Methacholine Challenge Test (MCT) in Healthy Adults

Last updated: September 17, 2024
Sponsor: Allergi- og Lungeklinikken, Elsinore
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Methacholine Challenge Test

Clinical Study ID

NCT06509659
Elsinore_Healthy
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Methacholine Challenge Test
Phase:
Study Start date:
August 10, 2024
Estimated Completion Date:
December 23, 2024

Study 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.

Connect with a study center

  • Thomas Ringbæk

    Helsingør, 3140
    Denmark

    Active - Recruiting

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