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 compared two forms of the antibiotic tobramycin in people with cystic fibrosis who had a lung infection caused by a bacterium called *Pseudomonas aeruginosa*. One group received tobramycin as an inhaled powder (TIP) and the other received it as an inhaled liquid solution (TOBI). A total of 308 people were assigned to the powder group and 209 to the liquid group, with 225 and 171 respectively completing the study. The trial measured a range of things including unwanted medical events that occurred during treatment, the amount of drug that entered the bloodstream, lung function, bacteria levels in sputum (mucus coughed up from the lungs), hearing, and how satisfied patients were with their treatment. The reported data shows that when it came to unwanted medical events during the study, 278 out of 308 people in the powder group and 176 out of 209 in the liquid group experienced at least one such event. Serious events (those involving hospitalisation, life-threatening situations, or similar) were recorded for 85 people in the powder group and 61 in the liquid group. For lung function — measured as the amount of air a person can forcibly breathe out in one second, expressed as a percentage of what is typical — both groups started at around 52–53% at the beginning of the study. By the end of the third treatment cycle, the reported change from the starting point was a small decrease of 0.4% in the powder group and 1.6% in the liquid group. Bacteria levels in sputum were reduced from baseline in both groups across the treatment cycles. Regarding how much of the drug entered the bloodstream, the levels measured were low in both groups, ranging from undetectable before dosing up to around 1.4 µg/mL (micrograms per millilitre) at peak in the powder group and 1.2 µg/mL in the liquid group. On the patient satisfaction survey (scored 0–100, with higher meaning more satisfied), one area — relating to convenience — showed a notably higher reported score for the powder group (75.4) compared with the liquid group (20.19). The reported data also shows that a decrease in hearing was recorded in a small proportion of participants in both groups, with the exact percentages varying depending on the frequency of sound tested. 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, 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.
- You are male or female and at least 6 years old at the time of screening.
- Your lung function test (measuring how much air you can breathe out in one second) falls within a specific moderate range — not too low and not too high — based on your age, sex, and height (confirm with trial site).
- A specific type of bacteria called Pseudomonas aeruginosa was found in your mucus or throat swab within the last 6 months, and is also found at your screening visit.
- You are able to follow all of the study's requirements.
- Your doctor considers your condition to be currently stable.
- If you are a woman who could become pregnant, you are using an effective form of contraception.
- You are able to give written consent to take part, and agree to the study's privacy terms before any study procedures begin.
Who may not be able to join:
- A bacteria called Burkholderia cepacia has been found in your mucus or throat swab within the last 2 years, or is found at your screening visit.
- You have coughed up more than about 4 tablespoons of blood from your lungs or airways in the 30 days before starting the study drug.
- You have a known allergy or sensitivity to a group of antibiotics called aminoglycosides, or to inhaled antibiotics.
- You are pregnant, breastfeeding, or planning to become pregnant during the study.
- You have a history of significant hearing loss or chronic ringing in the ears, as judged by the study doctor.
- You have used certain antibiotics (aimed at Pseudomonas) by mouth, injection, or inhalation in the 28 days before starting the study drug.
- You have used a type of water tablet (loop diuretics) in the 7 days before starting the study drug.
- You have taken part in another clinical trial or used an experimental treatment in the 28 days before starting the study drug.
- You recently started (within the last 28 days) certain long-term medications, including a type of antibiotic called macrolides, dornase alpha, or inhaled steroids — though you may still be eligible if you started these more than 28 days before the study drug begins.
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: Michael Konstan, MD, University Hospitals Cleveland Medical Center
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
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Treatment-emergent Adverse Events
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.