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

NCT07059767 | Recruiting Phase 2 DMC

• 2 other identifiers: ETH47-201ISRCTN21576805
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Change in peak of total lower respiratory symptoms score (LRSS)

  7 Questions on lower respiratory symptoms are scored from 0-3 (absent, mild moderate, severe)

  Day 1 to Day 14

Study Arms (2)

ETH47

EXPERIMENTAL

Drug: ETH47

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ETH47 DRUG

single intranasal dose of ETH47

ETH47

Placebo DRUG

single intranasal dose of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants aged ≥18 and ≤65 years at the time of obtaining informed consent.
• Diagnosis of clinical asthma (\>12% reversibility following short acting beta 2 agonist (SABA) treatment or PC20 methacholine challenge of \<8 mg/mL).
• 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.
• Clinically stable with no exacerbations within 3 months prior to dosing.
• Sero-negative test result to RV-A16.
• Participants must agree to use contraception methods (if applicable).

You may not qualify if:

• Any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.
• Evidence of current allergic rhinitis, including perennial allergic rhinitis, or rhinosinusitis or nasal polyps.
• History of or current diagnosis of chronic obstructive pulmonary disease, emphysema, cystic fibrosis or bronchiectasis.
• 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.
• 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.

Sponsors & Collaborators

• Ethris GmbH: lead
• VirTus Respiratory Research Ltd: collaborator

Study Sites (1)

Virtus Respiratory Research Ltd and Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma; Disease

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr. Philipp Schreppel

CONTACT

+4989244153042; schreppel@ethris.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 11, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)