An observational study in Asthma, sponsored by Seinajoki Central Hospital. Completed at 1 site in Finland. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2018-10-26.
Sponsored by Seinajoki Central Hospital · Observational
Seinäjoki Adult Asthma Study is a single-centre 12-year follow-up study of a total cohort of 259 patients having new-onset asthma that was diagnosed at adult age. The study was divided in two parts: the collection of the original cohort (phase I;n=259) and follow-up visit (phase II; n=203). The aim of this study is to increase the understanding on the diagnostics and diagnostic process, organisation of the long-term asthma care, therapeutic outcomes, prognosis and the factors affecting the prognosis of new-onset asthma diagnosed at adult age.
At baseline visit the diagnostic studies performed were: spirometry, PEF (peak expiratory flow) follow-up, other respiratory physiology measurements, laboratory, skin-prick, AQ20 (Airways questionnaire 20), 15D, background data. At follow-up visit, asthma status, co-morbidities (chronic rhinitis or obstructed nose, allergic rhinitis or conjunctivitis, diabetes, hypertension, coronary heart disease, COPD (chronic obstructive pulmonary disease) and any other patient-reported disease), medication (including medication to other diseases and the disease treated), control, severity and lung function were evaluated. In addition to the data gathered at these visits, data on asthma follow-up visits, exacerbations, hospitalisations, possible occupationally induced asthma and prescribed asthma medication were collected from hospital clinics, primary health care, occupational health care and private practices for the whole 12-year follow-up period. In addition, the use of medication that was realised, i.e., medication bought from pharmacy, will be retrieved. In addition to asthma-specific factors, data include occupational, lifestyle and socioeconomic factors at the follow-up visit.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 259 is above the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Seinajoki Central Hospital is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Cohort of 259 patients having new-onset asthma that was diagnosed at adult age. Patients were referred to the hospital by primary-care practitioners because of suspicion of asthma. After 12 years, patients were invited to a follow-up visit. Total of 203 patients returned to follow-up visit.
Diagnosis confirmed by at least one of the following objective lung function measurements
Exclusion Criteria:
Asthma control at follow-up visit
Asthma control at follow-up visit according to GINA (Global Initiative for asthma) report 2010.
Time frame: 12 years
Remission of asthma at follow-up visit
Four different criteria for remission are defined:1) no reported symptoms of asthma in the structured questionnaire, 2) Asthma Control Test (ACT) score of 25, 3) no use of medication for asthma during last 6 months, and 4) no use of oral prednisolone courses during the last 2 years. Further definitions included also normal lung function.
Time frame: 12 years
Annual number of asthma exacerbations during follow-up period
Exacerbations as defined by number of prescriptions of oral steroid courses due to asthma, during the follow-up period.
Time frame: 12 years
Annual number of asthma-related visits to healthcare
All asthma-related visits to healthcare during the follow-up period are recorded.
Time frame: 12 years
Annual number of asthma control visits
All asthma control visits (primary care, specialized care, occupational health care, private health care) during the follow-up period are recorded.
Time frame: 12 years
Annual asthma-related hospitalizations
All asthma-related hospitalizations during the whole follow-up period are recorded.
Time frame: 12 years
Proportion of asthma control visits performed at primary health care
Proportion of asthma control visits performed at primary health care (either physician or nurse)
Time frame: 12 years
Proportion of diagnoses of asthma that are based on spirometry
Proportion of diagnoses that are solely based on spirometry (FEV1 reversibility of at least 15 % and 200 ml or reversibility in response to a trial with oral or inhaled corticosteroids or a significant decrease in FEV1 (15 %) in response to exercise or allergen).
Time frame: Diagnosis
Proportion of diagnoses of asthma that are based on PEF (Peak Expiratory Flow)
Proportion of diagnoses that are solely based on PEF measurement (diurnal variability (≥ 20 %) or repeated reversibility (≥ 15 % / 60 L / min) in PEF-follow-up or significant mean PEF in response to a trial with oral or inhaled glucocorticoids or a significant decrease in PEF (20 %) in response to exercise or allergen).
Time frame: Diagnosis
Blood eosinophils at diagnostic and follow-up visits
Venous blood is collected and white blood cells including eosinophils counted
Time frame: 12 years
Blood neutrophils at follow-up visit
Venous blood is collected and white blood cells including neutrophils counted
Time frame: 12 years
Fraction of expiratory nitric oxide (FeNO) at follow-up visit
Fraction of exhaled nitric oxide (FENO) is measured with a portable rapid-response chemiluminescent analyzer according to ATS (American Thoracic Society) standards
Time frame: 12 years
Airways questionnaire 20 (AQ20) score at diagnostic and follow-up visit
AQ20 is a validated tool to evaluate symptoms of asthma and asthma-related quality of life.
Time frame: 12 years
Asthma control test (ACT) score at follow-up visit
Asthma control test is a validated tool, an international structured questionnaire to evaluate symptoms and control of asthma.
Time frame: 12 years
Total Immunoglobulin E (IgE) at diagnosis and follow-up
Total IgE levels as measured by using ImmunoCAP.
Time frame: 12 years
Annual change in FEV1 during follow-up
Annual change in FEV1 from point of maximal lung function within 2.5 yrs after diagnosis (and start of therapy) to follow-up visit
Time frame: 1 year
Proportion of daily users of inhaled steroids at follow-up visit
Use of inhaled steroids is evaluated based on a structured questionnaire.
Time frame: 12 years
Proportion of users of daily add-on medication at follow-up visit
Use of add-on medication (long-acting beeta2-agonists, leukotriene receptor antagonists, tiotropium or theophylline) is evaluated based on a structured questionnaire.
Time frame: 12 years
Leptin at follow-up visit
Leptin was measured by ELISA at follow-up visit.
Time frame: 12 years
Adiponectin at follow-up visit
Adiponectin was measured by ELISA at follow-up visit.
Time frame: 12 years
YKL-40 at follow-up visit
YKL-40 was measured by ELISA at follow-up visit.
Time frame: 12 years
Pre-bronchodilator FEV1 at follow-up visit
Spirometry was performed according to international recommendations.
Time frame: 12 years
Post-bronchodilator FEV1 at follow-up visit
Spirometry was performed according to international recommendations.
Time frame: 12 years
Pre-bronchodilator FEV1/FVC (Forced Vital Capacity) at follow-up visit
Spirometry was performed according to international recommendations.
Time frame: 12 years
Post-bronchodilator FEV1/FVC at follow-up visit
Spirometry was performed according to international recommendations.
Time frame: 12 years
Pre-bronchodilator FVC (Forced Vital Capacity) at follow-up visit
Spirometry was performed according to international recommendations.
Time frame: 12 years
Post-bronchodilator FVC at follow-up visit
Spirometry was performed according to international recommendations.
Time frame: 12 years
Proportion of patients with asthma-COPD overlap syndrome at follow-up visit
Proportion of patients fulfilling also criteria of COPD: at least 10 smoked pack years and post-FEV1/FVC\<0,7.
Time frame: 12 years
Rhinitis at follow-up
Allergic or non-allergic rhinitis or persistent rhinitis as evaluated by structured questionnaire.
Time frame: 12 years
high sensitivity C-reactive protein (hsCRP) concentration at follow-up
hsCRP is measured using particle-enhanced immunoturbidometric method.
Time frame: 12 years
serum interleukin-6 (IL-6) at follow-up
serum levels of IL-6 are measured by ELISA assay.
Time frame: 12 years
Quality of life index 15D at baseline and at follow-up
15D is a validated tool to measure quality of life
Time frame: 12 years
Number of co-morbidities at follow-up visit
Number and quality of co-morbidities at follow-up visit will be evaluated by using structured questionnaire and from patients records
Time frame: 12 years
Number of other medications
Number of other medications at follow-up visit will be evaluated by structured questionnaire
Time frame: 12 years
Number or current and ex-smokers and smoked pack-years at baseline and follow-up
Number or current and ex-smokers and smoked pack-years at baseline and follow-up will be evaluated by using structured questionnaire
Time frame: 12 years
BMI (body-mass index) at baseline and follow-up and BMI change during follow-up
Weight, height were collected at baseline and at follow-up and BMI calculated
Time frame: 12 years
Proportion of patients using at least 2 oral steroid bursts during last 2 years
Proportion of patients having used at least 2 oral steroid bursts during last 2 years evaluated by using structured questionnaire
Time frame: 2 years
Use of alcohol and coffee at follow-up
Use of alcohol and coffee at follow-up evaluated by using structured questionnaire
Time frame: 12 years
Daily time spent sitting at follow-up
Daily time spent in sitting position at follow-up evaluated by structured questionnaire
Time frame: 12 years
Weekly exercise frequency at follow-up
Weekly exercise frequency at follow-up evaluated by structured questionnaire
Time frame: 12 years
Daily screen time at follow-up
Daily time spent in front of the screen evaluated at follow-up by structured questionnaire
Time frame: 12 years
Glutamyl transferase at follow-up
Glutamyl transferase at follow-up evaluated by routine standard laboratory methods
Time frame: 12 years
Carbohydrate-deficient transferrin (CDT) at follow-up
CDT at follow-up measured by using routine standard laboratory methodology
Time frame: 12 years
Plan to share: No
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Seinajoki Central Hospital