Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
25 participants
OBSERVATIONAL
2024-08-10
2024-12-23
Brief Summary
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Detailed Description
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In general, FEV1 is used to test for airway hyperresponsiveness (AHR), and a 20% decrease after methacholine challenge test (MCT) is considered a positive test.
There is increasing recognition that the small airways are involved in 40-80% of patients with asthma, and the function of these airways is overlooked (the "silent zone") when measuring FEV1, which mainly reflects the function of the central airways.
Small airway dysfunction (SAD) can be assessed by IOS where pressure applied to the airways at a range of frequencies, and components of respiratory resistance and reactance are measured. Resistance at 5 Hz (R5) and 20 Hz (R20), respectively, represent total airway resistance and proximal airway resistance. The difference between these two values can be calculated (R5-R20). High R5-R20 and low reactance at 5 Hz (X5) indicate the presence of SAD.
Knowledge of MCT and IOS is limited. Only three studies have included adult patients, and none of these with healthy controls. These studies have combined IOS and spirometry in the same test, although it is not recommended to perform IOS after a test that requires deep breathing, e.g. FEV1 measurement. Deep breathing is considered to affect the impedance via reduced tone in the smooth muscle.
The investigators have the following objectives for these studies:
1. To determine the IOS response to MCT in healthy adults.
2. To investigate whether spirometry (FEV1) carried out in relation to MCT influences IOS by comparing the IOS response to MCT performed with and without spirometry in healthy adults.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Healthy controls
No lung disease or symptoms. Negative methacholine Challenge Test.
Methacholine Challenge Test
MCT with IOS alone versus MCT IOS and FEV1 combined
Interventions
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Methacholine Challenge Test
MCT with IOS alone versus MCT IOS and FEV1 combined
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* FEV1/FVC-ratio \>0,7
* FeNO \<25 pbb
* Oxygen saturation (SatO2) \>95%
* Negative methacholine Challenge Test = drop in FEV1 less than 20%
Exclusion Criteria
* Lung symptoms
* Medicine for lung disease
* Tobacco smoking
* Ex-smokers with more than 5 package years
* BMI (body mass index) \>40 kg/m2
18 Years
65 Years
ALL
Yes
Sponsors
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Allergi- og Lungeklinikken, Elsinore
NETWORK
Responsible Party
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Thomas Ringbæk
Principal Investigator
Principal Investigators
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Thomas J Ringbæk
Role: PRINCIPAL_INVESTIGATOR
Allergy and Lung Clinic Elsinore
Locations
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Thomas Ringbæk
Elsinore, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Coates AL, Wanger J, Cockcroft DW, Culver BH; Bronchoprovocation Testing Task Force: Kai-Hakon Carlsen; Diamant Z, Gauvreau G, Hall GL, Hallstrand TS, Horvath I, de Jongh FHC, Joos G, Kaminsky DA, Laube BL, Leuppi JD, Sterk PJ. ERS technical standard on bronchial challenge testing: general considerations and performance of methacholine challenge tests. Eur Respir J. 2017 May 1;49(5):1601526. doi: 10.1183/13993003.01526-2016. Print 2017 May.
Cottini M, Lombardi C, Passalacqua G, Bagnasco D, Berti A, Comberiati P, Imeri G, Landi M, Heffler E. Small Airways: The "Silent Zone" of 2021 GINA Report? Front Med (Lausanne). 2022 May 23;9:884679. doi: 10.3389/fmed.2022.884679. eCollection 2022.
Other Identifiers
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Elsinore_Healthy
Identifier Type: -
Identifier Source: org_study_id
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