Methacholine Challenge Test (MCT) in Healthy Adults

NCT ID: NCT06509659

Last Updated: 2024-09-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-10

Study Completion Date

2024-12-23

Brief Summary

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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

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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.

Conditions

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Hyperreactive Airway Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy controls

No lung disease or symptoms. Negative methacholine Challenge Test.

Methacholine Challenge Test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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FEV1 measurement

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergi- og Lungeklinikken, Elsinore

NETWORK

Sponsor Role lead

Responsible Party

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Thomas Ringbæk

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Thomas Ringbæk, MSci

Role: CONTACT

Lars Frolund, MSci

Role: CONTACT

Facility Contacts

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Thomas J Ringbæk, MSci

Role: primary

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.

Reference Type RESULT
PMID: 28461290 (View on PubMed)

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.

Reference Type RESULT
PMID: 35677830 (View on PubMed)

Other Identifiers

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Elsinore_Healthy

Identifier Type: -

Identifier Source: org_study_id

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