Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

Not Applicable

Recruiting

• Conditions: Asthma
• Interventions: Diagnostic Test: Peripheral exhaled nitric oxide

• Registration Number: NCT03718793
• Lead Sponsor: Tampere University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Study Start: 2019-02-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects with asthma	Peripheral exhaled nitric oxide	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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.

Trial Locations

Locations (1)

Allergy Centre, Tampere University Hospital; 🇫🇮 Tampere, Finland