Can an inhaled drug ease bronchiectasis? a trial seeks answers
NCT ID NCT07731919
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial tests an inhaled investigational drug called ALX1 in adults with bronchiectasis, a chronic lung condition that causes coughing and mucus buildup. Participants receive either ALX1 or a placebo for 14 days. The study aims to find safe and effective doses for future research by monitoring side effects and changes in key biomarkers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an inhaled investigational drug called ALX1
- What this could lead to
- If it works, this could point toward a new inhaled treatment for bronchiectasis, a chronic lung condition.
- What could go wrong
- This is an early phase 2a trial with only 28 participants, so results may not apply to everyone. The drug is inhaled and could cause side effects like changes in blood oxygen or heart rhythm.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Current sputum producer with a history of chronic expectoration that, in the opinion of the Investigator, will be able to continue to reliably provide sputum throughout the study. * Confirmed diagnosis of BE per high-resolution computed tomography (HRCT) prior to Screening due to any of the following: NCFB, CF, primary ciliary dyskinesia, or COPD. * Clinical history consistent with BE (cough, daily chronic sputum production, and/or recurrent respiratory infections). * FEV1 ≥ 40% of predicted values at Screening. * Able to reproducibly perform spirometry manoeuvres (i.e., able to perform at least 3 acceptable forced expiratory curves based on the PI's assessment). * History of at least one exacerbation treated with a course of antibiotics (inhaled, oral or intravenous \[IV\]) within the 24 months prior to Screening * Woman of childbearing potential (WOCBP) or fertile man (see definitions in Section 5.3) agrees to use an acceptable method of contraception from the start of Screening until 90 days after the last dose of IP. Exclusion Criteria: * Negative sputum NEATstik result for neutrophil elastase at Pre-screening. * History of Burkholderia cepacia complex within 2 years prior to Pre-screening and/or detection of any Burkholderia spp. in sputum culture or by polymerase chain reaction (PCR) at Screening. * History of Aspergillus fumigatus requiring treatment within 12 months prior to Pre-screening. * History of non-tuberculosis mycobacteria (NTM) infection requiring treatment within 12 months prior to Screening, or detection of one or more NTM species in sputum by PCR at Screening. * History of bronchospasm with inhaled antibiotics or hypertonic saline. * Haemoptysis exceeding 50 mL of blood from the respiratory tract at any time within 30 days prior to IP administration (Day 1). * Initiated macrolide therapy within 90 days before Screening. Existing stable maintenance with inhaled macrolides is permitted if initiated more than 90 days prior to Screening. * Received inhaled anti-pseudomonal therapy within the last 14 days before Pre-screening. Must be willing to refrain from use of inhaled anti-pseudomonal therapy during the study until completion of the Follow-up video/telephone call. * Received oral antibiotics other than macrolide within 30 days prior to Screening. Must be willing to refrain from use of oral antibiotics during the study until completion of the Follow-up video/telephone call. * Received IV antibiotics within 60 days prior to Screening * Initiation of, or increase in the dose of, inhaled corticosteroids within 90 days prior to Screening. Note: participants may be taking stable inhaled corticosteroids at the time of enrolment but must have initiated treatment more than 90 days prior to Screening * Started any of the following muco-corrective therapies (e.g., nebulised saline, N-acetyl cysteine, Pulmozyme®, etc.) within 30 days prior to Screening. Maintenance with these muco-corrective therapies is permitted if initiated 30 days prior to Screening. * Any of the following laboratory abnormalities at Screening: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN) 2. Creatinine \> 1.5 × ULN * QT interval corrected by Fridericia's formula (QTcF) interval \> 450 ms for males or \> 470 ms for females at Screening, or history of prolonged QT syndrome. PR interval \< 200 ms at Screening. Out-of-range values may be repeated twice for confirmation. The mean QTcF and PR intervals of the triplicate ECG recordings will be used to determine qualification. * Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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