Asthma (Diagnosis)Phase 2ETH47-201NCT07059767
Phase IIa Trial in Participants With Asthma to Evaluate Impact of Intranasal ETH47 on Development of Asthma-related Symptoms Following Rhinovirus Challenge
A Phase 2 study testing ETH47 in people with Asthma (Diagnosis), run by Ethris GmbH at 2 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- ETH47
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 24 Jun 2025to 1 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Imperial College Healthcare NHS Trust
London
Medicines Evaluation Unit Limited
Manchester
About this study
Official title: 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
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)
- Being tested
- ETH47, Placebo
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETH47Drug
single intranasal dose of ETH47
PlaceboDrug
single intranasal dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| ETH47 | Experimental | Not described Receives: Drug: ETH47 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start24 Jun 2025
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethris GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VirTus Respiratory Research Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059767
- Sponsor's protocol ID
- ETH47-201
- Other IDs
- ISRCTN21576805
- Acronym
- ETH47-201
- Status last verified
- Nov 2026
- First submitted
- 27 Jun 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07059767
- Acronym / sponsor ID
- ETH47-201 / ETH47-201
- Conditions
- Asthma (Diagnosis)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ethris GmbHIndustry (pharma, biotech, devices)
- Collaborators
- VirTus Respiratory Research Ltd
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETH47 | Experimental | Drug: ETH47 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETH47single intranasal dose of ETH47 | Drug | ETH47 |
| Placebosingle intranasal dose of placebo | Drug | Placebo |
Primary outcome
Change in peak of total lower respiratory symptoms score (LRSS)
Time frame: Day 1 to Day 14
7 Questions on lower respiratory symptoms are scored from 0-3 (absent, mild moderate, severe)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ETH47 in people with Asthma (Diagnosis), run by Ethris GmbH at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak of total lower respiratory symptoms score (LRSS) (time frame: Day 1 to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.