Pseudomonas InfectionPhase 1NCT00910351
Cipro Inhaler for Cystic Fibrosis Children Ages 6-12
A Phase 1 study testing Ciprofloxacin (Cipro, BAYQ3939) in people with Pseudomonas Infection, run by Bayer at 4 sites in United States.
Trial summary
Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation. This planned study is the first study on the use of this new Ciprofloxacin PulmoSphere Inhalation Powder in the pediatric population of 6 to 12 years of… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pseudomonas Infection
- What is being tested?
- Ciprofloxacin (Cipro, BAYQ3939)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2009to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Atlanta, Georgia, 30322
Study site
Baltimore, Maryland, 21287
Study site
Boston, Massachusetts, 02115
Study site
Syracuse, New York, 13210
About this study
Official title: A Study to Evaluate the Safety and Pharmacokinetics of Ciprofloxacin in Adults and Children Aged 6 - 12 Years With Cystic Fibrosis Following Inhalation of Ciprofloxacin Dry Powder
Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation. This planned study is the first study on the use of this new Ciprofloxacin PulmoSphere Inhalation Powder in the pediatric population of 6 to 12 years of age.
- Conditions
- Pseudomonas Infection
- Being tested
- Ciprofloxacin (Cipro, BAYQ3939)
- Keywords
- Cystic Fibrosis, Pharmacokinetics, Pediatrics, Inhalation, Sputum
- Medical subject headings
- Pseudomonas Infections, Cystic Fibrosis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin (Cipro, BAYQ3939)Drug
25 mg inhaled Ciprofloxacin
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Ciprofloxacin (Cipro, BAYQ3939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF patients, aged 6 - 12 years
Measured: Two weeks post screening
Secondary outcomes (1)
To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomonas InfectionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910351
- Sponsor's protocol ID
- 12759
- Status last verified
- Nov 2013
- First submitted
- 28 May 2009
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Pharmacokinetics of Ciprofloxacin in Adults and Children Aged 6 - 12 Years With Cystic Fibrosis Following Inhalation of Ciprofloxacin Dry Powder
- ClinicalTrials.gov ID
- NCT00910351
- Acronym / sponsor ID
- 12759
- Conditions
- Pseudomonas Infection
- Keywords
- Cystic Fibrosis, Pharmacokinetics, Pediatrics, Inhalation, Sputum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ciprofloxacin PulmoSphere Inhalation Powder appears to be an effective and adequate antibiotic treatment for cystic fibrosis patients with P. aeruginosa colonisation. This planned study is the first study on the use of this new Ciprofloxacin PulmoSphere Inhalation Powder in the pediatric population of 6 to 12 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Ciprofloxacin (Cipro, BAYQ3939) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofloxacin (Cipro, BAYQ3939)25 mg inhaled Ciprofloxacin | Drug | Arm 1 |
Primary outcome
To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF patients, aged 6 - 12 years
Time frame: Two weeks post screening
1 secondary outcome
To investigate the pharmacokinetics of ciprofloxacin in plasma and sputum after inhalation administration
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ciprofloxacin (Cipro, BAYQ3939) in people with Pseudomonas Infection, run by Bayer at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF patients, aged 6 - 12 years (time frame: Two weeks post screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.