Seinäjoki Adult Asthma Study (SAAS)

• ClinicalTrials.gov Identifier: NCT02733016
• Recruitment Status: Completed
• First Posted: April 11, 2016
• Last Update Posted: October 26, 2018
• Sponsor: Seinajoki Central Hospital
• Information provided by (Responsible Party): Hannu Kankaanranta, Seinajoki Central Hospital

Study Description

Brief Summary:

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.

Condition or disease
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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 259 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 12 Years
• Official Title: 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?
• Study Start Date: October 1999
• Actual Primary Completion Date: October 2013

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Asthma control at follow-up visit [ Time Frame: 12 years ]
   Asthma control at follow-up visit according to GINA (Global Initiative for asthma) report 2010.

Secondary Outcome Measures :

1. Remission of asthma at follow-up visit [ Time Frame: 12 years ]
   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.
2. Annual number of asthma exacerbations during follow-up period [ Time Frame: 12 years ]
   Exacerbations as defined by number of prescriptions of oral steroid courses due to asthma, during the follow-up period.
3. Annual number of asthma-related visits to healthcare [ Time Frame: 12 years ]
   All asthma-related visits to healthcare during the follow-up period are recorded.
4. Annual number of asthma control visits [ Time Frame: 12 years ]
   All asthma control visits (primary care, specialized care, occupational health care, private health care) during the follow-up period are recorded.
5. Annual asthma-related hospitalizations [ Time Frame: 12 years ]
   All asthma-related hospitalizations during the whole follow-up period are recorded.
6. Proportion of asthma control visits performed at primary health care [ Time Frame: 12 years ]
   Proportion of asthma control visits performed at primary health care (either physician or nurse)
7. Proportion of diagnoses of asthma that are based on spirometry [ Time Frame: Diagnosis ]
   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).
8. Proportion of diagnoses of asthma that are based on PEF (Peak Expiratory Flow) [ Time Frame: Diagnosis ]
   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).
9. Blood eosinophils at diagnostic and follow-up visits [ Time Frame: 12 years ]
   Venous blood is collected and white blood cells including eosinophils counted
10. Blood neutrophils at follow-up visit [ Time Frame: 12 years ]
    Venous blood is collected and white blood cells including neutrophils counted
11. Fraction of expiratory nitric oxide (FeNO) at follow-up visit [ Time Frame: 12 years ]
    Fraction of exhaled nitric oxide (FENO) is measured with a portable rapid-response chemiluminescent analyzer according to ATS (American Thoracic Society) standards
12. Airways questionnaire 20 (AQ20) score at diagnostic and follow-up visit [ Time Frame: 12 years ]
    AQ20 is a validated tool to evaluate symptoms of asthma and asthma-related quality of life.
13. Asthma control test (ACT) score at follow-up visit [ Time Frame: 12 years ]
    Asthma control test is a validated tool, an international structured questionnaire to evaluate symptoms and control of asthma.
14. Total Immunoglobulin E (IgE) at diagnosis and follow-up [ Time Frame: 12 years ]
    Total IgE levels as measured by using ImmunoCAP.
15. Annual change in FEV1 during follow-up [ Time Frame: 1 year ]
    Annual change in FEV1 from point of maximal lung function within 2.5 yrs after diagnosis (and start of therapy) to follow-up visit
16. Proportion of daily users of inhaled steroids at follow-up visit [ Time Frame: 12 years ]
    Use of inhaled steroids is evaluated based on a structured questionnaire.
17. Proportion of users of daily add-on medication at follow-up visit [ Time Frame: 12 years ]
    Use of add-on medication (long-acting beeta2-agonists, leukotriene receptor antagonists, tiotropium or theophylline) is evaluated based on a structured questionnaire.
18. Leptin at follow-up visit [ Time Frame: 12 years ]
    Leptin was measured by ELISA at follow-up visit.
19. Adiponectin at follow-up visit [ Time Frame: 12 years ]
    Adiponectin was measured by ELISA at follow-up visit.
20. YKL-40 at follow-up visit [ Time Frame: 12 years ]
    YKL-40 was measured by ELISA at follow-up visit.
21. Pre-bronchodilator FEV1 at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
22. Post-bronchodilator FEV1 at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
23. Pre-bronchodilator FEV1/FVC (Forced Vital Capacity) at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
24. Post-bronchodilator FEV1/FVC at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
25. Pre-bronchodilator FVC (Forced Vital Capacity) at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
26. Post-bronchodilator FVC at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
27. Proportion of patients with asthma-COPD overlap syndrome at follow-up visit [ Time Frame: 12 years ]
    Proportion of patients fulfilling also criteria of COPD: at least 10 smoked pack years and post-FEV1/FVC<0,7.
28. Rhinitis at follow-up [ Time Frame: 12 years ]
    Allergic or non-allergic rhinitis or persistent rhinitis as evaluated by structured questionnaire.
29. high sensitivity C-reactive protein (hsCRP) concentration at follow-up [ Time Frame: 12 years ]
    hsCRP is measured using particle-enhanced immunoturbidometric method.
30. serum interleukin-6 (IL-6) at follow-up [ Time Frame: 12 years ]
    serum levels of IL-6 are measured by ELISA assay.
31. Quality of life index 15D at baseline and at follow-up [ Time Frame: 12 years ]
    15D is a validated tool to measure quality of life
32. Number of co-morbidities at follow-up visit [ Time Frame: 12 years ]
    Number and quality of co-morbidities at follow-up visit will be evaluated by using structured questionnaire and from patients records
33. Number of other medications [ Time Frame: 12 years ]
    Number of other medications at follow-up visit will be evaluated by structured questionnaire
34. Number or current and ex-smokers and smoked pack-years at baseline and follow-up [ Time Frame: 12 years ]
    Number or current and ex-smokers and smoked pack-years at baseline and follow-up will be evaluated by using structured questionnaire
35. BMI (body-mass index) at baseline and follow-up and BMI change during follow-up [ Time Frame: 12 years ]
    Weight, height were collected at baseline and at follow-up and BMI calculated
36. Proportion of patients using at least 2 oral steroid bursts during last 2 years [ Time Frame: 2 years ]
    Proportion of patients having used at least 2 oral steroid bursts during last 2 years evaluated by using structured questionnaire
37. Use of alcohol and coffee at follow-up [ Time Frame: 12 years ]
    Use of alcohol and coffee at follow-up evaluated by using structured questionnaire
38. Daily time spent sitting at follow-up [ Time Frame: 12 years ]
    Daily time spent in sitting position at follow-up evaluated by structured questionnaire
39. Weekly exercise frequency at follow-up [ Time Frame: 12 years ]
    Weekly exercise frequency at follow-up evaluated by structured questionnaire
40. Daily screen time at follow-up [ Time Frame: 12 years ]
    Daily time spent in front of the screen evaluated at follow-up by structured questionnaire
41. Glutamyl transferase at follow-up [ Time Frame: 12 years ]
    Glutamyl transferase at follow-up evaluated by routine standard laboratory methods
42. Carbohydrate-deficient transferrin (CDT) at follow-up [ Time Frame: 12 years ]
    CDT at follow-up measured by using routine standard laboratory methodology

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Locations

Finland

Department of Respiratory Medicine, Seinäjoki Central Hospital

Seinäjoki, Finland, 60220

Sponsors and Collaborators

Seinajoki Central Hospital

Investigators

• Principal Investigator: Hannu Kankaanranta, Professor; Seinajoki Central Hospital

More Information

Additional Information:

Publications of Results:

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.

Other 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Takala J, Vahatalo I, Tuomisto LE, Niemela 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.

• Responsible Party: Hannu Kankaanranta, Professor and Head of Respiratory Medicine, Seinajoki Central Hospital
• ClinicalTrials.gov Identifier: NCT02733016
• Other Study ID Numbers: SCH-2000
• First Posted: April 11, 2016
• Last Update Posted: October 26, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases