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Completed

NCT Number: NCT02733016

Seinäjoki Adult Asthma Study

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.

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Respiratory Medicine, Seinäjoki Central Hospital

Seinäjoki, 60220, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seinajoki Central Hospital

Other

Registry information

Official study 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?

Acronym: SAAS

Important dates

Study start
1999
Primary completion
2013
First posted
Apr 11, 2016
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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