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 enrolled 164 people in total — 84 received a placebo (an inactive treatment given three times daily) and 80 received 75 mg of aztreonam lysine for inhalation (AZLI), also three times daily. The trial was measuring several things in people with cystic fibrosis who had a lung infection caused by a bacteria called *Pseudomonas aeruginosa*. These included changes in lung function, the amount of bacteria in sputum (mucus coughed up from the lungs), and how participants rated their own respiratory symptoms. Of those who started, 57 people in the placebo group and 67 in the AZLI group completed the trial; the data was not reported explaining all individual reasons for non-completion. The reported data shows the following numbers at the end of the study period. For lung function — measured as the percentage change in how much air a person can forcefully breathe out in one second (called FEV1) — the placebo group showed a change of approximately −2.4%, while the AZLI group showed a change of approximately +7.9%. For the amount of *Pseudomonas aeruginosa* bacteria measured in sputum, the placebo group showed a small increase (a log change of +0.07) while the AZLI group showed a decrease (a log change of −1.38 — meaning roughly a large reduction in the measured bacterial count). For self-reported respiratory symptoms, scored on a scale of 0 to 100 where higher means fewer symptoms, two separate time-point measurements were reported: one showed changes of approximately +1.0 (placebo) versus +7.0 (AZLI), and another showed changes of approximately −5.7 (placebo) versus +0.6 (AZLI). The trial also tracked other bacteria in sputum samples and measured how much of the drug was needed to inhibit the target bacteria, though those results were reported as group-wide figures rather than individual participant outcomes. 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 ↗ · Read the linked publication on PubMed (PMID 19420195) ↗
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, Completed
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 have a confirmed diagnosis of cystic fibrosis (CF), shown by a sweat test result, a genetic test finding two known CF gene changes, or an abnormal test of nasal airway function.
- A bacteria called Pseudomonas aeruginosa was found in your sputum (mucus you cough up) or a throat swab at the screening visit.
- Your lung function test (measuring how much air you can breathe out) falls between 25% and 75% of what is expected for someone your age and size.
- You have a negative pregnancy test at the screening visit.
- You are able to perform lung function (breathing) tests in a consistent and repeatable way.
- Your blood oxygen level is 90% or higher while breathing normal room air at the screening visit.
- You are able to read, understand, and sign a consent form agreeing to take part.
Who may not be able to join:
- You have taken antibiotics targeting Pseudomonas bacteria (by inhaler, IV drip, or by mouth, including azithromycin) in the 14 days before the screening visit.
- You are currently taking oral steroid tablets (such as prednisone) at doses higher than 10 mg per day or 20 mg every other day.
- A bacteria called Burkholderia cepacia has been found in your sputum or throat swab at any point in the past 2 years.
- You currently need oxygen continuously every day, or need more than 2 litres per minute of oxygen at night.
- You have taken part in another clinical trial or used an experimental drug or device within the past 28 days (or longer, depending on the drug involved).
- You have a known allergy or sensitivity to a group of antibiotics called monobactams (confirm with trial site).
- You are unable to use a short-acting inhaler (bronchodilator) at least three times a day.
- Any of your permitted medications (such as antibiotics, inhalers, anti-inflammatory drugs, or steroids) have been changed within 7 days before the screening visit or between screening and your next appointment.
- Your chest physiotherapy routine or schedule has changed within 7 days before the screening visit or between screening and your next appointment.
- You have previously had a lung transplant.
- Your most recent chest X-ray (taken at screening or within the past 90 days) shows unusual findings.
- Your kidney or liver function tests show abnormal results at the screening visit.
- You have a serious ongoing physical or mental health condition that, in the doctor's judgement, could interfere with your treatment or ability to follow the trial plan.
- You have used inhaled saltwater (hypertonic saline) therapy in the 14 days before your first trial visit (except when used specifically to collect a sputum sample).
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: Bruce Montgomery, MD, Corus Pharma, Inc.
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
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change in CFQ-R Respiratory Symptoms Scale (RSS) Score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.