Hyperreactive Airway DiseaseNCT06509659
Methacholine Challenge Test (MCT) in Healthy Adults
An observational study of Hyperreactive Airway Disease, run by Allergi- og Lungeklinikken, Elsinore at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperreactive Airway Disease
- What is being tested?
- Methacholine Challenge Test
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Aug 2024to 23 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Lars Frolund, MSci contact
Denmark1 site, 1 recruiting
- Recruiting
Thomas Ringbæk
Elsinore, 3140
Thomas J Ringbæk, MSci, 21969087, thomasringbaek@gmail.com
About this study
Official title: Methacholine Challenge Test (MCT) in Healthy Adults: Oscillometry Measured Alone Compared to Oscillometry and FEV1 During the Same Test
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.
Read the 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:
- To determine the IOS response to MCT in healthy adults.
- 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
- Hyperreactive Airway Disease
- Being tested
- Methacholine Challenge Test
- Keywords
- IOS, oscillometry, spirometry, bronchial hyperreactivity
- Medical subject headings
- Bronchial Hyperreactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine Challenge TestDiagnostic test
Also called FEV1 measurement
MCT with IOS alone versus MCT IOS and FEV1 combined
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | No lung disease or symptoms. Negative methacholine Challenge Test. Receives: Diagnostic Test: Methacholine Challenge Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oscillometry; R5
Resistance at 5 Hz; kPa/L/s with FEV1 measurement
Measured: baseline (carried out with FEV1 measurement)
Oscillometry; R5
Resistance at 5 Hz; kPa/L/s change from baseline
Measured: 1-10 days from baseline and carried out without FEV1 measurement
Oscillometry; R20
Resistance at 20 Hz; kPa/l/s with FEV1 measurement
Measured: baseline (carried out without FEV1 measurement)
Oscillometry; R20
Resistance at 20 Hz; kPa/L/s change from baseline
Measured: 1-10 days from baseline and carried out without FEV1 measurement
Oscillometry; X5
Reactance at 5 Hz; kPa/l/s with FEV1 measurement
Measured: baseline (carried out without FEV1 measurement)
Oscillometry; X5
Reactance at 5 Hz; kPa/L/s change from baseline
Measured: 1-10 days from baseline and carried out without FEV1 measurement
Oscillometry; AX
Area of reactance; kPa/L with FEV1 measurement
Measured: baseline (carried out without FEV1 measurement)
Oscillometry; AX
Area of reactance; kPa/L change from baseline
Measured: 1-10 days from baseline and carried out without FEV1 measurement
Oscillometry; Fres
Resonant frequency; Hz with FEV1 measurement
Measured: baseline (carried out without FEV1 measurement)
Oscillometry; Fres
Resonant frequency; Hz change from baseline
Measured: 1-10 days from baseline and carried out without FEV1 measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start10 Aug 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion23 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hyperreactive Airway DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allergi- og Lungeklinikken, Elsinore
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Thomas Ringbæk, Allergi- og Lungeklinikken, Elsinore
- Investigators
- Thomas J Ringbæk, Principal investigator, Allergy and Lung Clinic Elsinore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509659
- Sponsor's protocol ID
- Elsinore_Healthy
- Status last verified
- Sep 2024
- First submitted
- 7 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28461290Cottini 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.
PubMed 35677830
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methacholine Challenge Test (MCT) in Healthy Adults: Oscillometry Measured Alone Compared to Oscillometry and FEV1 During the Same Test
- ClinicalTrials.gov ID
- NCT06509659
- Acronym / sponsor ID
- Elsinore_Healthy
- Conditions
- Hyperreactive Airway Disease
- Keywords
- IOS, oscillometry, spirometry, bronchial hyperreactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Allergi- og Lungeklinikken, ElsinoreResearch network
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 23 Dec 2024 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the IOS response to MCT in healthy adults.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Diagnostic Test: Methacholine Challenge TestNo lung disease or symptoms. Negative methacholine Challenge Test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (6 listed)
- Any lung disease
- Lung symptoms
- Medicine for lung disease
- Tobacco smoking
- Ex-smokers with more than 5 package years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methacholine Challenge TestAlso: FEV1 measurementMCT with IOS alone versus MCT IOS and FEV1 combined | Diagnostic test | Healthy controls |
Primary outcome
Oscillometry; R5
Time frame: baseline (carried out with FEV1 measurement)
Resistance at 5 Hz; kPa/L/s with FEV1 measurement
Oscillometry; R5
Time frame: 1-10 days from baseline and carried out without FEV1 measurement
Resistance at 5 Hz; kPa/L/s change from baseline
Oscillometry; R20
Time frame: baseline (carried out without FEV1 measurement)
Resistance at 20 Hz; kPa/l/s with FEV1 measurement
Oscillometry; R20
Time frame: 1-10 days from baseline and carried out without FEV1 measurement
Resistance at 20 Hz; kPa/L/s change from baseline
Oscillometry; X5
Time frame: baseline (carried out without FEV1 measurement)
Reactance at 5 Hz; kPa/l/s with FEV1 measurement
Oscillometry; X5
Time frame: 1-10 days from baseline and carried out without FEV1 measurement
Reactance at 5 Hz; kPa/L/s change from baseline
Oscillometry; AX
Time frame: baseline (carried out without FEV1 measurement)
Area of reactance; kPa/L with FEV1 measurement
Oscillometry; AX
Time frame: 1-10 days from baseline and carried out without FEV1 measurement
Area of reactance; kPa/L change from baseline
Oscillometry; Fres
Time frame: baseline (carried out without FEV1 measurement)
Resonant frequency; Hz with FEV1 measurement
Oscillometry; Fres
Time frame: 1-10 days from baseline and carried out without FEV1 measurement
Resonant frequency; Hz change from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 28461290Coates 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.
- Results publication: PubMed 35677830Cottini 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Frolund, MSci contact
Thomas J Ringbæk principal investigator
Allergy and Lung Clinic Elsinore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperreactive Airway Disease, run by Allergi- og Lungeklinikken, Elsinore at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Ringbæk, MSci (21969087, thomasringbaek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oscillometry; R5 (time frame: baseline (carried out with FEV1 measurement)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06509659, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.