NCT06509659

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

August 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

April 7, 2024

Last Update Submit

September 17, 2024

Conditions

Hyperreactive Airway Disease

Keywords

IOSoscillometryspirometrybronchial hyperreactivity

Outcome Measures

Primary Outcomes (10)

  • Oscillometry; R5

    Resistance at 5 Hz; kPa/L/s with FEV1 measurement

    baseline (carried out with FEV1 measurement)

  • Oscillometry; R5

    Resistance at 5 Hz; kPa/L/s change from baseline

    1-10 days from baseline and carried out without FEV1 measurement

  • Oscillometry; R20

    Resistance at 20 Hz; kPa/l/s with FEV1 measurement

    baseline (carried out without FEV1 measurement)

  • Oscillometry; R20

    Resistance at 20 Hz; kPa/L/s change from baseline

    1-10 days from baseline and carried out without FEV1 measurement

  • Oscillometry; X5

    Reactance at 5 Hz; kPa/l/s with FEV1 measurement

    baseline (carried out without FEV1 measurement)

  • Oscillometry; X5

    Reactance at 5 Hz; kPa/L/s change from baseline

    1-10 days from baseline and carried out without FEV1 measurement

  • Oscillometry; AX

    Area of reactance; kPa/L with FEV1 measurement

    baseline (carried out without FEV1 measurement)

  • Oscillometry; AX

    Area of reactance; kPa/L change from baseline

    1-10 days from baseline and carried out without FEV1 measurement

  • Oscillometry; Fres

    Resonant frequency; Hz with FEV1 measurement

    baseline (carried out without FEV1 measurement)

  • Oscillometry; Fres

    Resonant frequency; Hz change from baseline

    1-10 days from baseline and carried out without FEV1 measurement

Study Arms (1)

Healthy controls

No lung disease or symptoms. Negative methacholine Challenge Test.

Diagnostic Test: Methacholine Challenge Test

Interventions

Methacholine Challenge TestDIAGNOSTIC_TEST

MCT with IOS alone versus MCT IOS and FEV1 combined

Also known as: FEV1 measurement
Healthy controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Ringbæk

Elsinore, 3140, Denmark

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28461290RESULT

  • 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.

    PMID: 35677830RESULT

MeSH Terms

Conditions

Bronchial Hyperreactivity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Thomas J Ringbæk

    Allergy and Lung Clinic Elsinore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Ringbæk, MSci

CONTACT

21969087thomasringbaek@gmail.com

Lars Frolund, MSci

CONTACT

lars.froelund@dadlnet.dk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2024

First Posted

July 19, 2024

Study Start

August 10, 2024

Primary Completion

November 30, 2024

Study Completion

December 23, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)