Assessing airway twitchiness in patients with severe asthma on biologics as they reduce their inhaled corticosteriod dose

Tailoring Inhaled Corticosteroids in patients with Severe Asthma taking Biologics

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN37454686

Enrollment

Registered

2025-07-16

Start date

2025-11-17

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Severe asthma patient on either dupilumab or tezepelumab Respiratory

Interventions

Participants will already be established on asthma biologic medications (either dupilumab or tezepelumab). Will will be on maximal maintenance and reliever inhaled therapy (Fostair NEXTHaler 100/6 4

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Any patient over 18 years of age with severe asthma taking dupilumab or tezepelumab for severe asthma for at least 6 months 2. FEV1 =50% at baseline

Exclusion criteria

Exclusion criteria: 1. Any patients on maintenance oral steroids or required an oral steroid burst in the past 28 days 2. Any patient who was switched from another biologic in the past 3 months 3. Any other respiratory condition such as moderate to severe bronchiectasis or COPD 4. Currently pregnant

Design outcomes

Primary

Measure	Time frame
Mannitol airway hyperresponsiveness measured using change in mannitol PD10 from Visit 1 (post-run-in baseline) to Visit 2 (6 months)	—

Secondary

Measure	Time frame
1. Blood eosinophil count is measured using automated haematology analyser at post-run-in baseline and 6 months 2. Total serum IgE is measured using immunoassay (e.g. ImmunoCAP) at post-run-in baseline and 6 months 3. Fractional exhaled nitric oxide (FeNO) is measured using a FeNO analyser (e.g. NIOX VERO) at post-run-in baseline and 6 months 4. Forced expiratory volume in 1 second (FEV1), forced expiratory flow at 25–75% of FVC (FEF25–75), and forced vital capacity (FVC) are measured using spirometry at post-run-in baseline and 6 months 5. Airway resistance (R5–R20) and reactance area (AX) are measured using impulse oscillometry at post-run-in baseline and 6 months 6. Airway hyperresponsiveness is measured using mannitol challenge test with PD15 as the outcome at 6 months 7. Airway reactance area (AX) is measured using impulse oscillometry at post-run-in baseline and 6 months	—

Measure

Time frame

1. Blood eosinophil count is measured using automated haematology analyser at post-run-in baseline and 6 months 2. Total serum IgE is measured using immunoassay (e.g. ImmunoCAP) at post-run-in baseline and 6 months 3. Fractional exhaled nitric oxide (FeNO) is measured using a FeNO analyser (e.g. NIOX VERO) at post-run-in baseline and 6 months 4. Forced expiratory volume in 1 second (FEV1), forced expiratory flow at 25–75% of FVC (FEF25–75), and forced vital capacity (FVC) are measured using spirometry at post-run-in baseline and 6 months 5. Airway resistance (R5–R20) and reactance area (AX) are measured using impulse oscillometry at post-run-in baseline and 6 months 6. Airway hyperresponsiveness is measured using mannitol challenge test with PD15 as the outcome at 6 months 7. Airway reactance area (AX) is measured using impulse oscillometry at post-run-in baseline and 6 months

—

Countries

Scotland, United Kingdom

Contacts

Public ContactRobert Greig

rgreig001@dundee.ac.uk+44 1382383188

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026