Tests inhaled fexlamose in adults with moderate to severe COPD
Tests an inhaled drug against placebo in adults with moderate to severe COPD.
Plain-language title generated from the registry record
Registry title: A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD
Key facts
- Where
- Ferrol, Mataro, Mérida, and Zaragoza, SpainSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT06731959, who can take part
Where in Spain
- Area Sanitaria De FerrolFerrol, SpainNo longer taking part
- Clinica Respira-Dr.JuanolaMataro, SpainNo longer taking part
- Hospital de MéridaMérida, SpainNo longer taking part
- Hospital Universitario Miguel ServetZaragoza, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aer Therapeutics
- Trial code
- NCT06731959EU 2025-523020-50-00
- Record updated
- 13 December 2024
- Original description
AER-01-002 is a Phase 2a study being conducted to determine if inhaled fexlamose is an effective and safe treatment for adults with moderate to severe COPD.Read full original descriptionShow less
A Phase 2a, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fexlamose (AER-01) Inhalation Solution in the Treatment of Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease
AER-01-002 is a Phase 2a study being conducted to determine if inhaled fexlamose is an effective and safe treatment for adults with moderate to severe COPD.
Study will compare active drug to placebo.
Main Inclusion Criteria; Each participant must meet all the following criteria to be enrolled in this study:; Participant is male or female ≥40 to ≤80 years of age; Participant has a verified diagnosis of cigarette smoking-related COPD FEV1 that is >25% and <60% of predicted normal at Visit 1; Participant meets the following spirometry performance criteria:; Acceptability: Participant can perform acceptable spirometry (ie, meet ATS/ERS acceptability criteria) at Visits 1 and 2; Repeatability: Participant can perform technically acceptable spirometry meeting repeatability criteria for FEV1 during at least 1 of the prebronchodilator assessments at Visits 1 and 2; Participant is on stable maintenance COPD medications with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period; Participant has had ≤2 COPD exacerbations requiring hospitalization in the past year; Main Exclusion Criteria; Participants meeting any of the following criteria will be excluded from the study:; Participant has an active uncontrolled medical condition; Participant has a diagnosis of current asthma; Participant has primary diagnosis of bronchiectasis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or CF; Participant has had a COPD exacerbation in the 6 weeks prior to Visit 1; Participant has active lung infection; Participant has received any vaccine within 7 days prior to Day 1; Participant is taking a protein therapeutic for control of COPD or asthma: eg, dupilumab, tezepelumab, benralizumab, mepolizumab, omalizumab.