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Molecular signatures associated with response to ICS treatment in patients with COPD stratified by eosinophil levels
EU CTIS ID: 2023-505245-13-00
What this study is testing
To determine the molecular changes associated with the use of ICS in COPD patients with different blood eosinophil counts.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female patients ≥40 years of age.
- ≥ 10 pack-years smoking.
- Former smokers (≥6 months).
- post-bronchodilator FEV1/FVC<0.70.
- FEV1 ≥30 (i.e. mild-moderated COPD patients).
- Signed written informed consent form.
You likely can't join if
- Presence of other respiratory disorders, (i.e. current physician diagnosis of asthma, early life history of asthma (<21 years) a previous clinical diagnosis of bronchiectasis, interstitial lung disease, pulmonary eosinophilia).
- Participating in another randomized trial.
- Not likely to complete the study.
- Pregnant or breastfeeding females.
- Exacerbations in the previous 8 weeks.
- Blood eosinophil count <100 eos/mcL
See the full eligibility criteria
- Male and female patients ≥40 years of age.
- ≥ 10 pack-years smoking.
- Former smokers (≥6 months).
- post-bronchodilator FEV1/FVC<0.70.
- FEV1 ≥30 (i.e. mild-moderated COPD patients).
- Signed written informed consent form.
- On regular treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage.
- Women of child-bearing potential must have a negative pregnancy test in serum or urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence.
- Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
- Presence of other respiratory disorders, (i.e. current physician diagnosis of asthma, early life history of asthma (<21 years) a previous clinical diagnosis of bronchiectasis, interstitial lung disease, pulmonary eosinophilia).
- Participating in another randomized trial.
- Not likely to complete the study.
- Pregnant or breastfeeding females.
- Exacerbations in the previous 8 weeks.
- Blood eosinophil count <100 eos/mcL
- Primary or secondary immunodeficiency.
- Immunosuppression or regular oral corticosteroid treatment.
- Allergy to IMP’s excipients.
- Any circumstances which could contradict study participation and lead the investigator to assess the patient as unsuitable for study participation for any other reason.
- Long-term oxygen therapy or non-invasive mechanical ventilation at home.
- Current smokers.
- Active cancer.
- Use of ICS in the 3 months prior to the recruitment.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.