Assessing airway twitchiness in patients with severe asthma on biologics as they reduce their inhaled corticosteriod dose
| ISRCTN | ISRCTN37454686 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37454686 |
| IRAS number | 346249 |
| Secondary identifying numbers | 2-071-24 |
- Submission date
- 15/07/2025
- Registration date
- 16/07/2025
- Last edited
- 16/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Asthma is a common lung condition that makes breathing difficult, especially when the airways become sensitive or "twitchy" in response to things like dust or pollen. This twitchiness is linked to a type of inflammation in the lungs called type 2 inflammation. People with this kind of asthma often have higher levels of certain markers in their blood and breath.
Asthma is usually treated with inhalers that contain steroids, but these don’t always reach the smallest parts of the lungs. Newer treatments called biologics, which are given by injection, can reach these areas and may help reduce inflammation more effectively.
This study aims to find out whether two commonly used biologic medications, dupilumab and tezepelumab, can reduce airway twitchiness enough that patients can safely lower their dose of steroid inhalers without losing control of their asthma.
Who can participate?
The study is for adults with severe asthma who are already being treated with either dupilumab or tezepelumab.
What does the study involve?
Participants will use a standard steroid inhaler in a specific way called maintenance and reliever therapy. They will attend three study visits over six months, including a screening visit. They will provide blood samples to measure inflammation markers and take breathing tests to check lung function, including a special test to measure how twitchy the airways are.
What are the possible benefits and risks of participating?
Benefits may include better understanding and management of asthma, and possibly reducing the steroid dose safely. Risks include side effects from reducing steroid use, such as worsening asthma symptoms. There are also known side effects from long-term use of high-dose steroid inhalers, which this study hopes to help reduce. Blood tests and breathing tests may cause minor discomfort.
Where is the study run from?
The study is being run at the Scottish Centre of Respiratory Medicine, based at the University of Dundee’s Ninewells campus (UK)
When is the study starting and how long is it expected to run for?
May 2024 to August 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Professor Brian Lipworth, b.j.lipworth@dundee.ac.uk
Contact information
Principal Investigator
Scottish Centre for Respiratory Research Mailbox 2
Molecular & Clinical Medicine School of Medicine
University of Dundee Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
 ORCID ID |
0000-0002-8140-2014 |
|---|---|
| Phone | +44 1382383188 |
| b.j.lipworth@dundee.ac.uk |
Public, Scientific
Scottish Centre for Respiratory Research Mailbox 2
Molecular & Clinical Medicine School of Medicine
University of Dundee Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
| ORCID ID |
0000-0001-7668-286X |
|---|---|
| Phone | +44 1382383188 |
| rgreig001@dundee.ac.uk |
Study information
| Study design | Phase IV single arm open labelled |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home, Hospital |
| Study type | Quality of life, Treatment |
| Participant information sheet | 47674 Participant Information Sheet 30.06.25 V3 marked.pdf |
| Scientific title | Tailoring Inhaled Corticosteroids in patients with Severe Asthma taking Biologics |
| Study acronym | TICSAB |
| Study objectives | 1. To characterize the effect of tapering inhaled corticosteroids on mannitol airway hyperresponsiveness in patients with severe asthma taking dupilumab or Tezepelumab 2. Assess the effects of taking dupilumab or tezepelumab on small airways dysfunction using airways oscillometry. 3. To characterise symptom control and quality of life scores as participants adjust their inhaled corticosteroid dose. 4. To assess type 2 inflammation in as participants adjust their inhaled corticosteroid dose. |
| Ethics approval(s) |
Approved 08/07/2025, East of Scotland Research Ethics Service (EoSRES) (Tayside Medical Science Centre, Residency Block Level 3, George Pirie Way, Ninewells Hospital and Medical School, Dundee, DD1 9SY, United Kingdom; +44 1382660111; tay.eosres@nhs.scot), ref: 25/ES/0043 |
| Health condition(s) or problem(s) studied | Severe asthma patient on either dupilumab or tezepelumab |
| Intervention | 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 puffs BD) and reduce their MART dose as able during the study (between 2 and 8 puffs daily) over a 6 month period. They will undergo airway oscillometry, spirometry, mannitol challenge, blood tests, FeNO and questionnaires to assess symptom control and quality of life at 3 visits (including a screening visit). |
| Intervention type | Other |
| Primary outcome measure | Mannitol airway hyperresponsiveness measured using change in mannitol PD10 from Visit 1 (post-run-in baseline) to Visit 2 (6 months) |
| Secondary outcome measures | 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 |
| Overall study start date | 01/05/2024 |
| Completion date | 01/08/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 46 |
| Total final enrolment | 46 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2025 |
| Date of final enrolment | 10/01/2026 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Dundee
DD1 9SY
United Kingdom
Sponsor information
University/education
Tayside Medical Science Centre, Ninewells Hospital & Medical School
Research & Development Office Residency Block, Level 3, George Pirie Way
Dundee
DD1 9SY
Scotland
United Kingdom
| Phone | +44 1382383297 |
|---|---|
| tascgovernance@dundee.ac.uk | |
| Website | https://www.dundee.ac.uk/tasc |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/08/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available on request from Prof Brian Lipworth (b.j.lipworth@dundee.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 30/06/2025 | 16/07/2025 | No | Yes |
| Protocol file | version 2 | 30/06/2025 | 16/07/2025 | No | No |
Additional files
Editorial Notes
15/07/2025: Trial's existence confirmed by East of Scotland Research Ethics Service (EoSRES).
