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?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 259
- 试验地点
- 1
- 主要终点
- Asthma control at follow-up visit
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Physical or mental inability to provide signed informed consent
- •Diagnosis of asthma below the age of 15 years
结局指标
主要结局
Asthma control at follow-up visit
时间窗: 12 years
Asthma control at follow-up visit according to GINA (Global Initiative for asthma) report 2010.
次要结局
- Annual asthma-related hospitalizations(12 years)
- Blood eosinophils at diagnostic and follow-up visits(12 years)
- Pre-bronchodilator FEV1 at follow-up visit(12 years)
- Pre-bronchodilator FEV1/FVC (Forced Vital Capacity) at follow-up visit(12 years)
- Post-bronchodilator FVC at follow-up visit(12 years)
- high sensitivity C-reactive protein (hsCRP) concentration at follow-up(12 years)
- Number of other medications(12 years)
- Annual number of asthma-related visits to healthcare(12 years)
- Annual number of asthma control visits(12 years)
- Fraction of expiratory nitric oxide (FeNO) at follow-up visit(12 years)
- Total Immunoglobulin E (IgE) at diagnosis and follow-up(12 years)
- Leptin at follow-up visit(12 years)
- Number or current and ex-smokers and smoked pack-years at baseline and follow-up(12 years)
- BMI (body-mass index) at baseline and follow-up and BMI change during follow-up(12 years)
- Proportion of patients using at least 2 oral steroid bursts during last 2 years(2 years)
- Daily screen time at follow-up(12 years)
- Proportion of diagnoses of asthma that are based on spirometry(Diagnosis)
- Proportion of users of daily add-on medication at follow-up visit(12 years)
- Adiponectin at follow-up visit(12 years)
- YKL-40 at follow-up visit(12 years)
- Rhinitis at follow-up(12 years)
- Number of co-morbidities at follow-up visit(12 years)
- Glutamyl transferase at follow-up(12 years)
- Quality of life index 15D at baseline and at follow-up(12 years)
- Remission of asthma at follow-up visit(12 years)
- Annual number of asthma exacerbations during follow-up period(12 years)
- Proportion of asthma control visits performed at primary health care(12 years)
- Proportion of diagnoses of asthma that are based on PEF (Peak Expiratory Flow)(Diagnosis)
- Asthma control test (ACT) score at follow-up visit(12 years)
- Annual change in FEV1 during follow-up(1 year)
- Post-bronchodilator FEV1 at follow-up visit(12 years)
- Post-bronchodilator FEV1/FVC at follow-up visit(12 years)
- Pre-bronchodilator FVC (Forced Vital Capacity) at follow-up visit(12 years)
- serum interleukin-6 (IL-6) at follow-up(12 years)
- Daily time spent sitting at follow-up(12 years)
- Carbohydrate-deficient transferrin (CDT) at follow-up(12 years)
- Proportion of daily users of inhaled steroids at follow-up visit(12 years)
- Airways questionnaire 20 (AQ20) score at diagnostic and follow-up visit(12 years)
- Blood neutrophils at follow-up visit(12 years)
- Proportion of patients with asthma-COPD overlap syndrome at follow-up visit(12 years)
- Use of alcohol and coffee at follow-up(12 years)
- Weekly exercise frequency at follow-up(12 years)
研究者
Hannu Kankaanranta
Professor and Head of Respiratory Medicine
Seinajoki Central Hospital