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Also known as Ciprofloxacin DPI (BAYQ3939)
Ciprofloxacin DPI · 1 trial · 1 indication
Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
| Arm | Type | Description |
|---|---|---|
| Ciprofloxacin DPI 28 Days on/off (Cipro 28) | EXPERIMENTAL | Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles). |
| Ciprofloxacin DPI 14 Days on/off (Cipro 14) | EXPERIMENTAL | Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles). |
| Placebo 28 Days on/off (Placebo 28) | PLACEBO_COMPARATOR | Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles). |
| Placebo 14 Days on/off (Placebo 14) | PLACEBO_COMPARATOR | Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles). |
| Name | Type | Description |
|---|---|---|
| Ciprofloxacin DPI (BAYQ3939) | DRUG | Participants received 32.5 mg ciprofloxacin hydrated (corresponding to 50 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device. |
| Placebo | DRUG | Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device. |
Inclusion Criteria: * Patients with a proven and documented diagnosis of non Cystic Fibrosis (CF) idiopathic or post infectious bronchiectasis * Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks Exclusion Criteria: * Forced expiratory volume in 1 secon...
Top 3 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 3 | PHASE2 | AZD0292 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE2 | GSK3862995B |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Ensifentrine |
Ciprofloxacin DPI is an inhaled antibiotic being developed for bronchiectasis, a chronic respiratory condition in which the airways become damaged and widened. It is designed to deliver ciprofloxacin directly to the lungs in non-cystic fibrosis bronchiectasis. It is an investigational therapy and has not been approved for commercial use.
Ciprofloxacin DPI is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer holds the asset, also known as BAYQ3939, and has advanced it through clinical testing in respiratory medicine.
Ciprofloxacin DPI is in Phase 3 development. Its single Phase 3 trial, NCT01764841, has been completed. The program is not currently listed with any active trials. As an investigational product, it has not received regulatory approval for marketing.
Ciprofloxacin DPI has been studied in one Phase 3 trial, NCT01764841, titled Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis. The trial enrolled 416 adults, was randomized, double-blind, and placebo-controlled, and was conducted across the United States, Europe, Japan, Australia, New Zealand, Israel, and Argentina. It is now completed.
Yes, Ciprofloxacin DPI is also known as BAYQ3939. BAYQ3939 is the internal development code used by Bayer AG for this inhaled dry powder formulation of ciprofloxacin. Both names refer to the same investigational asset.