Cipro Inhaler for Cystic Fibrosis Children Ages 6-12 | NCT00910351

Studies
Cipro Inhaler for Cystic Fibrosis Children Ages 6-12

NCT00910351

Sponsor

Bayer

Status

Completed

Last Update Posted

Nov 21, 2013Estimated

Enrollment

19Actual

Phase

Phase 1

Conditions

Pseudomonas Infection

Interventions

Ciprofloxacin (Cipro, BAYQ3939)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

May 28, 2009

First Submission Date that Met QC Criteria

May 28, 2009

First Posted Date

May 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2013

Last Update Posted Date

Nov 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Ciprofloxacin (Cipro, BAYQ3939)

Name	Type	Description	Arm Group Labels	Other Names
Ciprofloxacin (Cipro, BAYQ3939)	Drug	25 mg inhaled Ciprofloxacin	Arm 1

Measure	Description	Time Frame
To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF patients, aged 6 - 12 years		Two weeks post screening

Measure	Description	Time Frame
To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration		Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients with cystic fibrosis confirmed by genetic testing and / or by sweat test
Colonization with P. aeruginosa confirmed in sputum in the past 12 months
Cohort 1: greater than or equal to 18 years of age.
Cohort 2: 6 - 12 years of age (inclusive)
Normal Body Mass Index: BMI between 14.5 and 30 kg/m2, but in no case lower than the 30th percentile for age. Because CF patients are typically smaller than non-CF-patients, the normal body mass index will be based on standard CF foundation normal values for weight and sex.
Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period.
Patients and legal representatives must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures

Exclusion Criteria:

Patients with FEV1 < 35% of predicted. FEV1 (forced expiratory volume) is a measure of lung function. This exclusion will prohibit enrollment of patients with severely impaired lung function.
Patients with Burkholderia cepacia colonization of their respiratory tract
Patients with acute bronchopulmonary aspergillosis (ABPA)
Patients on a lung transplant list
Patients with acute pulmonary exacerbations
Patients with severe liver cirrhosis
Massive hemoptysis in the preceding 4 weeks
A history of relevant diseases of vital organs, of the central nervous system, or other organs not related to the underlying disease
Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
Patients with hypersensitivity to the investigational drug or to other quinolones and/ or to inactive constituents
Patients with known intolerance to hypertonic saline or bronchodilators
Concomitant inhalation therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones
Women who are pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Atlanta	Georgia	30322	United States

ID	Term
D011552	Pseudomonas Infections
D003550	Cystic Fibrosis
D053120	Respiratory Aspiration

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines