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

NCT02073708 | Active Not Recruiting

• 1 other identifier: 1665
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Lung Diseases; Respiratory Symptoms; Inflammation

Outcome Measures

Primary Outcomes (1)

• The occurence of asthma and the association to specific occupational and environmental exposures and comorbidity

  Incidence and associations

  Five years

Secondary Outcomes (2)

• Risk factors for the occurence of asthma symptoms in subjects with asthma symptoms but no asthma diagnosis

  Five years

• 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

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The researchers collected data in 2013 on respiratory symptoms and physician diagnosed asthma from 16.099 inhabitants of Telemark County (the cross-sectional baseline study called The Telemark-study I). A random sample from the baseline study of approximately 650 asthma cases and 650 controls were asked to take part in a medical examination in a case-control study in 2014-15. The five year follow up of the baseline (The Telemark-study II) study was performed in 2018 and included 13500 subjects. The follow-up of the nested case-control study started in September 2018 and is on-going.

You may qualify if:

• Physician diagnosed asthma
• Controls without physician-diagnosed asthma

You may not qualify if:

• inability to fill-inn the questionnaire

Sponsors & Collaborators

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

Study Sites (1)

Telemark Hospital, dep. of Occupational and Environmental Medicine

Skien, Telemark, 3710, Norway

Location

Related Publications (4)

• 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.

  PMID: 23204511 BACKGROUND

• 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.

  PMID: 15828067 BACKGROUND

• 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.

  PMID: 19126585 BACKGROUND

• Fell AKM, Svendsen MV, Kim JL, Abrahamsen R, Henneberger PK, Toren K, Blanc PD, Kongerud J. Exposure to second-hand tobacco smoke and respiratory symptoms in non-smoking adults: cross-sectional data from the general population of Telemark, Norway. BMC Public Health. 2018 Jul 6;18(1):843. doi: 10.1186/s12889-018-5771-4.

  PMID: 29980242 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, citrate plasma, EDTA-plasma, whole blood, gene sequencing (next generation gene sequencing)

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Johny Kongerud, Professor

  Oslo University, Oslo University Hospital

  STUDY DIRECTOR

• Anne Kristin Møller Fell, PhD

  Sykehuset Telemark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 27, 2014
• Study Start: February 1, 2018
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

NO (1)