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Also known as Ciprofloxacin (BAYQ3939) dry powder for inhalation
Ciprofloxacin dry · 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.
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 | Subjects 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 | Subjects 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 | Subjects 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 | Subjects 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 (BAYQ3939) dry powder for inhalation | DRUG | Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment. |
| Placebo | DRUG | Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off |
Inclusion Criteria: * Patients with a proven and documented diagnosis of non 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 second (FEV1) \<30% or ...
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 dry powder for inhalation is an investigational inhaled antibiotic developed for non-cystic fibrosis bronchiectasis, a chronic respiratory condition in which the airways become damaged and widened. It is delivered directly to the lungs as a dry powder rather than taken orally or intravenously.
Bayer AG is developing ciprofloxacin dry powder for inhalation. Bayer trades on the OTC market in the United States under the ticker BAYRY. The asset is also identified in development records as BAYQ3939.
Ciprofloxacin dry powder for inhalation has reached Phase 3 clinical development for non-cystic fibrosis bronchiectasis. It is an investigational therapy and has not been approved by the FDA for this indication.
The Phase 3 trial NCT02106832 evaluated ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. It enrolled 521 adults aged 18 and older, was randomized, double-blind, and placebo-controlled, and has been completed. Sites spanned the United States, Europe, Asia, Latin America, Australia, and South Africa.
Ciprofloxacin dry powder for inhalation contains ciprofloxacin, the same small-molecule antibiotic used in oral and intravenous formulations, but it is a distinct inhaled product. It is also known as ciprofloxacin (BAYQ3939) dry powder for inhalation, and the dry powder route delivers the drug directly to the airways.