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Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

Primary Purpose

Asthma

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Peripheral exhaled nitric oxide

About this trial

This is an interventional diagnostic trial for Asthma

Eligibility Criteria

4 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Allergy Centre, Tampere University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects with asthma

Arm 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.

Outcomes

Primary Outcome Measures

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

Change in peripheral NO output

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

Change in peripheral airway resistance

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT03718793

First Posted

October 11, 2018

Last Updated

January 3, 2023

Sponsor

Tampere University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03718793

Brief Title

Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

Official Title

Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 15, 2019 (Actual)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All subjects with asthma

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Peripheral exhaled nitric oxide

Other Intervention Name(s)

Impulse oscillometry, ECP/B-eos ratio

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Change in peripheral NO output

Time Frame

Baseline

Title

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

Description

Change in peripheral airway resistance

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

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

Description

ECP/B-Eos ratio will calculated by dividing serum level of ECP by peripheral blood eosinophil count.

Time Frame

Baseline

Title

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

Description

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.

Time Frame

Baseline

Title

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

Description

ECP/B-Eos ratio will be calculated as above. Peripheral airway resistance will be calculated as R5-R20 based on impulse oscillometry.

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lauri Lehtimäki, MD

Phone

+358 40 5562769

lauri.lehtimaki@uta.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Iida Ojaniemi, MD

Phone

+358 45 8774575

iida.ojaniemi@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lauri Lehtimäki, MD

Organizational Affiliation

Tampere University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Allergy Centre, Tampere University Hospital

City

Tampere

ZIP/Postal Code

33521

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lauri Lehtimäki, MD

Phone

+358 405562769

lauri.lehtimaki@gmail.com

First Name & Middle Initial & Last Name & Degree

Iida Ojaniemi, MD

Phone

+358 45 8774575

iida.ojaniemi@gmail.com

First Name & Middle Initial & Last Name & Degree

Iida Ojaniemi, MD

First Name & Middle Initial & Last Name & Degree

Lauri Lehtimäki, MD

First Name & Middle Initial & Last Name & Degree

Jussi Karjalainen, MD

First Name & Middle Initial & Last Name & Degree

Rüdiger Schultz, MD

First Name & Middle Initial & Last Name & Degree

Susanna Salmivesi, MD

First Name & Middle Initial & Last Name & Degree

Antti Tikkakoski, MD

First Name & Middle Initial & Last Name & Degree

Ilkka Junttila, MD

First Name & Middle Initial & Last Name & Degree

Sari Törmänen, MD

First Name & Middle Initial & Last Name & Degree

Juha Kuittinen, MD

First Name & Middle Initial & Last Name & Degree

Kalle Kurppa, MD

12. IPD Sharing Statement

Plan to Share IPD

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Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

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