SIGNATURE - The use of gene profiling to predict treatment response in severe asthma and in obstructive lung disease with elements of both astma and COPD

SIGNATURE - the 6-gene signature as a predictor of response to treatment in severe asthma and ACOS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000495-28-DK

Enrollment

125

Registered

2017-03-30

Start date

2017-05-18

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Severe asthma and astma-COPD overlap syndrome MedDRA version: 20.0 Level: LLT Classification code 10077006 Term: Asthma-COPD overlap syndrome System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10003561 Term: Asthma, unspecified System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855

Interventions

Trade Name: Prednisolon DAK Product Name: Prednisolon Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolon CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - =18 years old. - Signed informed consent. Subjects must fulfill one of the following; - Severe asthma as classified by =1 of following: ? * Maintenance therapy with ICS equivalent to =1600µg of budesonide daily AND a second controller (LABA, LTRA, or xanthines). ? * OCS for 50% or more days in the previous year . OR - ACOS (as classified as =1 of BOTH the asthma and COPD features listed.) ? COPD-features: • FEV1/FVC ratio =65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: - Current daily OCS treatment. - Pregnancy. - Change in ICS maintenance therapy in the preceding 4 weeks. - Recent exacerbation defined as =1 in the preceding 4 weeks: * Antibiotics due to airway infection. * Hospitalization due to airway infection. * OCS due to worsening of disease control. - If the subject is unable to understand written information and thus fill out questionnaires due to languages barriers. - Permanently incapable patients - Confirmed concurrent airway disease. - Other serious systemic and/or autoimmune disease * ASA 3 or worse or by investigator determination - Subjects who, by investigator determination, will not be able to adhere to the study protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to develop a tool able to predict response to oral corticosteroids in patients with severe asthma or ACOS using the 6-gene signature as well as ;Secondary Objective: The secondary objective of the trial is to assess the impact of smoking in patients with severe eosinophilic asthma, with regards to cell composition in blood and sputum and the impact of smoking on treatment response and change in cell composition after treatment. ;Primary end point(s): Lung function: o Change in FEV1 after intervention ;Timepoint(s) of evaluation of this end point: Before intervention (day 1) and after intervention (day 15)	—

Measure

Time frame

Main Objective: The main objective of the trial is to develop a tool able to predict response to oral corticosteroids in patients with severe asthma or ACOS using the 6-gene signature as well as ;Secondary Objective: The secondary objective of the trial is to assess the impact of smoking in patients with severe eosinophilic asthma, with regards to cell composition in blood and sputum and the impact of smoking on treatment response and change in cell composition after treatment. ;Primary end point(s): Lung function: o Change in FEV1 after intervention ;Timepoint(s) of evaluation of this end point: Before intervention (day 1) and after intervention (day 15)

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Secondary

Measure	Time frame
Secondary end point(s): Change in: o Symptom score: ACQ, MRC o Quality of life: miniAQLQ o Airway reactivity to mannitol o Induced sputum (differential count and gene expression profile) o FeNO in exhalation o Blood test (differential count, IgE) o Concentration of specific immune cells (ILCs) and cytokines in sputum and blood ;Timepoint(s) of evaluation of this end point: Before intervention (day 1) and after intervention (day 15)	—

Measure

Time frame

Secondary end point(s): Change in: o Symptom score: ACQ, MRC o Quality of life: miniAQLQ o Airway reactivity to mannitol o Induced sputum (differential count and gene expression profile) o FeNO in exhalation o Blood test (differential count, IgE) o Concentration of specific immune cells (ILCs) and cytokines in sputum and blood ;Timepoint(s) of evaluation of this end point: Before intervention (day 1) and after intervention (day 15)

—

Countries

Denmark

Contacts

Public ContactCeleste Porsbjerg

Respiratory Research Unit, Bispebjerg University Hospital

celeste.porsbjerg@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026