Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT05006573) enrolled 99 people with a lung condition called non-cystic fibrosis bronchiectasis — 54 received the study drug benralizumab (30 mg) and 45 received a placebo (a dummy treatment). The trial was split into two phases: a double-blind period (where neither participants nor doctors knew who received which treatment) and an open-label extension period (where everyone knew). The main thing the trial was measuring was how often participants had flare-ups (called exacerbations) of their bronchiectasis over the course of the double-blind period. It also measured secondary things such as time until a first flare-up, lung function, and quality-of-life scores using a few different questionnaires. The reported data shows that during the double-blind period, people in the benralizumab group had a reported rate of 1.44 flare-ups per year, compared with 1.27 flare-ups per year in the placebo group. For time to first flare-up, the benralizumab group reached their first flare-up at a median of 233 days, compared with 316 days in the placebo group. On a respiratory symptoms quality-of-life questionnaire (scored 0–100, where higher means better), the benralizumab group showed score changes from baseline generally ranging from around 5 to 7 points across time points, while the placebo group showed changes ranging from approximately −1.5 to 3.1 points. Lung function (measured as the volume of air a person can forcefully breathe out in one second) showed small changes in both groups across multiple time points, with the reported figures provided at several intervals throughout the trial period. Cough-related quality-of-life scores and physical functioning scores were also reported at multiple time points for both groups, with the numbers available in the full data record. The reported data shows changes across several questionnaires and time points, and a complete breakdown of each time point is available in the full ClinicalTrials.gov record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Cystic Fibrosis Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 18 years of age or older
- A doctor has diagnosed you with non-cystic fibrosis bronchiectasis (a lung condition), and this has been confirmed by a CT scan
- You have had 2 or more bronchiectasis flare-ups (worsening of symptoms requiring treatment) within the past year
- If you are taking antibiotics regularly to prevent flare-ups, your dose has been stable for at least 3 months before joining, and you can keep it stable during the study (if you recently stopped a type of antibiotic called a macrolide, you must have been off it for at least 3 months before starting the trial)
- You are already using airway clearance or physiotherapy to help clear mucus from your lungs, and this routine has been stable for at least 3 months
- If you use inhaled steroids or inhalers to open your airways, your dose has been unchanged for at least 3 months before joining and can stay the same during the study
- If you are a woman who could become pregnant, you have had a negative pregnancy test before starting and agree to use a highly effective form of contraception during the study and for 12 weeks after your last dose
Who may not be able to join:
- You have another lung disease in addition to bronchiectasis (note: people with a history of a certain type of lung infection called NTM may still be eligible if they finished treatment at least 3 months ago and had a negative test result — confirm with trial site)
- You have been diagnosed with, or are suspected of having, another lung or whole-body condition that causes high levels of a certain type of white blood cell (eosinophils) in your blood
- You have had a chest infection or a bronchiectasis flare-up during the screening period before the trial starts
- You have any other health condition that your doctor feels is not stable and could put you at risk, affect the study results, or prevent you from completing the trial
- Your CT scan shows signs of another lung disease, signs of an active infection, or an unmonitored spot on the lung larger than 6mm that has not been tracked for at least 2 years
- You currently have an active liver disease
- You currently have cancer, or have had cancer in the past — with exceptions: certain skin cancers or cervical pre-cancers may be acceptable if fully treated and in remission for at least 1 year; other cancers may be acceptable if fully treated and in remission for at least 5 years (confirm with trial site)
- You have a known immune system disorder or have tested positive for HIV
- You have had issues with alcohol or drug misuse in the past year
- You are a current smoker or ex-smoker with a smoking history of 10 pack-years or more (a pack-year means smoking one pack of cigarettes a day for one year)
- You currently need long-term oxygen therapy at home
- You are currently taking part in, or are about to start, an intensive pulmonary rehabilitation programme (note: if you are in a maintenance phase of rehabilitation, you may still be eligible — confirm with trial site)
- You use a breathing support machine (non-invasive ventilation) for a reason other than sleep apnoea
- You have taken immune-suppressing medications in the last 3 months, or are likely to need them long-term during the study
- You have received a biologic medicine (a treatment made from living cells, such as a monoclonal antibody) within the past year
- You have taken part in another drug trial within the past 30 days (or within 5 half-lives of that drug — confirm with trial site)
- You have received immunoglobulin or blood products within the past 30 days
- You have received a live vaccine within 30 days before starting the trial
- You are currently enrolled in another clinical drug trial
- You have had a severe allergic reaction (anaphylaxis) to any biologic medicine or vaccine
- You have a known allergy to any ingredient in the trial medication
- You are involved in planning or running this study
- Your doctor believes for any reason that taking part would not be right for you
- You have already been enrolled in this same trial before
- You are currently pregnant or breastfeeding
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: James D. Chalmers, MD, University of Dundee, Nethergate, Dundee DD1 4HN, Scotland, UK
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.