Seinäjoki Adult Asthma Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Seinäjoki Adult Asthma Study: A 12-year Real-life Follow-up Study of New-onset Asthma Diagnosed at Adult Age and Treated in Primary and Specialized Care. Finnish Title: Diagnoosista Hoitotasapainoon: Voidaanko Aikuisen Astman Hoitotasapainoa Ennustaa Diagnoosivaiheen löydösten ja Astman Ilmiasun Perusteella?

Conditions
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Asthma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of new-onset asthma made by a respiratory specialist Diagnosis confirmed by at least one of the following objective lung function measurements FEV1 (forced expiratory volume in one second) reversibility in spirometry of at least 15% and 200 ml Diurnal variability (⩾20%) or repeated reversibility (⩾15%/60 l/min) in PEF follow-up A significant decrease in FEV1 (15%) or PEF (20%) in response to exercise or allergen A significant reversibility in FEV1 (at least 15% and 200 ml) or significant mean PEF in response to a trial with oral or inhaled glucocorticoids Symptoms of asthma Age ≥15 years Exclusion Criteria: Physical or mental inability to provide signed informed consent Diagnosis of asthma below the age of 15 years

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control at follow-up visit | Asthma control at follow-up visit according to GINA (Global Initiative for asthma) report 2010. | 12 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 years | 
| Annual number of asthma-related visits to healthcare | All asthma-related visits to healthcare during the follow-up period are recorded. | 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. | 12 years | 
| Annual asthma-related hospitalizations | All asthma-related hospitalizations during the whole follow-up period are recorded. | 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) | 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). | 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). | Diagnosis | 
| Blood eosinophils at diagnostic and follow-up visits | Venous blood is collected and white blood cells including eosinophils counted | 12 years | 
| Blood neutrophils at follow-up visit | Venous blood is collected and white blood cells including neutrophils counted | 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 | 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. | 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. | 12 years | 
| Total Immunoglobulin E (IgE) at diagnosis and follow-up | Total IgE levels as measured by using ImmunoCAP. | 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 | 1 year | 
| Proportion of daily users of inhaled steroids at follow-up visit | Use of inhaled steroids is evaluated based on a structured questionnaire. | 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. | 12 years | 
| Leptin at follow-up visit | Leptin was measured by ELISA at follow-up visit. | 12 years | 
| Adiponectin at follow-up visit | Adiponectin was measured by ELISA at follow-up visit. | 12 years | 
| YKL-40 at follow-up visit | YKL-40 was measured by ELISA at follow-up visit. | 12 years | 
| Pre-bronchodilator FEV1 at follow-up visit | Spirometry was performed according to international recommendations. | 12 years | 
| Post-bronchodilator FEV1 at follow-up visit | Spirometry was performed according to international recommendations. | 12 years | 
| Pre-bronchodilator FEV1/FVC (Forced Vital Capacity) at follow-up visit | Spirometry was performed according to international recommendations. | 12 years | 
| Post-bronchodilator FEV1/FVC at follow-up visit | Spirometry was performed according to international recommendations. | 12 years | 
| Pre-bronchodilator FVC (Forced Vital Capacity) at follow-up visit | Spirometry was performed according to international recommendations. | 12 years | 
| Post-bronchodilator FVC at follow-up visit | Spirometry was performed according to international recommendations. | 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. | 12 years | 
| Rhinitis at follow-up | Allergic or non-allergic rhinitis or persistent rhinitis as evaluated by structured questionnaire. | 12 years | 
| high sensitivity C-reactive protein (hsCRP) concentration at follow-up | hsCRP is measured using particle-enhanced immunoturbidometric method. | 12 years | 
| serum interleukin-6 (IL-6) at follow-up | serum levels of IL-6 are measured by ELISA assay. | 12 years | 
| Quality of life index 15D at baseline and at follow-up | 15D is a validated tool to measure quality of life | 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 | 12 years | 
| Number of other medications | Number of other medications at follow-up visit will be evaluated by structured questionnaire | 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 | 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 | 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 | 2 years | 
| Use of alcohol and coffee at follow-up | Use of alcohol and coffee at follow-up evaluated by using structured questionnaire | 12 years | 
| Daily time spent sitting at follow-up | Daily time spent in sitting position at follow-up evaluated by structured questionnaire | 12 years | 
| Weekly exercise frequency at follow-up | Weekly exercise frequency at follow-up evaluated by structured questionnaire | 12 years | 
| Daily screen time at follow-up | Daily time spent in front of the screen evaluated at follow-up by structured questionnaire | 12 years | 
| Glutamyl transferase at follow-up | Glutamyl transferase at follow-up evaluated by routine standard laboratory methods | 12 years | 
| Carbohydrate-deficient transferrin (CDT) at follow-up | CDT at follow-up measured by using routine standard laboratory methodology | 12 years |