Seinäjoki Adult Asthma Study (SAAS)

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?

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.

Study Overview

• Status: Completed
• Conditions: Asthma

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 259

Contacts and Locations

Study Locations

• Finland
  • Seinäjoki, Finland, 60220
    • Department of Respiratory Medicine, Seinäjoki Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seinajoki Central Hospital
• Investigators: Principal Investigator: Hannu Kankaanranta, Professor, Seinäjoki Central Hospital

Publications and helpful links

General Publications

• Kankaanranta H, Ilmarinen P, Kankaanranta T, Tuomisto LE. Seinajoki Adult Asthma Study (SAAS): a protocol for a 12-year real-life follow-up study of new-onset asthma diagnosed at adult age and treated in primary and specialised care. NPJ Prim Care Respir Med. 2015 Jun 25;25:15042. doi: 10.1038/npjpcrm.2015.42. No abstract available.
• Ilmarinen P, Tuomisto LE, Kankaanranta H. Phenotypes, Risk Factors, and Mechanisms of Adult-Onset Asthma. Mediators Inflamm. 2015;2015:514868. doi: 10.1155/2015/514868. Epub 2015 Oct 11.
• Tuomisto LE, Ilmarinen P, Kankaanranta H. Prognosis of new-onset asthma diagnosed at adult age. Respir Med. 2015 Aug;109(8):944-54. doi: 10.1016/j.rmed.2015.05.001. Epub 2015 May 21.
• Kankaanranta H, Kauppi P, Tuomisto LE, Ilmarinen P. Emerging Comorbidities in Adult Asthma: Risks, Clinical Associations, and Mechanisms. Mediators Inflamm. 2016;2016:3690628. doi: 10.1155/2016/3690628. Epub 2016 Apr 26.
• Kankaanranta H, Tuomisto LE, Ilmarinen P. Age-specific incidence of new asthma diagnoses in Finland. J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):189-191.e3. doi: 10.1016/j.jaip.2016.08.015. Epub 2016 Oct 17. No abstract available.
• Tuomisto LE, Ilmarinen P, Niemela O, Haanpaa J, Kankaanranta T, Kankaanranta H. A 12-year prognosis of adult-onset asthma: Seinajoki Adult Asthma Study. Respir Med. 2016 Aug;117:223-9. doi: 10.1016/j.rmed.2016.06.017. Epub 2016 Jun 23.
• Ilmarinen P, Tuomisto LE, Niemela O, Danielsson J, Haanpaa J, Kankaanranta T, Kankaanranta H. Comorbidities and elevated IL-6 associate with negative outcome in adult-onset asthma. Eur Respir J. 2016 Oct;48(4):1052-1062. doi: 10.1183/13993003.02198-2015. Epub 2016 Aug 18.
• Tommola M, Ilmarinen P, Tuomisto LE, Haanpaa J, Kankaanranta T, Niemela O, Kankaanranta H. The effect of smoking on lung function: a clinical study of adult-onset asthma. Eur Respir J. 2016 Nov;48(5):1298-1306. doi: 10.1183/13993003.00850-2016. Epub 2016 Sep 22.
• Ilmarinen P, Tuomisto LE, Niemela O, Tommola M, Haanpaa J, Kankaanranta H. Cluster Analysis on Longitudinal Data of Patients with Adult-Onset Asthma. J Allergy Clin Immunol Pract. 2017 Jul-Aug;5(4):967-978.e3. doi: 10.1016/j.jaip.2017.01.027. Epub 2017 Apr 25.
• Tommola M, Ilmarinen P, Tuomisto LE, Lehtimaki L, Haanpaa J, Niemela O, Kankaanranta H. Differences between asthma-COPD overlap syndrome and adult-onset asthma. Eur Respir J. 2017 May 1;49(5):1602383. doi: 10.1183/13993003.02383-2016. Print 2017 May.
• Tommola M, Ilmarinen P, Tuomisto LE, Kankaanranta H. Concern of underdiagnosing asthma-COPD overlap syndrome if age limit of 40 years for asthma is used. Eur Respir J. 2017 Aug 3;50(2):1700871. doi: 10.1183/13993003.00871-2017. Print 2017 Aug. No abstract available.
• Vahatalo I, Ilmarinen P, Tuomisto LE, Niemela O, Kankaanranta H. Inhaled corticosteroids and asthma control in adult-onset asthma: 12-year follow-up study. Respir Med. 2018 Apr;137:70-76. doi: 10.1016/j.rmed.2018.02.025. Epub 2018 Mar 2.
• Ilmarinen P, Tuomisto LE, Niemela O, Kankaanranta H. Prevalence of Patients Eligible for Anti-IL-5 Treatment in a Cohort of Adult-Onset Asthma. J Allergy Clin Immunol Pract. 2019 Jan;7(1):165-174.e4. doi: 10.1016/j.jaip.2018.05.032. Epub 2018 Jun 9.
• Takala J, Vähätalo I, Tuomisto LE, Niemelä O, Ilmarinen P, Kankaanranta H. Participation in scheduled asthma follow-up contacts and adherence to treatment during 12-year follow-up in patients with adult-onset asthma. BMC Pulm Med. 2022 Feb 15;22(1):63. doi: 10.1186/s12890-022-01850-1.
• Ilmarinen P, Vahatalo I, Tuomisto LE, Niemela O, Kankaanranta H. Long-term adherence to inhaled corticosteroids in clinical phenotypes of adult-onset asthma. J Allergy Clin Immunol Pract. 2021 Sep;9(9):3503-3505.e3. doi: 10.1016/j.jaip.2021.04.057. Epub 2021 May 30. No abstract available.
• Ilmarinen P, Pardo A, Tuomisto LE, Vahatalo I, Niemela O, Nieminen P, Kankaanranta H. Long-term prognosis of new adult-onset asthma in obese patients. Eur Respir J. 2021 Apr 1;57(4):2001209. doi: 10.1183/13993003.01209-2020. Print 2021 Apr.
• Tommola M, Won HK, Ilmarinen P, Jung H, Tuomisto LE, Lehtimaki L, Niemela O, Kim TB, Kankaanranta H. Relationship between age and bronchodilator response at diagnosis in adult-onset asthma. Respir Res. 2020 Jul 13;21(1):179. doi: 10.1186/s12931-020-01441-w.
• Ilmarinen P, Juboori H, Tuomisto LE, Niemela O, Sintonen H, Kankaanranta H. Effect of asthma control on general health-related quality of life in patients diagnosed with adult-onset asthma. Sci Rep. 2019 Nov 6;9(1):16107. doi: 10.1038/s41598-019-52361-9.
• Tommola M, Ilmarinen P, Tuomisto LE, Lehtimaki L, Niemela O, Nieminen P, Kankaanranta H. Cumulative effect of smoking on disease burden and multimorbidity in adult-onset asthma. Eur Respir J. 2019 Sep 5;54(3):1801580. doi: 10.1183/13993003.01580-2018. Print 2019 Sep. No abstract available.

Study record dates

Study Major Dates

• Study Start: October 1, 1999
• Primary Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 16, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: SCH-2000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No