Seinäjoki Adult Asthma Study

Asthma Clinical Trial

— SAAS  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733016
• Other study ID #: SCH-2000
• Status: Completed
• Start date: October 1999

Study information

• Verified date: October 2018
• Source: Seinajoki Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Finland	Department of Respiratory Medicine, Seinäjoki Central Hospital	Seinäjoki

Sponsors (1)

Lead Sponsor	Collaborator
Seinajoki Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (13)

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. Review. — View Citation

Ilmarinen P, Tuomisto LE, Niemelä O, Danielsson J, Haanpää 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. — View Citation

Ilmarinen P, Tuomisto LE, Niemelä O, Kankaanranta H. Prevalence of Patients Eligible for Anti-IL-5 Treatment in a Cohort of Adult-Onset Asthma. J Allergy Clin Immunol Pract. 2018 Jun 9. pii: S2213-2198(18)30388-X. doi: 10.1016/j.jaip.2018.05.032. [Epub ah — View Citation

Ilmarinen P, Tuomisto LE, Niemelä O, Tommola M, Haanpää 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 — View Citation

Kankaanranta H, Ilmarinen P, Kankaanranta T, Tuomisto LE. Seinäjoki 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. — View 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. Review. — View 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. — View Citation

Tommola M, Ilmarinen P, Tuomisto LE, Haanpää J, Kankaanranta T, Niemelä 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 — View 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). pii: 1700871. doi: 10.1183/13993003.00871-2017. Print 2017 Aug. — View Citation

Tommola M, Ilmarinen P, Tuomisto LE, Lehtimäki L, Haanpää J, Niemelä O, Kankaanranta H. Differences between asthma-COPD overlap syndrome and adult-onset asthma. Eur Respir J. 2017 May 1;49(5). pii: 1602383. doi: 10.1183/13993003.02383-2016. Print 2017 May — View 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. Review. — View Citation

Tuomisto LE, Ilmarinen P, Niemelä O, Haanpää J, Kankaanranta T, Kankaanranta H. A 12-year prognosis of adult-onset asthma: Seinäjoki Adult Asthma Study. Respir Med. 2016 Aug;117:223-9. doi: 10.1016/j.rmed.2016.06.017. Epub 2016 Jun 23. — View Citation

Vähätalo I, Ilmarinen P, Tuomisto LE, Niemelä 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control at follow-up visit	Asthma control at follow-up visit according to GINA (Global Initiative for asthma) report 2010.	12 years
Secondary	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
Secondary	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
Secondary	Annual number of asthma-related visits to healthcare	All asthma-related visits to healthcare during the follow-up period are recorded.	12 years
Secondary	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
Secondary	Annual asthma-related hospitalizations	All asthma-related hospitalizations during the whole follow-up period are recorded.	12 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood eosinophils at diagnostic and follow-up visits	Venous blood is collected and white blood cells including eosinophils counted	12 years
Secondary	Blood neutrophils at follow-up visit	Venous blood is collected and white blood cells including neutrophils counted	12 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Total Immunoglobulin E (IgE) at diagnosis and follow-up	Total IgE levels as measured by using ImmunoCAP.	12 years
Secondary	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
Secondary	Proportion of daily users of inhaled steroids at follow-up visit	Use of inhaled steroids is evaluated based on a structured questionnaire.	12 years
Secondary	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
Secondary	Leptin at follow-up visit	Leptin was measured by ELISA at follow-up visit.	12 years
Secondary	Adiponectin at follow-up visit	Adiponectin was measured by ELISA at follow-up visit.	12 years
Secondary	YKL-40 at follow-up visit	YKL-40 was measured by ELISA at follow-up visit.	12 years
Secondary	Pre-bronchodilator FEV1 at follow-up visit	Spirometry was performed according to international recommendations.	12 years
Secondary	Post-bronchodilator FEV1 at follow-up visit	Spirometry was performed according to international recommendations.	12 years
Secondary	Pre-bronchodilator FEV1/FVC (Forced Vital Capacity) at follow-up visit	Spirometry was performed according to international recommendations.	12 years
Secondary	Post-bronchodilator FEV1/FVC at follow-up visit	Spirometry was performed according to international recommendations.	12 years
Secondary	Pre-bronchodilator FVC (Forced Vital Capacity) at follow-up visit	Spirometry was performed according to international recommendations.	12 years
Secondary	Post-bronchodilator FVC at follow-up visit	Spirometry was performed according to international recommendations.	12 years
Secondary	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
Secondary	Rhinitis at follow-up	Allergic or non-allergic rhinitis or persistent rhinitis as evaluated by structured questionnaire.	12 years
Secondary	high sensitivity C-reactive protein (hsCRP) concentration at follow-up	hsCRP is measured using particle-enhanced immunoturbidometric method.	12 years
Secondary	serum interleukin-6 (IL-6) at follow-up	serum levels of IL-6 are measured by ELISA assay.	12 years
Secondary	Quality of life index 15D at baseline and at follow-up	15D is a validated tool to measure quality of life	12 years
Secondary	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
Secondary	Number of other medications	Number of other medications at follow-up visit will be evaluated by structured questionnaire	12 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Use of alcohol and coffee at follow-up	Use of alcohol and coffee at follow-up evaluated by using structured questionnaire	12 years
Secondary	Daily time spent sitting at follow-up	Daily time spent in sitting position at follow-up evaluated by structured questionnaire	12 years
Secondary	Weekly exercise frequency at follow-up	Weekly exercise frequency at follow-up evaluated by structured questionnaire	12 years
Secondary	Daily screen time at follow-up	Daily time spent in front of the screen evaluated at follow-up by structured questionnaire	12 years
Secondary	Glutamyl transferase at follow-up	Glutamyl transferase at follow-up evaluated by routine standard laboratory methods	12 years
Secondary	Carbohydrate-deficient transferrin (CDT) at follow-up	CDT at follow-up measured by using routine standard laboratory methodology	12 years