Phase IIa Trial in Participants With Asthma to Evaluate Impact of Intranasal ETH47 on Development of Asthma-related Symptoms Following Rhinovirus Challenge

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-24

Study Completion Date

2026-06-30

Brief Summary

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A Phase IIa trial in participants with asthma to evaluate the impact of intranasal ETH47 on the development of asthma-related symptoms following rhinovirus challenge

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Detailed Description

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Conditions

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Asthma (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ETH47

Group Type EXPERIMENTAL

ETH47

Intervention Type DRUG

single intranasal dose of ETH47

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single intranasal dose of placebo

Interventions

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ETH47

single intranasal dose of ETH47

Intervention Type DRUG

Placebo

single intranasal dose of placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No