Skip to content

Methacholine Challenge Test (MCT) in Healthy Adults

Methacholine Challenge Test (MCT) in Healthy Adults: Oscillometry Measured Alone Compared to Oscillometry and FEV1 During the Same Test

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06509659
Enrollment
25
Registered
2024-07-19
Start date
2024-08-10
Completion date
2024-12-23
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperreactive Airway Disease

Keywords

IOS, oscillometry, spirometry, bronchial hyperreactivity

Brief summary

Knowledge of Methacholine Challenge Test (MCT) and impedance Oscillometry (IOS) is limited. Only three studies have included adult patients, and none of these with healthy controls. The three 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.

Detailed description

Asthma is a common chronic disease that is characterized by a history of variable respiratory symptoms and variable expiratory airflow limitation, and usually associated with airway hyperresponsiveness. 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.

Interventions

MCT with IOS alone versus MCT IOS and FEV1 combined

Sponsors

Allergi- og Lungeklinikken, Elsinore
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Forced expiratory volume in the 1. second (FEV1) \>80% * FEV1/FVC-ratio \>0,7 * FeNO \<25 pbb * Oxygen saturation (SatO2) \>95% * Negative methacholine Challenge Test = drop in FEV1 less than 20%

Exclusion criteria

* Any lung disease * Lung symptoms * Medicine for lung disease * Tobacco smoking * Ex-smokers with more than 5 package years * BMI (body mass index) \>40 kg/m2

Design outcomes

Primary

MeasureTime frameDescription
Oscillometry; R5baseline (carried out with FEV1 measurement)Resistance at 5 Hz; kPa/L/s with FEV1 measurement
Oscillometry; R20baseline (carried out without FEV1 measurement)Resistance at 20 Hz; kPa/l/s with FEV1 measurement
Oscillometry; X5baseline (carried out without FEV1 measurement)Reactance at 5 Hz; kPa/l/s with FEV1 measurement
Oscillometry; AXbaseline (carried out without FEV1 measurement)Area of reactance; kPa/L with FEV1 measurement
Oscillometry; Fresbaseline (carried out without FEV1 measurement)Resonant frequency; Hz with FEV1 measurement

Countries

Denmark

Contacts

Primary ContactThomas Ringbæk, MSci
thomasringbaek@gmail.com21969087
Backup ContactLars Frolund, MSci
lars.froelund@dadlnet.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026