complex interactions Q3 Health related quality of life development over time.

    • A3.1 Impact of respiratory health and disease development and treatment on HRQoL development Q4 Interactions between risk factors and the individual

    • A4.1 Identify interactions between risk factors and the individual by using advanced mathematical modelling Q5 The population attributable risk (PAR) for identified risk factors and key factors for better prevention and respiratory health promotion

    • A5.1 Calculate PAR for risk factors identified in WP1-3 separately and combined

    • A5.2 Based on PAR, estimate key factors for prevention and their cost

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    A Population-based Investigation of Asthma in the Telemark Region of Norway
    Actual Study Start Date :
    Feb 1, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2035
    Anticipated Study Completion Date :
    Dec 31, 2035

    Outcome Measures

    Primary Outcome Measures

    1. The occurence of asthma and the association to specific occupational and environmental exposures and comorbidity [Five years]

      Incidence and associations

    Secondary Outcome Measures

    1. Risk factors for the occurence of asthma symptoms in subjects with asthma symptoms but no asthma diagnosis [Five years]

      Odds ratio

    2. Differences in lung function, FeNO and inflammatory markers in blood in asthma patients and the association of these changes to specific occupational and environmental exposures. [Five years]

      Lung function indices, serum levels in blood

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Physician diagnosed asthma

    • Controls without physician-diagnosed asthma

    Exclusion Criteria:
    • inability to fill-inn the questionnaire

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Telemark Hospital, dep. of Occupational and Environmental Medicine Skien Telemark Norway 3710

    Sponsors and Collaborators

    • Sykehuset Telemark
    • Oslo University Hospital
    • National Institute for Occupational Safety and Health (NIOSH/CDC)
    • Göteborg University

    Investigators

    • Study Director: Johny Kongerud, Professor, Oslo University, Oslo University Hospital
    • Principal Investigator: Anne Kristin Møller Fell, PhD, Sykehuset Telemark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Anne Kristin M. Fell, MD, PhD, Sykehuset Telemark
    ClinicalTrials.gov Identifier:
    NCT02073708
    Other Study ID Numbers:
    • 1665
    First Posted:
    Feb 27, 2014
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2021