Asthma
Conditions
Brief summary
Small airway inflammation and dysfunction will be measured in 40 children and 40 adults with asthma before and after 8 weeks of treatment with inhaled budesonide. The same measurements will be conducted once in 80 age and sex matched healthy controls.
Interventions
DIAGNOSTIC_TESTPeripheral exhaled nitric oxide
Small airway inflammation and dysfunction will be measured using the above mentioned tests.
Sponsors
Tampere University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* symptoms of asthma and objective evidence of variable or reversible airway obstruction according to at least one of the following criteria * significant response to bronchodilator (in subjects 7 years or older: FEV1 (forced expiratory volume in 1st second) or FVC (forced vital capacity) increases at least 12 % and 200 ml; in 4-6 years old subjects R5 decreases at least 40 %) * in at least 12 years old subjects significant diurnal variation (at least 20 % and 60 l/min on at least three days) or significant response to bronchodilator ( at least 15 % and 60 l/min on at least three occasions) in PEF (peak expiratory flow) during a two-week monitoring * significant airway hyperreactivity (PD20 FEV1 of methacholine less than 600 µg in at least 16 years old subjects, FEV1 decreases at least 15 % in exercise test in 7-15 years old, or R5 increases at least 40 % during free-running test in 4-6 years old subjects)
Exclusion criteria
* current smoking * regular anti-inflammatory asthma medication (will be paused for at least 4 weeks before enrollment) * other chronic pulmonary disease * other diseases that in the opinion of the treating physician prevents participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of small airway inflammation (measured by peripheral NO output) in untreated asthma | Baseline | Change in peripheral NO output |
| Prevalence of small airway dysfunction (measured by peripheral airway resistance) in untreated asthma | Baseline | Change in peripheral airway resistance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Eosinophil Cationic Protein (ECP)/B-Eos ratio between asthmatics and controls | Baseline | ECP/B-Eos ratio will calculated by dividing serum level of ECP by peripheral blood eosinophil count. |
| Correlation between ECP/B-Eos ratio and peripheral NO output in untreated asthma | Baseline | ECP/B-Eos ratio will be calculated as above. Peripheral exhaled NO output will be calculated based on exhaled NO measurement at multiple flow rates. |
| Correlation between ECP/B-Eos ratio and peripheral airway resistance in untreated asthma | Baseline | ECP/B-Eos ratio will be calculated as above. Peripheral airway resistance will be calculated as R5-R20 based on impulse oscillometry. |
Countries
Finland
Contacts
Primary ContactLauri Lehtimäki, MD
Backup ContactIida Ojaniemi, MD
Outcome results
None listed