Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

NCT03718793 | Unknown

• 1 other identifier: R17004
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Prevalence of small airway inflammation (measured by peripheral NO output) in untreated asthma

  Change in peripheral NO output

  Baseline

• Prevalence of small airway dysfunction (measured by peripheral airway resistance) in untreated asthma

  Change in peripheral airway resistance

  Baseline

Secondary Outcomes (3)

• Difference in Eosinophil Cationic Protein (ECP)/B-Eos ratio between asthmatics and controls

  Baseline

• Correlation between ECP/B-Eos ratio and peripheral NO output in untreated asthma

  Baseline

• Correlation between ECP/B-Eos ratio and peripheral airway resistance in untreated asthma

  Baseline

Study Arms (1)

All subjects with asthma

EXPERIMENTAL

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.

Diagnostic Test: Peripheral exhaled nitric oxide

Interventions

Peripheral exhaled nitric oxide DIAGNOSTIC_TEST

Small airway inflammation and dysfunction will be measured using the above mentioned tests.

Also known as: Impulse oscillometry, ECP/B-eos ratio

All subjects with asthma

Eligibility Criteria

• Age: 4 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Allergy Centre, Tampere University Hospital

Tampere, 33521, Finland

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lauri Lehtimäki, MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauri Lehtimäki, MD

CONTACT

+358 40 5562769; lauri.lehtimaki@uta.fi

Iida Ojaniemi, MD

CONTACT

+358 45 8774575; iida.ojaniemi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 24, 2018
• Study Start: February 15, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)