Intranasal ETH47 to prevent asthma symptoms after a cold virus exposure

A Phase IIa, Double-blind, Randomized, Placebo-controlled Trial in Participants With Asthma to Evaluate the Impact of Intranasal ETH47 on the Development of Asthma-related Symptoms Following Rhinovirus Challenge

This trial will test whether a nasal spray called ETH47 can prevent asthma symptoms in adults with asthma after deliberate exposure to a common cold virus.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ethris GmbH (industry)
• Locations: 1 site (London)
• Trial ID: NCT07059767 on ClinicalTrials.gov

What this trial studies

This Phase IIa, randomized, placebo-controlled interventional trial gives adults with diagnosed, stable asthma either intranasal ETH47 or placebo and then exposes them to rhinovirus A16 to see if asthma-related symptoms develop. Participants must be 18–65, on stable inhaled corticosteroid therapy (with or without LABA), seronegative to RV-A16, and free of recent colds or exacerbations. The trial uses a controlled rhinovirus challenge model with close clinical monitoring to compare symptom development and respiratory responses between the ETH47 and placebo groups. Safety, tolerability, and symptom outcomes after viral challenge will be collected to inform further development.

Who should consider this trial

Good fit: Adults aged 18–65 with diagnosed, clinically stable asthma on inhaled corticosteroids (±LABA), seronegative to RV-A16, and without recent colds or exacerbations are the ideal candidates.

Not a fit: People with recent or current upper respiratory symptoms, active allergic rhinitis, seropositivity to RV-A16, uncontrolled or severe asthma, children, or those unable to attend in-person clinic visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, ETH47 could reduce or prevent rhinovirus-triggered asthma symptoms and lower the risk of exacerbations related to common colds.

How similar studies have performed: Rhinovirus challenge models are well-established for testing interventions but intranasal ETH47 represents a relatively novel therapeutic approach with limited prior human data reported.

Eligibility criteria

Inclusion Criteria:

1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
2. Participants aged ≥18 and ≤65 years at the time of obtaining informed consent.
3. Diagnosis of clinical asthma (\>12% reversibility following short acting beta 2 agonist (SABA) treatment or PC20 methacholine challenge of \<8 mg/mL).
4. Stable (no change in medication or dose) asthma maintenance therapy with inhaled glucocorticosteroids (ICS) or ICS + long acting beta 2 agonist (LABA) for at least 3 months prior to dosing.
5. Clinically stable with no exacerbations within 3 months prior to dosing.
6. Sero-negative test result to RV-A16.
7. Participants must agree to use contraception methods (if applicable).

Exclusion Criteria:

1. Any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.
2. Evidence of current allergic rhinitis, including perennial allergic rhinitis, or rhinosinusitis or nasal polyps.
3. History of or current diagnosis of chronic obstructive pulmonary disease, emphysema, cystic fibrosis or bronchiectasis.
4. The evidence of any other historic, active or chronic disease following a detailed medical and surgical history which, in the Investigator's judgement, puts the participant at risk due to participation in the trial, may influence the results of the trial, or the participant's ability to participate in the trial. This includes a history of emergency room visits or hospital admissions due to common cold.
5. Current vaper or smoker, or ex-smoker who stopped within the last 12 months or with a \>5 year pack history; current vapers may be included if willing to stop prior to Baseline.

Where this trial is running

London

• Virtus Respiratory Research Ltd and Imperial College Healthcare NHS Trust — London, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Dr. Philipp Schreppel

Conditions: Asthma