Clinical trial NCT02733016: Seinäjoki Adult Asthma Study
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Seinajoki Central Hospital
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 259
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Asthma control at follow-up visit
timeFrame: 12 years
Secondary outcomes:
measure: Remission of asthma at follow-up visit
timeFrame: 12 years
measure: Annual number of asthma exacerbations during follow-up period
timeFrame: 12 years
measure: Annual number of asthma-related visits to healthcare
timeFrame: 12 years
measure: Annual number of asthma control visits
timeFrame: 12 years
measure: Annual asthma-related hospitalizations
timeFrame: 12 years
measure: Proportion of asthma control visits performed at primary health care
timeFrame: 12 years
measure: Proportion of diagnoses of asthma that are based on spirometry
timeFrame: Diagnosis
measure: Proportion of diagnoses of asthma that are based on PEF (Peak Expiratory Flow)
timeFrame: Diagnosis
measure: Blood eosinophils at diagnostic and follow-up visits
timeFrame: 12 years
measure: Blood neutrophils at follow-up visit
timeFrame: 12 years
measure: Fraction of expiratory nitric oxide (FeNO) at follow-up visit
timeFrame: 12 years
measure: Airways questionnaire 20 (AQ20) score at diagnostic and follow-up visit
timeFrame: 12 years
measure: Asthma control test (ACT) score at follow-up visit
timeFrame: 12 years
measure: Total Immunoglobulin E (IgE) at diagnosis and follow-up
timeFrame: 12 years
measure: Annual change in FEV1 during follow-up
timeFrame: 1 year
measure: Proportion of daily users of inhaled steroids at follow-up visit
timeFrame: 12 years
measure: Proportion of users of daily add-on medication at follow-up visit
timeFrame: 12 years
measure: Leptin at follow-up visit
timeFrame: 12 years
measure: Adiponectin at follow-up visit
timeFrame: 12 years
measure: YKL-40 at follow-up visit
timeFrame: 12 years
measure: Pre-bronchodilator FEV1 at follow-up visit
timeFrame: 12 years
measure: Post-bronchodilator FEV1 at follow-up visit
timeFrame: 12 years
measure: Pre-bronchodilator FEV1/FVC (Forced Vital Capacity) at follow-up visit
timeFrame: 12 years
measure: Post-bronchodilator FEV1/FVC at follow-up visit
timeFrame: 12 years
measure: Pre-bronchodilator FVC (Forced Vital Capacity) at follow-up visit
timeFrame: 12 years
measure: Post-bronchodilator FVC at follow-up visit
timeFrame: 12 years
measure: Proportion of patients with asthma-COPD overlap syndrome at follow-up visit
timeFrame: 12 years
measure: Rhinitis at follow-up
timeFrame: 12 years
measure: high sensitivity C-reactive protein (hsCRP) concentration at follow-up
timeFrame: 12 years
measure: serum interleukin-6 (IL-6) at follow-up
timeFrame: 12 years
measure: Quality of life index 15D at baseline and at follow-up
timeFrame: 12 years
measure: Number of co-morbidities at follow-up visit
timeFrame: 12 years
measure: Number of other medications
timeFrame: 12 years
measure: Number or current and ex-smokers and smoked pack-years at baseline and follow-up
timeFrame: 12 years
measure: BMI (body-mass index) at baseline and follow-up and BMI change during follow-up
timeFrame: 12 years
measure: Proportion of patients using at least 2 oral steroid bursts during last 2 years
timeFrame: 2 years
measure: Use of alcohol and coffee at follow-up
timeFrame: 12 years
measure: Daily time spent sitting at follow-up
timeFrame: 12 years
measure: Weekly exercise frequency at follow-up
timeFrame: 12 years
measure: Daily screen time at follow-up
timeFrame: 12 years
measure: Glutamyl transferase at follow-up
timeFrame: 12 years
measure: Carbohydrate-deficient transferrin (CDT) at follow-up
timeFrame: 12 years
Other outcomes:
Locations:
city: Seinäjoki
country: Finland
facility: Department of Respiratory Medicine, Seinäjoki Central Hospital
Study officials:
affiliation: Seinajoki Central Hospital
name: Hannu Kankaanranta, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.