AsthmaPhase 4NCT03141424
Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma
A Phase 4 study testing Tapering of inhaled corticosteroid (ICS) treatment in people with Asthma, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Background: Asthma is a common chronic condition characterized by respiratory symptoms and hyperresponsive airways. According to treatment guidelines, patients with persistent asthma require daily treatment with inhaled corticosteroids (ICS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Tapering of inhaled corticosteroid (ICS) treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2022to 25 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Astma patients followed in the Respiratory Outpatient Ward, Hvidovre Hospital, Amager Hospital or Glostrup Hospital.
- At least one of the following test suggestive for asthma, performed at any time during the outpatient course: 1) FEV1-reversibility on at least 12% and 200 ml after administration of bronchodilator or Prednisolon course, 2) positive bronchial provocation test, such as mannitol, 3) peakflow (PF)-variation of at least 20% assessed during a 14-day period, measured twice daily and at asthmatic symptoms, or 4) Variability in FEV1 on at least 12% and 200 ml
- Age 18-65 years
- Treated with ICS daily in doses equivalent to Budesonide 800 microg daily or more
- ICS adherence of at least 80% during the last year, assessed from used prescriptions
- Serum-periostin < 50 ng/ml at screening (8)
Show all 9Show fewer
- FeNO < 25 ppb at all prior visits
- Blood-eosinophils <0,15 at screening
- Signed informed consent
Who cannot join
- History of allergic asthma
- Doctor-diagnosed pneumonia within 6 weeks prior to screening
- Daily smoking or former daily smoking within the last 6 months
- Known other respiratory conditions such as COPD or pulmonary sarcoidosis
- Known other chronic conditions that could impact or prevent study participation, including severe heart conditions and conditions requiring treatment with immunosuppressive drugs such as Prednisolon, Methotrexate or biological treatments, assessed by study doctor
- Pregnancy or planned pregnancy
- Abuse of alcohol or other recreational drugs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Respiratory Research Unit, Copenhagen University Hospital Hvidovre
Hvidovre, 2650
About this study
Background: Asthma is a common chronic condition characterized by respiratory symptoms and hyperresponsive airways. According to treatment guidelines, patients with persistent asthma require daily treatment with inhaled corticosteroids (ICS). However, certain subgroups of asthma patients such as non-eosinophilic asthma patients do not respond well to the ICS treatment. In the present study, asthma patients treated with ICS and exhibiting low levels of eosinophilic biomarkers such as S-periostin, FeNO and blood eosinophils, are randomized 1:1 to either 1) tapering of ICS or 2) usual care. Thus, the aim of the present study is to investigate whether patients with non-eosinophilic asthma can sustain their level of disease control during ICS tapering.
Design: This is a randomized, controlled, one-center, non-inferiority study of ICS tapering in patients with non-eosinophilic asthma.
Read more
Inclusion and exclusion criteria: 1) Objectively secured asthma diagnosis, 2) Age 18-65 years, 3) ICS treatment equivalent to Budesonide 800 microg daily or more with at least 80% adherence, 4) Serum-periostin < 50 ng/ml, 5) FeNO<25 ppb at all prior visits, 6) Blood-eosinophils<0.15 at screening, 7) no allergic asthma history, 8) no daily smoking within 6 months, 9) no other respiratory disease, 10) no daily treatment with immunosuppressives, 11) no pregnancy, and 12) no history of drug or alcohol abuse.
Endpoints: Primary: Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS and time from baseline to drop-out. Secondary: Change in FeNO, change in Serum-Periostin, change in FEV1, change in blood-eosinophils.
Methods: Relevant patients will be recruited from Respiratory Outpatient Wards. In total, 110 patients will be required. Visits will be performed at screening, at week 0, 4, 8, 12, 16, 26, 52. In the active arm, ICS dosage will be reduced to 50% at week 0 and removed at week 8. All visits include ACQ, FeNO, spirometry, blood eosinophils. S-periostin will be measured at screening and at week 8 and 16.
- Conditions
- Asthma
- Being tested
- Tapering of inhaled corticosteroid (ICS) treatment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapering of inhaled corticosteroid (ICS) treatmentDrug
Also called budesonide, fluticasone proprionate, mometasone furoate, beclometasone dipropionate
Tapering of ICS treatment over 8 weeks. Follow-up over 52 weeks in total. Dosis reduction of 50% in ICS treatment for 8 weeks, followed by total ICS removal. Other inhaled asthma medication remains unchanged during the entire study period.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Usual care. Unchanged asthma medication during the entire study period. |
| Group B | Experimental | Tapering of ICS over 8 weeks. Dosis reduction of 50% in ICS treatment for 8 weeks, followed by total ICS removal. Other inhaled asthma medication remains unchanged during the entire study period. Receives: Drug: Tapering of inhaled corticosteroid (ICS) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS
Measured: 52 weeks
Time from baseline to drop-out
Measured: 52 weeks
Secondary outcomes (4)
Change in FeNO
Measured: 52 weeks
Change in FEV1
Measured: 52 weeks
Change in blood eosinophils
Measured: 52 weeks
Change in serum periostin
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Jun 2022
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Mosbech, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141424
- Sponsor's protocol ID
- Asthmaperiostin
- Status last verified
- Mar 2025
- First submitted
- 3 May 2017
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mosbech CH, Godtfredsen NS, Ulrik CS, Westergaard CG. Biomarker-guided withdrawal of inhaled corticosteroids in asthma patients with a non-T2 inflammatory phenotype - a randomized controlled trial study protocol. BMC Pulm Med. 2023 Oct 4;23(1):372. doi: 10.1186/s12890-023-02679-y.
PubMed 37794472
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT03141424
- Acronym / sponsor ID
- Asthmaperiostin
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Asthma is a common chronic condition characterized by respiratory symptoms and hyperresponsive airways. According to treatment guidelines, patients with persistent asthma require daily treatment with inhaled corticosteroids (ICS). However, certain subgroups of asthma patients such as non-eosinophilic asthma patients do not respond well to the ICS treatment. In the present study, asthma patients treated with ICS and exhibiting low levels of eosinophilic biomarkers such as S-periostin, FeNO and blood eosinophils, are randomized 1:1 to either 1) tapering of ICS or 2) usual care. Thus, the aim of the present study is to investigate whether patients with non-eosinophilic asthma can sustain their level of disease control during ICS tapering.
Design: This is a randomized, controlled, one-center, non-inferiority study of ICS tapering in patients with non-eosinophilic asthma.
Inclusion and exclusion criteria: 1) Objectively secured asthma diagnosis, 2) Age 18-65 years, 3) ICS treatment equivalent to Budesonide 800 microg daily or more with at least 80% adherence, 4) Serum-periostin < 50 ng/ml, 5) FeNO<25 ppb at all prior visits, 6) Blood-eosinophils<0.15 at screening, 7) no allergic asthma history, 8) no daily smoking within 6 months, 9) no other respiratory disease, 10) no daily treatment with immunosuppressives, 11) no pregnancy, and 12) no history of drug or alcohol abuse.
Endpoints: Primary: Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS and time from baseline to drop-out. Secondary: Change in FeNO, change in Serum-Periostin, change in FEV1, change in blood-eosinophils.
Methods: Relevant patients will be recruited from Respiratory Outpatient Wards. In total, 110 patients will be required. Visits will be performed at screening, at week 0, 4, 8, 12, 16, 26, 52. In the active arm, ICS dosage will be reduced to 50% at week 0 and removed at week 8. All visits include ACQ, FeNO, spirometry, blood eosinophils. S-periostin will be measured at screening and at week 8 and 16.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Usual care. Unchanged asthma medication during the entire study period. |
| Group B | Experimental | Drug: Tapering of inhaled corticosteroid (ICS) treatmentTapering of ICS over 8 weeks. Dosis reduction of 50% in ICS treatment for 8 weeks, followed by total ICS removal. Other inhaled asthma medication remains unchanged during the entire study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Astma patients followed in the Respiratory Outpatient Ward, Hvidovre Hospital, Amager Hospital or Glostrup Hospital.
- At least one of the following test suggestive for asthma, performed at any time during the outpatient course: 1) FEV1-reversibility on at least 12% and 200 ml after administration of bronchodilator or Prednisolon course, 2) positive bronchial provocation test, such as mannitol, 3) peakflow (PF)-variation of at least 20% assessed during a 14-day period, measured twice daily and at asthmatic symptoms, or 4) Variability in FEV1 on at least 12% and 200 ml
- Age 18-65 years
- Treated with ICS daily in doses equivalent to Budesonide 800 microg daily or more
- ICS adherence of at least 80% during the last year, assessed from used prescriptions
Key exclusion criteria (7 listed)
- History of allergic asthma
- Doctor-diagnosed pneumonia within 6 weeks prior to screening
- Daily smoking or former daily smoking within the last 6 months
- Known other respiratory conditions such as COPD or pulmonary sarcoidosis
- Known other chronic conditions that could impact or prevent study participation, including severe heart conditions and conditions requiring treatment with immunosuppressive drugs such as Prednisolon, Methotrexate or biological treatments, assessed by study doctor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapering of inhaled corticosteroid (ICS) treatmentAlso: budesonide, fluticasone proprionate, mometasone furoate, beclometasone dipropionateTapering of ICS treatment over 8 weeks. Follow-up over 52 weeks in total. Dosis reduction of 50% in ICS treatment for 8 weeks, followed by total ICS removal. Other inhaled asthma medication remains unchanged during the entire study period. | Drug | Group B |
Primary outcome
Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS
Time frame: 52 weeks
Time from baseline to drop-out
Time frame: 52 weeks
4 secondary outcomes
Change in FeNO
Time frame: 52 weeks
Change in FEV1
Time frame: 52 weeks
Change in blood eosinophils
Time frame: 52 weeks
Change in serum periostin
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 37794472Mosbech CH, Godtfredsen NS, Ulrik CS, Westergaard CG. Biomarker-guided withdrawal of inhaled corticosteroids in asthma patients with a non-T2 inflammatory phenotype - a randomized controlled trial study protocol. BMC Pulm Med. 2023 Oct 4;23(1):372. doi: 10.1186/s12890-023-02679-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tapering of inhaled corticosteroid (ICS) treatment in people with Asthma, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.