Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

Asthma Clinical Trial

Official title:

Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03718793
• Other study ID #: R17004
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2023
• Source: Tampere University Hospital
• Contact: Lauri Lehtimäki, MD
• Phone: +358 40 5562769
• Email: lauri.lehtimaki[@]uta.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Inflammation

Intervention

Diagnostic Test:
• Peripheral exhaled nitric oxide
Small airway inflammation and dysfunction will be measured using the above mentioned tests.

Locations

Country	Name	City	State
Finland	Allergy Centre, Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of small airway inflammation (measured by peripheral NO output) in untreated asthma	Change in peripheral NO output	Baseline
Primary	Prevalence of small airway dysfunction (measured by peripheral airway resistance) in untreated asthma	Change in peripheral airway resistance	Baseline
Secondary	Difference in Eosinophil Cationic Protein (ECP)/B-Eos ratio between asthmatics and controls	ECP/B-Eos ratio will calculated by dividing serum level of ECP by peripheral blood eosinophil count.	Baseline
Secondary	Correlation between ECP/B-Eos ratio and peripheral NO output in untreated asthma	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.	Baseline
Secondary	Correlation between ECP/B-Eos ratio and peripheral airway resistance in untreated asthma	ECP/B-Eos ratio will be calculated as above. Peripheral airway resistance will be calculated as R5-R20 based on impulse oscillometry.	Baseline