Diagnostic Utility of Different Airway Resistance Assessment Techniques in the Methacholine Challenge Test

NCT02343419 | Completed

• 1 other identifier: PFT-DIMPA-WUM1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare standard spirometric evaluation of methacholine challenge test with plethysmographic, interrupter technique and forced oscillation technique (FOT) evaluation of the airways resistance. The study group will consist of patients referred for methacholine challenge test. All patient will undergo spirometric, plethysmographic, interrupter technique and FOT examinations - before and after inhalation of aerosols. Patients will also undergo the measurement of nitric oxide concentration in exhaled air and laboratory tests, including: blood count, measurement of serum C-reactive protein, sodium, potassium, creatinine, immunoglobulin E and N-Terminal pro-brain natriuretic peptide (NT-proBNP) concentration. The investigators intend to assess, if plethysmographic, and/or interrupter, and/or FOT measurement of bronchial reactivity can replace standard spirometric assessment. Plethysmography, interrupter technique and FOT are much more easier to perform for patients. Furthermore, those two techniques are less dependent on patient's motivation and cooperation ability. Thus, usage of FOT, interrupter technique and/or plethysmography in bronchial hyperreactivity testing could make methacholine challenge test more comfortable and available for more patients. The investigators are also going to analyze the relationship between exhaled nitric oxide and functional indices of bronchial hyperreactivity.

Conditions

Bronchial Hyperreactivity; Abnormal Respiratory Airway Resistance

Keywords

Bronchial Hyperreactivity; Bronchial Provocation Tests; Methacholine Chloride; Respiratory Function Tests; Spirometry; Airway Resistance; Plethysmography

Outcome Measures

Primary Outcomes (1)

• The concentration of methacholine inducing a 20% fall in FEV(1) from post-diluent baseline [PC(20)]

  In case of FEV1 decrease of \> 20% from baseline PC (20) will be calculated by logarithmic interpolation.

  up to 2 hours

Secondary Outcomes (13)

• Change in FOT resistance and reactance from post-diluent baseline after inhalating consecutive methacholine aerosols

  within 6 minutes after methacholine aerosol inhalation

• Change in plethysmographic airway resistance from post-diluent baseline after inhalating consecutive methacholine aerosols

  within 6 minutes after methacholine aerosol inhalation

• Change in interrupter airway resistance from post-diluent baseline after inhalating consecutive methacholine aerosols

  within 6 minutes after methacholine aerosol inhalation

• Change in FEV(1) from from post-diluent baseline after inhalating consecutive methacholine aerosols

  within 6 minutes after methacholine aerosol inhalation

• Assessment of the difficulty level of FOT

  after methacholine challenge test (up to 2 hours two hours from the start of the methacholine challenge test)

Other Outcomes (2)

• Measurement of nitric oxide concentration in exhaled air

  Participanst will undergo measurement of nitric oxide concentration in exhaled air immediately before bronchial challenge test, total time of measurement: approximately 10 minutes

• Laboratory tests

  Patients will undergo laboratory tests once before perfoming methacholine challenge test; maximum period between the methacholine challenge test and performing laboratory tests: one month

Study Arms (1)

Bronchial challenge test

EXPERIMENTAL

Patients will undergo Methacholine Challenge Test assessed by forced oscillation technique (FOT), plethysmography, interrupter technique and spirometry.

Other: Methacholine Challenge Test

Interventions

Methacholine Challenge Test OTHER

Forced oscillation technique test, plethysmography, interrupter technique test and spirometry will be performed in a row before any intervention and after inhalation of aerosols - normal saline, followed by increasing concentrations of methacholine: 0.03 mg/ml; 0.06 mg/ml; 0.125 mg/ml; 0.25 mg/ml, 0.5 mg/ml, 1 mg/ml, 2 mg/ml, 4 mg/ml, 8 mg/ml, 16 mg/ml. In case of FEV1 decrease of ≥ 20% of the initial value methacholine challenge test will be ceased and patient will be administered 200 µg of salbutamol in inhalation. Then, pulmonary function tests will be performed after 15 minutes.

Bronchial challenge test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of asthma symptoms without confirmation of diagnosis by standard methods
• dyspnea and/or cough of unknown etiology

You may not qualify if:

• FEV1 \<1.2 L or \<60% of predicted value
• acute heart failure
• myocardial infarction in last 3 months
• transient ischaemic attack or stroke in last 3 months
• aneurysms
• methacholine allergy
• pregnant and lactating women
• administration of β2-mimetic, anticholinergic agent or theophylline before methacholine challenge test in 6, 8 and 24 hours, respectively
• respiratory tract infection in last 6 weeks
• patient inability to cooperate

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Internal Medicine, Pneumonology and Allergy, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

Location

Related Publications (1)

• Urbankowski T, Przybylowski T. Methacholine Challenge Testing: Comparison of FEV1 and Airway Resistance Parameters. Respir Care. 2021 Mar;66(3):449-459. doi: 10.4187/respcare.08331. Epub 2020 Nov 17.

  PMID: 33203723 DERIVED

MeSH Terms

Conditions

Bronchial Hyperreactivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Tomasz A Urbankowski, MD

  Department of Internal Medicine, Pneumonology and Allergy, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: January 22, 2015
• Study Start: November 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 9, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)