Identifying molecular responses to ICS treatment in COPD patients based on eosinophil levels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to recruit clinically stable former smokers with Chronic Obstructive Pulmonary Disease (COPD) who have been on dual long-acting bronchodilator treatment for at least 8 weeks. Participants will be randomized to receive Budesonide, and the study will focus on identifying molecular signatures related to the response to inhaled corticosteroid (ICS) treatment, specifically stratified by eosinophil levels and the influence of the pulmonary microbiome. The study will involve multiple international centers to gather diverse data on patient responses.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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).
* 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.
* Participating in another randomized trial.
* Not likely to complete the study.
* Pregnant or breastfeeding females.
* Exacerbations in the previous 8 weeks.
* 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.

Where it's running

• Philips University of Marburg
  Marburg, Germany Recruiting
• Academisch Ziekenhuis Groningen
  Groningen, Netherlands Recruiting
• Clínic Barcelona
  Barcelona, Spain Recruiting
• Son Espases
  Palma de Mallorca, Spain Recruiting
• University of Leicester
  Leicester, United Kingdom Not yet recruiting
• Imperial College London
  London, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: Rosa Faner
• Email: rfaner@recerca.clinic.cat
• Phone: +34932775400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.