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Active, not recruiting

NCT Number: NCT07792213

First-Line Diagnostic Investigations for Suspected Adult Asthma

Asthma is a common long-term condition that can be difficult to diagnose accurately. Symptoms such as breathlessness, wheeze and cough can vary over time and may be caused by other conditions. Some people with asthma have normal breathing test results when they are assessed, which can make diagnosis challenging and lead to delays in treatment.

This study aims to determine which commonly used tests, either alone or in combination, are most accurate for diagnosing asthma in adults with suspected disease. Participants referred to George Eliot Hospital for investigation of possible asthma will be invited to take part.

Following informed consent, participants will undergo a range of routine diagnostic tests during their first visit. These include spirometry with bronchodilator response testing in patient with both normal airway function and airflow obstruction, fractional exhaled nitric oxide (FeNO), which measures airway inflammation, and oscillometry, which assesses how air moves through the lungs. Participants will then attend a second visit for a bronchial provocation challange test, which helps determine whether the airways are unusually sensitive, a key feature of asthma.

The study will compare the results of these tests with the final diagnosis to assess how accurately each test identifies or excludes asthma. It will also investigate whether combining different tests improves diagnostic accuracy and whether factors such as obesity affect diagnostic measurements of increased asthma prevalence.

The findings will help improve understanding of the most effective ways to diagnose asthma in routine clinical practice. This may lead to faster and more accurate diagnoses, reduce the need for unnecessary investigations, and support better care for people with suspected asthma.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Asthma (Diagnosis) Asthma Bronchial Diseases Disease Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Physiological Sciences

Nuneaton, North Warwickshire, CV10 7DJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • •Adults aged 16years and older
  • Referral for objective investigation of suspected asthma
  • Ability to provide written informed consent

Exclusion criteria

  • Previous confirmed diagnosis of asthma or other chronic airways disease
  • Respiratory tract infection within six weeks prior to testing
  • Current smoker or ex-smoker with a greater than 10p\\pack-year smoking history
  • Inability to perform pulmonary function testing to acceptable technical standards
  • Contraindications to any of the diagnostic investigations as per departmental guidelines
  • Lack of capacity to provide informed consent

Treatment and study plan

Spirometry

Diagnostic Test

Participants will undergo standardised pre-bronchodilator spirometry using a calibrated spirometer operated by trained study personnel. Measurements will include forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), slow vital capacity (SVC), peak expiratory flow (PEF) and the FEV₁/FVC ratio. Participants will perform at least three acceptable forced expiratory manoeuvres, with the highest reproducible values recorded. Spirometry will be conducted at the protocol-specified study visit(s) to assess pulmonary function as an outcome measure. Testing will follow current international quality control and acceptability standards.

Fractional Exhaled Nitric Oxide

Diagnostic Test

Participants will undergo FeNO measurement using a calibrated nitric oxide analyser operated by trained study personnel. The test will be performed according to standardised international guidelines using a controlled exhalation at a constant flow rate. FeNO values, expressed in parts per billion (ppb), will be recorded to assess airway inflammation. Measurements will be obtained at protocol-specified study visit(s) under standardised testing conditions, with quality control procedures followed throughout testing.

bronchodilator response

Diagnostic Test

Participants will undergo bronchodilator response testing to assess for airway responsiveness in both obstructive and normal patients. Spirometry will be performed before and after administration of a standardised dose of an inhaled short-acting bronchodilator delivered via a metered-dose inhaler with a spacer. Post-bronchodilator spirometry will be conducted after the protocol-specified waiting period. Changes in forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), and other spirometric parameters will be recorded according to standardised international guidelines. Testing will be performed by trained study personnel using calibrated equipment.

oscillometry

Diagnostic Test

Participants will undergo respiratory oscillometry using a calibrated oscillometry device operated by trained study personnel. Measurements will be obtained during quiet tidal breathing according to standardised international guidelines. Respiratory impedance parameters, including airway resistance (e.g., R5, R20), reactance (e.g., X5), resonant frequency (Fres), and area of reactance (AX), will be recorded. At least three acceptable measurements meeting quality control criteria will be obtained. Testing will be performed at protocol-specified study visit(s) under standardised conditions to assess respiratory mechanics.

Bronchial Provocation challange test

Diagnostic Test

Participants will undergo a standardised bronchial provocation challenge to assess airway hyperresponsiveness. Increasing doses of a bronchial provoking agent will be administered according to a standardised protocol under the supervision of trained study personnel. Spirometry will be performed after each dose to measure changes in forced expiratory volume in one second (FEV₁). The test will continue until a predefined decline in FEV₁ is achieved or the maximum protocol dose is reached. Testing will be performed using calibrated equipment with continuous monitoring and appropriate safety procedures, following current international guidelines.

Primary outcomes

  1. Primary outcome measure- Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, and Area Under the ROC Curve of Combined First-Line Objective Testing for Asthma Diagnosis

    Time frame: 6 weeks

    Diagnostic performance of combined first-line objective investigations (fractional exhaled nitric oxide [FeNO], oscillometry, spirometry, and bronchodilator reversibility testing) compared with the composite reference standard incorporating bronchial provocation testing. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC).

Secondary outcomes

  1. Secondary out come measure - Number and Proportion of Participants Requiring Bronchial Provocation Testing Following First-Line Assessment

    Time frame: 6 weeks

    Number and proportion of participants who require bronchial provocation testing to confirm or exclude a diagnosis of asthma following completion of the first-line objective investigations.

  2. Diagnostic Concordance Between First-Line Objective Investigations and the Composite Reference Standard

    Time frame: 6 weeks

    Diagnostic concordance between FeNO, oscillometry, spirometry, and bronchodilator reversibility testing and the composite reference standard incorporating bronchial provocation testing for the diagnosis of asthma.

  3. Diagnostic Performance of First-Line Objective Investigations According to Obesity Status

    Time frame: 6 weeks

    Diagnostic performance of FeNO, oscillometry, spirometry, and bronchodilator reversibility testing compared with the composite reference standard, stratified according to obesity status using BMI, using the following categories:

    <18.5 18.5-24.9 25-29.9 30-34.9 35-39.9 >40

  4. Diagnostic Performance of First-Line Objective Investigations in Participants With Preserved Baseline Spirometry

    Time frame: 6 weeks

    Diagnostic performance of FeNO, oscillometry, and bronchodilator reversibility testing compared with the composite reference standard among participants with preserved baseline spirometry.

Sponsors and collaborators

Lead sponsor

George Eliot Hospital

Other

Registry information

Official study title

Comparative Diagnostic Accuracy of First-line Objective Tests for Asthma in Adults With Suspected Disease: Evaluation of Individual and Combined Tests, and the Impact of Normal Spirometry and Obesity.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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