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How stopping inhaled corticosteroid puffers for different periods before a breathing test affects the accuracy of asthma diagnosis in adults.

Withholding Inhaled Corticosteroids (ICS) for Key Evaluation in Bronchoprovocation Diagnostics (WICKED Trial): A Prospective Randomized Control Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000001392
Acronym
WICKED
Enrollment
120
Registered
2026-01-06
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to find out whether stopping inhaled corticosteroid (ICS) puffers for a longer period before a breathing test makes the test more accurate in diagnosing asthma. Many people use ICS puffers regularly to control asthma symptoms, but these medicines can temporarily reduce airway sensitivity and may cause false-negative results when testing for asthma. In this study, adults referred for a bronchoprovocation (breathing challenge) test will be randomly assigned to withhold their ICS medication for either 72 hours (standard practice) or seven days, with some extending to three weeks if needed. Researchers will then compare how often the test correctly detects asthma between the groups. The study’s main hypothesis is that longer ICS withholding periods will improve the sensitivity and accuracy of asthma testing. Findings from this research may help refine national testing guidelines and improve how asthma is diagnosed and managed in clinical practice.

Interventions

Participants allocated to the intervention arm (Group B) will be required to withhold their usual inhaled corticosteroid (ICS) therapy for seven days prior to bronchoprovocation testing. Following completion of the seven-day withholding period, participants will undergo a standard bronchoprovocation test. If the initial bronchoprovocation test result is negative, participants will continue to withhold ICS therapy for a total duration of three weeks, after which the bronchoprovocation test will

Participants allocated to the intervention arm (Group B) will be required to withhold their usual inhaled corticosteroid (ICS) therapy for seven days prior to bronchoprovocation testing. Following completion of the seven-day withholding period, participants will undergo a standard bronchoprovocation test. If the initial bronchoprovocation test result is negative, participants will continue to withhold ICS therapy for a total duration of three weeks, after which the bronchoprovocation test will be repeated. Participants will be provided with written instructions detailing the ICS withholding requirements, an asthma action plan, and contact details for clinical support throughout the withholding period. On each test day, participants will undergo fractional exhaled nitric oxide (FeNO) testing, baseline spirometry, a bronchoprovocation challenge, and post-challenge spirometry, and will complete the Asthma Control Questionnaire (ACQ-5). The intervention will be delivered face to face and on an individual basis by respiratory scientists, with oversight of participant safety provided by a respiratory nurse practitioner. Participants may also receive telephone contact during the withholding period for clarification or support, as required. Participants who experience significant worsening of symptoms or require systemic corticosteroids during the withholding period will be withdrawn from the intervention and managed in accordance with their asthma action plan and standard clinical care. Adherence to the intervention will be assessed at the testing visit by confirmation of the timing of the participant’s last ICS dose. Fidelity will be supported through standardised written instructions, predefined testing protocols, investigator blinding to group allocation, and routine data quality and safety monitoring. No study medications will be administered.

Sponsors

Mater Misericordiae LTD
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(1) Adults aged 18 years or older. (2) Individuals referred for bronchoprovocation testing with equivocal or normal spirometry but ongoing clinical suspicion of asthma. (3) Participants must be current users of inhaled corticosteroids (ICS) at the time of screening. (4) Participants must have a stable respiratory condition with no recent asthma exacerbation requiring systemic corticosteroids in the preceding two weeks. (5) All participants must have an active and up-to-date asthma action plan, including access to rescue reliever medication and systemic corticosteroids (prednisolone) for use if clinically indicated. (6) Participants must be able to provide informed consent and comply with all study procedures and follow-up requirements.

Exclusion criteria

(1) Recent respiratory illness: Presence of an active or recent respiratory tract infection that could influence airway responsiveness or test safety. (2) Unstable asthma: History of brittle or poorly controlled asthma or a recent exacerbation requiring systemic corticosteroids within the previous two weeks, where temporary ICS withdrawal would be unsafe. (3) Cardiovascular contraindications: Known angina pectoris, recent myocardial infarction (within six months), or uncontrolled hypertension, all of which pose a risk during bronchoprovocation testing. (4) Recent surgery: History of recent thoracic, abdominal, or ocular surgery, as bronchoprovocation may cause strain or pressure changes that risk surgical complications. (5) Pregnancy: Current pregnancy or risk of pregnancy, as methacholine challenge testing is contraindicated due to potential fetal risk. (6) Substance intake affecting airway tone: Consumption of caffeine-containing substances (coffee, tea, cola, chocolate, or energy drinks) on the day of testing, which may alter airway responsiveness and confound results. (7) Inability to comply: Individuals who are unable to follow study instructions, withhold medication as directed, or attend testing appointments.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026