Ciprofloxacin Dry Powder for Inhalation (also known as Ciprofloxacin DPI and BAYQ3939), from Bayer HealthCare and Novartis is an experimental therapy under development to reduce exacerbations, or flares, in people with non-CF bronchiectasis bacterial respiratory infections.
Ciprofloxacin is a fluoroquinolone antibiotic widely prescribed for acute lung infections. It has a broad-spectrum antibacterial activity, namely Pseudomonas aeruginosa, a strain of bacteria found frequently in lung infections of bronchiectasis patients.
Ciprofloxacin DPI is a formulation that includes ciprofloxacin dry powder for inhalation using the PulmoSphere technology and administered with the T-326 dry powder inhaler.
Ciprofloxacin DPI studies
A Phase 3 study (NCT01764841), RESPIRE 1, evaluated if treatment with Ciprofloxacin DPI could be used as a long-term intermittent therapy in patients with non-CF bronchiectasis. It compared patients who were intermittently administered ciprofloxacin DPI 32.5 mg twice daily for 28 days, then 28 days off treatment, or 14 days of treatment, then 14 days off treatment, versus placebo during a 48-week period. The primary objective of the study was to observe the time to first exacerbation or flare. Secondary objectives were the mean number of flares per participant, changes in lung function, as measured with Forced Expiratory Volume (FEV1), changes in the quality of life, as measured by the St. Georges Respiratory Questionnaire (SGRQ), the presence of new pathogens at the end of the treatment and the number of participants with adverse events.
Overall 416 participants were included. Ciprofloxacin DPI 14 day on/off treatment was well-tolerated and significantly prolonged time to first flare and significantly reduced frequency of exacerbation compared to placebo. The 28 day on/off treatment did not have a significant effect for either objective.
Another Phase 3 study (NCT02106832), RESPIRE 2, was completed in October 2016. The design of this study was similar to RESPIRE 1. It enrolled 519 participants 18 years and older who had non-CF bronchiectasis and a stable lung function, and who had been treated and in the four weeks before enrolling. Results for this study have not yet been presented.
Although results may be favorable regarding safety and effectiveness, Ciprofloxacin DPI has not yet been approved for treating flares in people with non-CF bronchiectasis.
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