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Status unknownNCT03718793Updated Jan 4, 2023

Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes

An interventional study of Peripheral exhaled nitric oxide in Asthma, sponsored by Tampere University Hospital. Status unknown at 1 site in Finland. Open to participants aged 4 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by Tampere University Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Not applicable
Ages
4 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma
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In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 160 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • 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

Interventions

  • Diagnostic testPeripheral exhaled nitric oxide

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

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

06

What researchers measure

Primary outcomes

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

    Change in peripheral NO output

    Time frame: Baseline

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

    Change in peripheral airway resistance

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Allergy Centre, Tampere University Hospital
    Tampere, 33521, Finland
    • Lauri Lehtimäki, MD · Contact · lauri.lehtimaki@gmail.com · +358 405562769
    • Iida Ojaniemi, MD · Contact · iida.ojaniemi@gmail.com · +358 45 8774575
    • Iida Ojaniemi, MD · Sub investigator
    • Lauri Lehtimäki, MD · Principal 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 · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03718793
Lead sponsor
Tampere University Hospital
Responsible party
Lauri Lehtimäki (Associate professor, Tampere University Hospital) — Principal investigator
First posted
Oct 24, 2018
Start date
Feb 15, 2019
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Jan 4, 2023

Study contacts

Lauri Lehtimäki, MD
Contact
lauri.lehtimaki@uta.fi
+358 40 5562769
Iida Ojaniemi, MD
Contact
iida.ojaniemi@gmail.com
+358 45 8774575
Lauri Lehtimäki, MD
principal investigator · Tampere University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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