Last reviewed · How we verify
NCT06731959: AER-01-002
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
Phase 2 trial testing Flexlamose in COPD in 100 participants. Not yet recruiting.
1 November 2025
Quick facts
| Lead sponsor | Aer Therapeutics |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 December 2024 |
| Primary completion | 1 November 2025 |
| Estimated completion | 1 January 2026 |
Drugs / interventions tested
- Flexlamose — full drug profile →
- Placebo
Conditions studied
- COPD — all drugs for COPD →
Sponsor
Aer Therapeutics — full company profile →
Who can join
Adults 40 to 80, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
FEV1
Time frame: 4 weeks
Change from baseline in prebronchodilator FEV1 at Week 4
Sponsor's own 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. Study will compare active drug to placebo.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mucus as a Treatable Trait in Chronic Airway Diseases.
Cazzola M, Rogliani P, Ora J, Calzetta L, et al · · 2026 · cited 1× · PMID 41712061 · DOI 10.1007/s40265-026-02294-1 -
Molecular Approaches to Treating Chronic Obstructive Pulmonary Disease: Current Perspectives and Future Directions.
Vu SP, Veit K, Sadikot RT. · · 2025 · cited 1× · PMID 40076807 · DOI 10.3390/ijms26052184
Verify or expand the search:
- PubMed search for NCT06731959
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for COPD
Currently open trials in the same condition.
- NCT07344649 — Turkish Validation of the Nijmegen Questionnaire in COPD · recruiting
- NCT07524023 — Emotional-distress-based Integrated Care Programme in Patients With Stable COPD · NA · recruiting
- NCT07460154 — Structured Review: To Optimise Management and Prevent Harm in COPD · NA · recruiting
- NCT07462221 — Effect of Telenursing on Oral Health · NA · recruiting
- NCT07051707 — Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06731959 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aer Therapeutics
- Last refreshed: 9 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06731959.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing