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Seinäjoki Adult Asthma Study (SAAS)

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

Tracking Information
First Submitted Date March 16, 2016
First Posted Date April 11, 2016
Last Update Posted Date October 26, 2018
Study Start Date October 1999
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2016)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 11, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • Annual asthma-related hospitalizations [ Time Frame: 12 years ]
    All asthma-related hospitalizations during the whole follow-up period are recorded.
  • 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)
  • 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).
  • 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).
  • Blood eosinophils at diagnostic and follow-up visits [ Time Frame: 12 years ]
    Venous blood is collected and white blood cells including eosinophils counted
  • Blood neutrophils at follow-up visit [ Time Frame: 12 years ]
    Venous blood is collected and white blood cells including neutrophils counted
  • 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
  • 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.
  • 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.
  • Total Immunoglobulin E (IgE) at diagnosis and follow-up [ Time Frame: 12 years ]
    Total IgE levels as measured by using ImmunoCAP.
  • 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
  • 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.
  • 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.
  • Leptin at follow-up visit [ Time Frame: 12 years ]
    Leptin was measured by ELISA at follow-up visit.
  • Adiponectin at follow-up visit [ Time Frame: 12 years ]
    Adiponectin was measured by ELISA at follow-up visit.
  • YKL-40 at follow-up visit [ Time Frame: 12 years ]
    YKL-40 was measured by ELISA at follow-up visit.
  • Pre-bronchodilator FEV1 at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • Post-bronchodilator FEV1 at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • Pre-bronchodilator FEV1/FVC (Forced Vital Capacity) at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • Post-bronchodilator FEV1/FVC at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • Pre-bronchodilator FVC (Forced Vital Capacity) at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • Post-bronchodilator FVC at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • 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.
  • Rhinitis at follow-up [ Time Frame: 12 years ]
    Allergic or non-allergic rhinitis or persistent rhinitis as evaluated by structured questionnaire.
  • high sensitivity C-reactive protein (hsCRP) concentration at follow-up [ Time Frame: 12 years ]
    hsCRP is measured using particle-enhanced immunoturbidometric method.
  • serum interleukin-6 (IL-6) at follow-up [ Time Frame: 12 years ]
    serum levels of IL-6 are measured by ELISA assay.
  • 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
  • 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
  • Number of other medications [ Time Frame: 12 years ]
    Number of other medications at follow-up visit will be evaluated by structured questionnaire
  • 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
  • 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
  • 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
  • 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
  • Daily time spent sitting at follow-up [ Time Frame: 12 years ]
    Daily time spent in sitting position at follow-up evaluated by structured questionnaire
  • Weekly exercise frequency at follow-up [ Time Frame: 12 years ]
    Weekly exercise frequency at follow-up evaluated by structured questionnaire
  • 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
  • Glutamyl transferase at follow-up [ Time Frame: 12 years ]
    Glutamyl transferase at follow-up evaluated by routine standard laboratory methods
  • Carbohydrate-deficient transferrin (CDT) at follow-up [ Time Frame: 12 years ]
    CDT at follow-up measured by using routine standard laboratory methodology
Original Secondary Outcome Measures
 (submitted: April 4, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • Annual asthma-related hospitalizations [ Time Frame: 12 years ]
    All asthma-related hospitalizations during the whole follow-up period are recorded.
  • 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)
  • 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).
  • 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).
  • Blood eosinophils at diagnostic and follow-up visits [ Time Frame: 12 years ]
    Venous blood is collected and white blood cells including eosinophils counted
  • Blood neutrophils at follow-up visit [ Time Frame: 12 years ]
    Venous blood is collected and white blood cells including neutrophils counted
  • 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
  • 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.
  • 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.
  • Total Immunoglobulin E (IgE) at diagnosis and follow-up [ Time Frame: 12 years ]
    Total IgE levels as measured by using ImmunoCAP.
  • Annual change in FEV1 during follow-up [ Time Frame: 12 years ]
    Annual change in FEV1 from point of maximal lung function within 2.5 yrs after diagnosis (and start of therapy) to follow-up visit
  • 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.
  • 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.
  • Leptin at follow-up visit [ Time Frame: 12 years ]
    Leptin was measured by ELISA at follow-up visit.
  • Adiponectin at follow-up visit [ Time Frame: 12 years ]
    Adiponectin was measured by ELISA at follow-up visit.
  • YKL-40 at follow-up visit [ Time Frame: 12 years ]
    YKL-40 was measured by ELISA at follow-up visit.
  • Pre-bronchodilator FEV1 at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • Post-bronchodilator FEV1 at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • Pre-bronchodilator FEV1/FVC (Forced Vital Capacity) at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • Post-bronchodilator FEV1/FVC at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • Pre-bronchodilator FVC (Forced Vital Capacity) at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • Post-bronchodilator FVC at follow-up visit [ Time Frame: 12 years ]
    Spirometry was performed according to international recommendations.
  • 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.
  • Rhinitis at follow-up [ Time Frame: 12 years ]
    Allergic or non-allergic rhinitis or persistent rhinitis as evaluated by structured questionnaire.
  • high sensitivity C-reactive protein (hsCRP) concentration at follow-up [ Time Frame: 12 years ]
    hsCRP is measured using particle-enhanced immunoturbidometric method.
  • serum interleukin-6 (IL-6) at follow-up [ Time Frame: 12 years ]
    serum levels of IL-6 are measured by ELISA assay.
  • 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
  • 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
  • Number of other medications [ Time Frame: 12 years ]
    Number of other medications at follow-up visit will be evaluated by structured questionnaire
  • 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
  • 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
  • Proportion of patients using at least 2 oral steroid bursts during last 2 years [ Time Frame: 12 years ]
    Proportion of patients having used at least 2 oral steroid bursts during last 2 years evaluated by using structured questionnaire
  • 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
  • Daily time spent sitting at follow-up [ Time Frame: 12 years ]
    Daily time spent in sitting position at follow-up evaluated by structured questionnaire
  • Weekly exercise frequency at follow-up [ Time Frame: 12 years ]
    Weekly exercise frequency at follow-up evaluated by structured questionnaire
  • 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
  • Glutamyl transferase at follow-up [ Time Frame: 12 years ]
    Glutamyl transferase at follow-up evaluated by routine standard laboratory methods
  • Carbohydrate-deficient transferrin (CDT) at follow-up [ Time Frame: 12 years ]
    CDT at follow-up measured by using routine standard laboratory methodology
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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?
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Years
Biospecimen Not Provided
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.
Condition Asthma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 4, 2016)
259
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02733016
Other Study ID Numbers SCH-2000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hannu Kankaanranta, Seinajoki Central Hospital
Study Sponsor Seinajoki Central Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Hannu Kankaanranta, Professor Seinajoki Central Hospital
PRS Account Seinajoki Central Hospital
Verification Date October 2018