Obstructive Lung DiseasesNCT02073708
A Population-based Investigation of Asthma in the Telemark Region of Norway
An observational study of Obstructive Lung Diseases and Respiratory Symptoms, run by Sykehuset Telemark at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Obstructive Lung Diseases, Respiratory Symptoms, Inflammation
- How many people
- 2,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2018to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Physician diagnosed asthma
- Controls without physician-diagnosed asthma
Who cannot join
- inability to fill-inn the questionnaire
Trial locations and contacts
1 site in 1 country.
Norway1 site
Telemark Hospital, dep. of Occupational and Environmental Medicine
Skien, Telemark, 3710
About this study
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.
Read more
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.
Read the 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
- Medical subject headings
- Lung Diseases, Obstructive, Signs and Symptoms, Respiratory, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurence of asthma and the association to specific occupational and environmental exposures and comorbidity
Incidence and associations
Measured: Five years
Secondary outcomes (2)
Risk factors for the occurence of asthma symptoms in subjects with asthma symptoms but no asthma diagnosis
Odds ratio
Measured: 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.
Lung function indices, serum levels in blood
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study start1 Feb 2018
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital, National Institute for Occupational Safety and Health (NIOSH/CDC), Göteborg University
- Responsible party
- Principal investigator, Anne Kristin M. Fell, Sykehuset Telemark
- Investigators
- Johny Kongerud, Professor, Study director, Oslo University, Oslo University HospitalAnne Kristin Møller Fell, PhD, Principal investigator, Sykehuset Telemark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073708
- Sponsor's protocol ID
- 1665
- Status last verified
- Nov 2024
- First submitted
- 20 Feb 2014
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23204511de 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.
PubMed 15828067Delclos 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.
PubMed 19126585Fell 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.
PubMed 29980242
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population-based Investigation of Asthma in the Telemark Region of Norway
- ClinicalTrials.gov ID
- NCT02073708
- Acronym / sponsor ID
- 1665
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- Oslo University Hospital, National Institute for Occupational Safety and Health (NIOSH/CDC), Göteborg University
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Physician diagnosed asthma
- Controls without physician-diagnosed asthma
Key exclusion criteria (1 listed)
- inability to fill-inn the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The occurence of asthma and the association to specific occupational and environmental exposures and comorbidity
Time frame: Five years
Incidence and associations
2 secondary outcomes
Risk factors for the occurence of asthma symptoms in subjects with asthma symptoms but no asthma diagnosis
Time frame: 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.
Time frame: Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 23204511Lillienberg 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.
- Background: PubMed 15828067de 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.
- Background: PubMed 19126585Delclos 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.
- Derived from this study: PubMed 29980242Fell 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johny Kongerud, Professor study director
Oslo University, Oslo University Hospital
Anne Kristin Møller Fell, PhD principal investigator
Sykehuset Telemark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Lung Diseases and Respiratory Symptoms, run by Sykehuset Telemark at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurence of asthma and the association to specific occupational and environmental exposures and comorbidity (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02073708, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.