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 288 people in total across four groups. Participants received either one of two doses of an inhaled antibiotic powder called Ciprofloxacin DPI (32.50 mg or 48.75 mg), or a matching inactive powder (placebo) for each dose. The trial was measuring lung function and bacterial levels in sputum (mucus coughed up from the lungs) in people with a lung condition involving a bacteria called *Pseudomonas aeruginosa*. Around 74–93 people in each active treatment group and 21–47 in each placebo group finished the study. The reported data shows that the main thing being measured was a lung function test called FEV1 — essentially how much air a person can forcefully breathe out in one second, expressed as a percentage of what would normally be expected for someone of that age and size. At the main measurement point (around days 28–30), the 32.50 mg group showed a change of −1.0%, the 48.75 mg group −0.62%, and both placebo groups showed −2.2%, compared to where each group started. The reported data also shows changes in the amount of *Pseudomonas aeruginosa* bacteria detected in sputum samples over time, with both active dose groups showing larger reductions in bacterial levels compared to the placebo groups at several time points. For the outcome measuring the time to a first lung flare-up requiring treatment, the data was not reported for any of the four groups. Other lung function measures (FVC and FEF 25–75%) were also tracked at multiple time points, with various small changes recorded across all groups; the specific numbers varied by visit and group as reported in the submitted data. 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 26688732) ↗
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 2 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 (or your legal guardian) must be willing and able to sign a consent form agreeing to take part in the study
- You must be between 12 and 17 years old, or 18 years old or older
- You must have a confirmed diagnosis of Cystic Fibrosis (CF), shown by specific test results and genetic testing
- Your lungs must have a long-term infection with a bacteria called Pseudomonas aeruginosa, confirmed by a mucus or throat swab test within the past 12 months and again at the screening visit
- You must be able to do breathing tests that give consistent, repeatable results
- You must be able to cough up mucus naturally, without any help
- Your lung function (measured by a breathing test called FEV1) must be between 35% and 75% of what is expected for someone your size and age
- Your blood oxygen level must be 88% or higher when breathing normal room air
- You must have been off most antibiotics (except a type called macrolides) and off oral Ciprofloxacin for at least 30 days before starting the study drug
- Your CF treatment routine (including physiotherapy, exercise, and any macrolide antibiotics) must have been stable for at least 30 days before starting the study and must stay the same throughout the study
- You must be able to understand instructions and commit to taking part for the full length of the study
- Women who could become pregnant must be willing to use a reliable form of contraception for 3 months after receiving the study drug (examples include the pill, coil/IUD, diaphragm with gel, surgical sterilisation, or their partner using a condom or having had a vasectomy)
Who may not be able to join:
- You have a health condition unrelated to CF that could affect the study results (for example, previous chest surgery)
- Your Pseudomonas aeruginosa infection has been found to be highly resistant to the antibiotic Ciprofloxacin (confirm with trial site)
- You have had a respiratory tract infection with a bacteria called Burkholderia cepacia complex in the past 12 months
- You have a known fungal infection called aspergillosis that is causing symptoms, or a severe form of it called ABPA with very high allergy marker levels
- Your liver enzyme levels are more than 3 times the upper end of the normal range
- You have had a major coughing-up-of-blood episode (a large amount or requiring a blood transfusion) in the past 4 weeks
- You have received antibiotic treatment given through a drip (intravenously) for a lung flare-up in the past 30 days
- You have another medical condition that, in the opinion of the study doctor, would prevent you from safely completing the study
- You have had a fever or feverish illness within 1 week before the study starts
- You are currently being treated for a type of bacterial infection called non-tuberculosis mycobacteria
- You have taken part in another clinical trial involving an experimental drug within the past 30 days
- You have ever had an allergic reaction to a group of antibiotics called fluoroquinolones or quinolones (this includes Ciprofloxacin)
- You have been taking oral steroid tablets at a dose greater than 20 mg per day for more than 14 days during the past 3 months
- Your kidney function test results are more than twice the upper end of the normal range (confirm with trial site)
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: Bayer Study Director, Bayer
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 From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.