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Cipro Inhale

Phase 1

Infection | Small molecule | Infectious Disease |Bayer AG|Last Updated: Apr 14, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Cipro Inhale · 1 trial · 2 indications

Phase 1 1
NCT01168895Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation PowderInfection
COMPLETED12 Analytics
PHASE1COMPLETED
Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder
InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Determination of ciprofloxacin pharmacokinetics derived from drug concentrations in blood, urine and sputum
Within 24 hours after treatment

Secondary Endpoints

Adverse events collection
Within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
Cipro Inhale (Ciprofloxacin, BAYQ3939)DRUG32.5 mg ciprofloxacin corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation
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Eligibility Criteria

Age Range40 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adult subjects with COPD, 40 - 75 years of age * All subjects must have a diagnosis of COPD and must have airway obstruction with a post-bronchodilator Forced Expiratory Volume in 1 sec (FEV1) of \>/= 30% and \<= 80% of predicted and a post-bronchodilator FEV1 / Forced Vital C...

Countries:Germany
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Frequently asked questions about Cipro Inhale

What is Cipro Inhale used for?

Cipro Inhale is an investigational small molecule being developed for the treatment of infection. It is a ciprofloxacin inhalation powder intended for delivery directly to the lungs. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Cipro Inhale?

Cipro Inhale is being developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is an inhaled formulation of ciprofloxacin, a small molecule antibiotic, and is currently in Phase 1 clinical development for the treatment of infections.

What phase is Cipro Inhale in?

Cipro Inhale is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for the treatment of infection.

What clinical trials is Cipro Inhale in?

Cipro Inhale has one completed Phase 1 clinical trial, NCT01168895, which investigated the safety, tolerability, and pharmacokinetics of single-dose inhalations of 50 mg and 75 mg ciprofloxacin inhalation powder. The trial enrolled 12 participants, including healthy volunteers, and was conducted in Germany.

Is Cipro Inhale the same as ciprofloxacin?

Cipro Inhale is an inhaled formulation of ciprofloxacin, a small molecule antibiotic. It is designed to deliver ciprofloxacin directly to the lungs via inhalation powder. The drug is being developed by Bayer AG and is currently in Phase 1 clinical development for the treatment of infection.