Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

Tampere University Hospital

Status: Enrolling

Conditions: Asthma

Treatments: Diagnostic Test: Peripheral exhaled nitric oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT03718793

R17004

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 4 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

All subjects with asthma

Experimental group

Description:

In addition to normal diagnostic work out we will measure small airway inflammation based on peripheral exhaled nitric oxide and assess small airway dysfunction using impulse oscillometry. In addition, inflammatory markers in peripheral blood and genotype will be assessed.

Treatment:

Diagnostic Test: Peripheral exhaled nitric oxide