Recruiting PHASE2 Asthma (Diagnosis)

New treatment option for Asthma (Diagnosis)

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

ClinicalTrials.gov ID: NCT07059767

What this study is testing

What is ETH47?

ETH47 is an investigational medicine, being studied as a potential treatment for asthma (diagnosis).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join if

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)...
  • 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...
  • Clinically stable with no exacerbations within 3 months prior to dosing.

You likely can't join 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...
  • 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...
See the full eligibility criteria
Who can 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).
What rules you out
  • 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...
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • London, United Kingdom
  • Manchester, United Kingdom

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include London, United Kingdom; Manchester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.