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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02073708
• Other study ID #: 1665
• Status: Active, not recruiting
• Start date: February 1, 2018
• Est. completion date: December 31, 2035

Study information

• Verified date: November 2023
• Source: Sykehuset Telemark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Physician diagnosed asthma

• Controls without physician-diagnosed asthma

Exclusion Criteria:

• inability to fill-inn the questionnaire

Related Conditions & MeSH terms

• Inflammation
• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Lung Diseases
• Respiratory Symptoms
• Signs and Symptoms, Respiratory

Locations

Country	Name	City	State
Norway	Telemark Hospital, dep. of Occupational and Environmental Medicine	Skien	Telemark

Sponsors (4)

Lead Sponsor	Collaborator
Sykehuset Telemark	Göteborg University, National Institute for Occupational Safety and Health (NIOSH/CDC), Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

de Vocht F, Zock JP, Kromhout H, Sunyer J, Anto JM, Burney P, Kogevinas M. Comparison of self-reported occupational exposure with a job exposure matrix in an international community-based study on asthma. Am J Ind Med. 2005 May;47(5):434-42. doi: 10.1002/ajim.20154. — View Citation

Delclos GL, Gimeno D, Arif AA, Benavides FG, Zock JP. Occupational exposures and asthma in health-care workers: comparison of self-reports with a workplace-specific job exposure matrix. Am J Epidemiol. 2009 Mar 1;169(5):581-7. doi: 10.1093/aje/kwn387. Epub 2009 Jan 6. — View Citation

Lillienberg L, Andersson E, Janson C, Dahlman-Hoglund A, Forsberg B, Holm M, Glslason T, Jogi R, Omenaas E, Schlunssen V, Sigsgaard T, Svanes C, Toren K. Occupational exposure and new-onset asthma in a population-based study in Northern Europe (RHINE). Ann Occup Hyg. 2013 May;57(4):482-92. doi: 10.1093/annhyg/mes083. Epub 2012 Dec 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurence of asthma and the association to specific occupational and environmental exposures and comorbidity	Incidence and associations	Five years
Secondary	Risk factors for the occurence of asthma symptoms in subjects with asthma symptoms but no asthma diagnosis	Odds ratio	Five years
Secondary	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.	Lung function indices, serum levels in blood	Five years