Bronchial HyperreactivityNCT06034145
Methacholine Challenge Testing: Comparison of FEV1 and IOS Parameters in Adult Asthma Patients
An observational study of Bronchial Hyperreactivity, run by Allergi- og Lungeklinikken, Elsinore.
Trial summary
A classic methacholine challenge test is considered positive when forced expiratory volumen after one second (FEV1) decrease 20%. Impulse oscillometry (IOS) measures airway resistance and reactance, and seems more sensitive to changes in small airways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Hyperreactivity
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a cross-sectional analysis of a single-centered, observational study on adult (≥18 years old) patients referred with known asthma or asthma-like symptoms to a lung specialist clinic
Who may be able to join
- Doctor diagnosed asthma (based on symptoms and at least one positive asthma test within the last 5 years (AHR; reversibility to beta2-agonist, ICS, prednisolone; peak flow variation).
- Written informed consent.
Who cannot join
- patients aged less than 18 years old.
- patients with an exacerbation or lower airway infection within 1 months.
- Pulmonary function test: FEV1 (% pred.) < 60%
- Not able to perform spirometry or body plethysmography.
- Cognitive disorders and not able to answer ACQ.
- Treated with biologics.
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- Pregnancy or breastfeeding
- Short-acting beta-agonists 6 h, long-acting beta-agonists 2 days, short-acting anti-muscarinic agent 12 h, Long-acting anti-muscarinic agents 7 days, and Montelukast 3 days before methacholine challenge test (MCT).
- Comorbidity with significant influence on lung function and pulmonary symptoms eg. COPD, bronchiectasis, ischemic heart disease, heart failure, atrial fibrillation, uncontrolled hypertension (>160/100 mmHg), lung cancer, lung resection, BMI>40 kg/m2.
Trial locations and contacts
No sites are listed yet.
About this study
A classic methacholine challenge test is considered positive when forced expiratory volumen after one second (FEV1) decrease 20%. Impulse oscillometry (IOS) measures airway resistance and reactance, and seems more sensitive to changes in small airways. In adult asthma patients, we compare methacholine challenge test using both FEV1 and IOS.
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 (GINA).
In general, FEV1 is used to test for airway hyperresponsiveness (AHR), and a 20% decrease after methacholine challenge is considered a positive test (Coates 2017; ERJ).
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 (Cottini M, J Allergy Clin Immunol Pract 2019; Cottini M, 2022; Postma 2019 Lancet Respir Med).
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.
A recent study showed that patients with a negative methacholine test measured by FEV1 may report asthma-like symptoms and may have a positive test when measured by IOS (Urbankowski; 2021). The question is whether these patients are a subgroup of patients with SAD (based on IOS at baseline) or are characterized in another way.
Knowledge on the proportion of patients with AHR only measured by IOS (not by FEV1) and the characteristics of these patients are sparse.
Hypothesis \& Aims The aim of the present study was to determine the proportion of AHR to methacholine measured by FEV1 and IOS, respectively, in patients with diagnosed asthma and to compare patient characteristics and asthma medication in these four groups of patients: 1) negative by FEV1 and IOS; 2) negative by FEV1 but positive by IOS; 3) positive by FEV1 but negative by IOS; 4) positive by both tests.
- Conditions
- Bronchial Hyperreactivity
- Being tested
- No intervention
- Keywords
- asthma, oscillometry, spirometry, bronchial hyperreactivity
- Medical subject headings
- Bronchial Hyperreactivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Asthma according to Gina Guidelines Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACQ-6
Asthma Control Questionnaire (ACQ6) will be used in the 6 sub-score version omitting FEV1 % of predicted
Measured: At entry (Cross sectional)
Impulse Oscillometry
Resistance at 5Hz (R5), R5-R20, reactance at 5Hz (X5), frequency response (Fres), areal under reactance curve (AX)
Measured: At entry
Demographic data
General demographic data, including age, sex (male/female), body mass index (BMI) (kg/m2), and smoking history will be recorded.
Measured: At entry
Biomarker
Serum eosinophils and hemoglobin will be measured
Measured: At entry
FeNO
Measurement of Exhaled Nitric Oxide by NOBreath
Measured: At entry
Lung function and body box
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and the percentage of FEV1 in the estimated value will be measured at baseline and after methacholine test by Vyntus, Vyaire Medical. Body plethysmography with residual volumen (RV), total lung capacity (TLC), diffusion capacity of the lungs for carbon monoxide (DLCO), will be measured before methacholine test by Medical Electronic Construction (MEC).
Measured: At entry
Asthma medication
Inhaled corticosteroids (ICS), long-acting beta2agonists (LABA), long-acting muscarinic antagonists (LAMA), Leukotriene antagonist, theophylline, and prednisolone - type and dose
Measured: At entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial HyperreactivityStudies 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
- 500 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 Ringbæk, MSci, Principal investigator, Allergy and Lung Clinic Elsinore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034145
- Sponsor's protocol ID
- Lungeklinikken_Elsinore
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication in per-reviewed papers;
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methacholine Challenge Testing: Comparison of FEV1 and IOS Parameters in Adult Asthma Patients
- ClinicalTrials.gov ID
- NCT06034145
- Acronym / sponsor ID
- Lungeklinikken_Elsinore
- Conditions
- Bronchial Hyperreactivity
- Keywords
- asthma, oscillometry, spirometry, bronchial hyperreactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Allergi- og Lungeklinikken, ElsinoreResearch network
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 13 Sep 2023 (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.
A classic methacholine challenge test is considered positive when forced expiratory volumen after one second (FEV1) decrease 20%. Impulse oscillometry (IOS) measures airway resistance and reactance, and seems more sensitive to changes in small airways. In adult asthma patients, we compare methacholine challenge test using both FEV1 and IOS.
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 (GINA).
In general, FEV1 is used to test for airway hyperresponsiveness (AHR), and a 20% decrease after methacholine challenge is considered a positive test (Coates 2017; ERJ).
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 (Cottini M, J Allergy Clin Immunol Pract 2019; Cottini M, 2022; Postma 2019 Lancet Respir Med).
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.
A recent study showed that patients with a negative methacholine test measured by FEV1 may report asthma-like symptoms and may have a positive test when measured by IOS (Urbankowski; 2021). The question is whether these patients are a subgroup of patients with SAD (based on IOS at baseline) or are characterized in another way.
Knowledge on the proportion of patients with AHR only measured by IOS (not by FEV1) and the characteristics of these patients are sparse.
Hypothesis \& Aims The aim of the present study was to determine the proportion of AHR to methacholine measured by FEV1 and IOS, respectively, in patients with diagnosed asthma and to compare patient characteristics and asthma medication in these four groups of patients: 1) negative by FEV1 and IOS; 2) negative by FEV1 but positive by IOS; 3) positive by FEV1 but negative by IOS; 4) positive by both tests.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Other: No interventionAsthma according to Gina Guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a cross-sectional analysis of a single-centered, observational study on adult (≥18 years old) patients referred with known asthma or asthma-like symptoms to a lung specialist clinic
Key inclusion criteria (2 listed)
- Doctor diagnosed asthma (based on symptoms and at least one positive asthma test within the last 5 years (AHR; reversibility to beta2-agonist, ICS, prednisolone; peak flow variation).
- Written informed consent.
Key exclusion criteria (9 listed)
- patients aged less than 18 years old.
- patients with an exacerbation or lower airway infection within 1 months.
- Pulmonary function test: FEV1 (% pred.) < 60%
- Not able to perform spirometry or body plethysmography.
- Cognitive disorders and not able to answer ACQ.
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 |
|---|---|---|
| No interventionNo intervention | Other | Asthma |
Primary outcome
ACQ-6
Time frame: At entry (Cross sectional)
Asthma Control Questionnaire (ACQ6) will be used in the 6 sub-score version omitting FEV1 % of predicted
Impulse Oscillometry
Time frame: At entry
Resistance at 5Hz (R5), R5-R20, reactance at 5Hz (X5), frequency response (Fres), areal under reactance curve (AX)
Demographic data
Time frame: At entry
General demographic data, including age, sex (male/female), body mass index (BMI) (kg/m2), and smoking history will be recorded.
Biomarker
Time frame: At entry
Serum eosinophils and hemoglobin will be measured
FeNO
Time frame: At entry
Measurement of Exhaled Nitric Oxide by NOBreath
Lung function and body box
Time frame: At entry
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and the percentage of FEV1 in the estimated value will be measured at baseline and after methacholine test by Vyntus, Vyaire Medical. Body plethysmography with residual volumen (RV), total lung capacity (TLC), diffusion capacity of the lungs for carbon monoxide (DLCO), will be measured before methacholine test by Medical Electronic Construction (MEC).
Asthma medication
Time frame: At entry
Inhaled corticosteroids (ICS), long-acting beta2agonists (LABA), long-acting muscarinic antagonists (LAMA), Leukotriene antagonist, theophylline, and prednisolone - type and dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: Undecided. Publication in per-reviewed papers;
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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.
Thomas Ringbæk, MSci principal investigator
Allergy and Lung Clinic Elsinore
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Hyperreactivity, run by Allergi- og Lungeklinikken, Elsinore.
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 2 inclusion and 9 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 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 (004521969087, thomasringbaek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACQ-6 (time frame: At entry (Cross sectional)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2023.