Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

January 3, 2023 updated by: Lauri Lehtimäki, Tampere University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Recruiting
        • Allergy Centre, Tampere University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Iida Ojaniemi, MD
        • Principal Investigator:
          • Lauri Lehtimäki, MD
        • Sub-Investigator:
          • Jussi Karjalainen, MD
        • Sub-Investigator:
          • Rüdiger Schultz, MD
        • Sub-Investigator:
          • Susanna Salmivesi, MD
        • Sub-Investigator:
          • Antti Tikkakoski, MD
        • Sub-Investigator:
          • Ilkka Junttila, MD
        • Sub-Investigator:
          • Sari Törmänen, MD
        • Sub-Investigator:
          • Juha Kuittinen, MD
        • Sub-Investigator:
          • Kalle Kurppa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All subjects with asthma
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
Small airway inflammation and dysfunction will be measured using the above mentioned tests.
Other Names:
  • Impulse oscillometry
  • ECP/B-eos ratio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of small airway inflammation (measured by peripheral NO output) in untreated asthma
Time Frame: Baseline
Change in peripheral NO output
Baseline
Prevalence of small airway dysfunction (measured by peripheral airway resistance) in untreated asthma
Time Frame: Baseline
Change in peripheral airway resistance
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Eosinophil Cationic Protein (ECP)/B-Eos ratio between asthmatics and controls
Time Frame: Baseline
ECP/B-Eos ratio will calculated by dividing serum level of ECP by peripheral blood eosinophil count.
Baseline
Correlation between ECP/B-Eos ratio and peripheral NO output in untreated asthma
Time Frame: 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.
Baseline
Correlation between ECP/B-Eos ratio and peripheral airway resistance in untreated asthma
Time Frame: Baseline
ECP/B-Eos ratio will be calculated as above. Peripheral airway resistance will be calculated as R5-R20 based on impulse oscillometry.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Lauri Lehtimäki, MD, Tampere university Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2019

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R17004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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