Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ciprofloxacin single dose, Ciprofloxacin (BAYO9867)
Ciprofloxacin · 10 trials · 10 indications
Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.
Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.
Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of \> 2 mL. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm
FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.
Firstly, scintigraphic imaging, a non-invasive method using a radioactive (99mTc-) label tagged to the formulation, will be used to describe the distribution and deposition of a single inhaled dose of Ciprofloxacin Dry Powder Inhalation (DPI) in the lung quantitatively. Secondly, based on blood sampling over a period of 24 hours after inhalation non-compartmental pharmacokinetic parameters of ciprofloxacin will be calculated to determine the systemic exposure to drug following inhalation of a single 32.5 mg Ciprofloxacin dose.
| Arm | Type | Description |
|---|---|---|
| Ciprofloxacin | EXPERIMENTAL | - |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Non-quinolone antibiotic | ACTIVE_COMPARATOR | Subjects receiving non-quinolone antibiotic (group followed-up for 2 years) |
| Ciprofloxacin Inhale (BAYQ3939) | EXPERIMENTAL | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily |
| Placebo | PLACEBO_COMPARATOR | Inhalation of matching placebo twice a day |
| 32.50 mg Ciprofloxacin DPI (BAYQ3939) | EXPERIMENTAL | 32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days |
| 48.75 mg Ciprofloxacin DPI (BAYQ3939) | EXPERIMENTAL | 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days |
| Matching Placebo for 32.50 mg | PLACEBO_COMPARATOR | Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days |
| Matching Placebo for 48.75 mg | PLACEBO_COMPARATOR | Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
| Arm 3 | EXPERIMENTAL | - |
| Arm 4 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ciprofloxacin (Cipro, BAYQ3939) | DRUG | (1) Community-acquired pneumonia (CAP): 400 mg BID, i.e. every 12 ± 1 hours (For those with Ccr \> 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days. 2\) Hospital-acquired pneumonia (HAP): For the patient with Ccr \> 60 mL/min, 400 mg TID, i.e. every 8 ± 1hours for 7 to 14 days For the patient with 30 ≤Ccr ≤60 mL/min, 400 mg BID, i.e. every 12 ± 1hours for 7 to 14 days 3) Secondary infection of chronic respiratory disease 400 mg BID, i.e. every 12 ± 1 hours (For those with of Ccr \> 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days. |
| Ciprofloxacin single dose | DRUG | Patients randomized to this regimen will receive a single-dose of ciprofloxacin MR 1000 mg PO approximately 2 to 3 hours prior to the TRNBP. Patients will also receive two doses of matching placebo approximately 24 hours prior to and approximately 24 hours after the TRNBP. |
| Ciprofloxacin triple dose | DRUG | Patients randomized to this regimen will receive three doses of ciprofloxacin MR 1000 mg PO. The doses will be approximately 24 hours prior to the TRNBP, approximately 2 to 3 hours prior to the TRNBP, and approximately 24 hours after the TRNBP. |
| Ciprofloxacin (BAYO9867) | DRUG | 400 mg iv BID |
| Ciprofloxacin | DRUG | Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label |
| Non-quinolone antibiotic | DRUG | Common used dose and route |
| Placebo | DRUG | Inhalation of matching placebo twice a day |
| Ciprofloxacin (Cipro Inhale, BAYQ3939) | DRUG | 32.5 mg ciprofloxacin DPI corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days |
| Ciprofloxacin (Cipro InhaIe, BAYQ3939) | DRUG | Ciprofloxacin Inhale 50 and 75 mg 2 times a day (BID) for 10 days |
Inclusion Criteria: * Males and non-pregnant, non-lactating females with written informed consent, 20 years of age or older. * Within 48 hours prior to the first study drug administration, all patients should have the pathogens identified with appropriate specimens (e.g., sputum, tracheal aspirate,...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
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Ciprofloxacin is an antibiotic being developed for bacterial infections, including bacterial pneumonia, bronchiectasis, burns, and pulmonary infections in conditions such as cystic fibrosis and chronic obstructive pulmonary disease. It is also being studied in inhaled formulations for patients with chronic lung diseases.
Ciprofloxacin is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is advancing the drug in multiple clinical programs, including a Phase 3 trial in bacterial pneumonia and Phase 1 studies of inhaled formulations.
Ciprofloxacin is in Phase 3 clinical development. A Phase 3 trial (NCT01561794) evaluated its safety, efficacy, and pharmacokinetics in patients with bacterial pneumonia. The drug is investigational and has not been approved for the indications currently under study.
Ciprofloxacin has been studied in several completed trials, including NCT01561794, a Phase 3 study in bacterial pneumonia; NCT01538667, a Phase 1 lung deposition study in healthy subjects and patients with chronic lung diseases; NCT01072942, a Phase 1 study in Japanese patients with moderate to severe COPD; and NCT01052298, a Phase 1 study in patients with mild to moderate COPD.
Yes, Ciprofloxacin is also known by several alternative names, including Cipro Inhale, BAYQ3939, and BAYO9867. These names refer to the same drug candidate or its inhaled formulations. Ciprofloxacin is the generic name, while Cipro is a well-known brand name for the oral form.