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Cipro Inhale

Phase 1

Infection | Small molecule | Infectious Disease |Bayer AG|Trials 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

Cipro Inhale clinical trials

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?

Cipro Inhale is an investigational inhaled formulation of ciprofloxacin, a small molecule antibiotic developed by Bayer AG. It is being studied for infection, including use in patients with chronic obstructive pulmonary disease. It is delivered as an inhalation powder rather than by oral or intravenous administration.

What is Cipro Inhale used for?

Cipro Inhale is being developed for the treatment of infection, with clinical study conducted in subjects with chronic obstructive pulmonary disease. It is an investigational product and has not been established as a marketed treatment. Its intended use is delivery of ciprofloxacin directly to the lungs via inhalation powder.

Who makes Cipro Inhale?

Cipro Inhale is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical program for this inhaled ciprofloxacin formulation.

What phase is Cipro Inhale in?

Cipro Inhale is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program remains investigational and has not been approved by the FDA.

What clinical trials is Cipro Inhale in?

Cipro Inhale has been studied in one completed Phase 1 trial, NCT01168895. That randomized, double-blind, controlled study enrolled 12 participants in Germany, including healthy volunteers aged 40 years and older, and evaluated safety, tolerability, and pharmacokinetics of single inhaled doses of 50 mg and 75 mg ciprofloxacin inhalation powder in subjects with chronic obstructive pulmonary disease.

Is Cipro Inhale the same as ciprofloxacin or BAYQ3939?

Yes. Cipro Inhale is also known as ciprofloxacin and by the development code BAYQ3939. Ciprofloxacin is the active small molecule antibiotic, and Cipro Inhale refers to the inhaled powder formulation of that compound being developed by Bayer AG.