Cystic FibrosisNCT01090908
Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa
An observational study of Cystic Fibrosis, run by Aradigm Corporation.
Trial summary
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Antibiotic
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Jun 2011
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatrics
Who may be able to join
- 6 to 17 years of age (inclusive) at Visit 1.
- Positive sputum culture for P. aeruginosa
- Clinical diagnosis of CF
- FEV1 greater than or equal to 40% predicted normal lung function
- Able to perform spirometry testing reproducibly according to ATS guidelines.
Who cannot join
- Use of an investigational agent within 30 days prior to Visit 1 (first dosing visit).
- History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B. cepacia), within 2 years prior to screening and/or sputum culture yielding B. cepacia at the Screening visit;
- Use of any nebulized or systemic antibiotics within 14 days prior to Visit 1, other than maintenance oral macrolides that has been consistently used for at least 28 days prior to Visit 1.
- History of intolerance or hypersensitivity to quinolone or fluoroquinolone class antibiotics
- History of lung transplantation.
- AST, ALT or total bilirubin > 3 x upper limit of normal at screening.
- History of hemoptysis > 30 cc per episode during the 28 days prior to Visit 1.
- Other present conditions, abnormality in screening laboratory tests or physical examination findings, that in the opinion of the Investigator or Medical Monitor would compromise the safety of the patient or the quality of the data.
About this study
Official title: A Multi-Center, Open Label Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Ciprofloxacin For Inhalation (CFI) Given Daily For 14 Days To Stable Cystic Fibrosis Patients Ages 6 To 17 With Pseudomonas Aeruginosa
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection.
Read the detailed description
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection. Patients will be enrolled and followed in this study for 1 month. This study will consist of a Screening Phase, a Treatment Phase consisting of a 14 days, and a Follow up Phase consisting of a 14 days Off-treatment Period.
- Conditions
- Cystic Fibrosis
- Being tested
- Antibiotic
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
| Study group | Role | What they receive |
|---|---|---|
| Ages 6-11 years | Not described Receives: Drug: Antibiotic | |
| Ages 12-17 years | Not described Receives: Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum pharmacokinetics
Measured: Day 1
Secondary outcomes (3)
Microbiological efficacy
Measured: Day 14
Changes in spirometry
Measured: Days 1, 7, 14
Quality of life (CFQ-R)
Measured: Days 1, 7, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aradigm Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- P Bruinenber, MD, Study director, Aradigm Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090908
- Sponsor's protocol ID
- ARD-3100-1001
- Status last verified
- Aug 2012
- First submitted
- 11 Mar 2010
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open Label Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Ciprofloxacin For Inhalation (CFI) Given Daily For 14 Days To Stable Cystic Fibrosis Patients Ages 6 To 17 With Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT01090908
- Acronym / sponsor ID
- ARD-3100-1001
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aradigm CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 23 Mar 2010 (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.
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection.
Detailed description
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection. Patients will be enrolled and followed in this study for 1 month. This study will consist of a Screening Phase, a Treatment Phase consisting of a 14 days, and a Follow up Phase consisting of a 14 days Off-treatment Period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ages 6-11 years | – | Drug: Antibiotic |
| Ages 12-17 years | – | Drug: Antibiotic |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatrics
Key inclusion criteria (5 listed)
- 6 to 17 years of age (inclusive) at Visit 1.
- Positive sputum culture for P. aeruginosa
- Clinical diagnosis of CF
- FEV1 greater than or equal to 40% predicted normal lung function
- Able to perform spirometry testing reproducibly according to ATS guidelines.
Key exclusion criteria (8 listed)
- Use of an investigational agent within 30 days prior to Visit 1 (first dosing visit).
- History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B. cepacia), within 2 years prior to screening and/or sputum culture yielding B. cepacia at the Screening visit;
- Use of any nebulized or systemic antibiotics within 14 days prior to Visit 1, other than maintenance oral macrolides that has been consistently used for at least 28 days prior to Visit 1.
- History of intolerance or hypersensitivity to quinolone or fluoroquinolone class antibiotics
- History of lung transplantation.
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 |
|---|---|---|
| Antibiotic | Drug | Ages 12-17 years, Ages 6-11 years |
Primary outcome
Serum pharmacokinetics
Time frame: Day 1
3 secondary outcomes
Microbiological efficacy
Time frame: Day 14
Changes in spirometry
Time frame: Days 1, 7, 14
Quality of life (CFQ-R)
Time frame: Days 1, 7, 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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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.
P Bruinenber, MD study director
Aradigm Corporation
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Aradigm Corporation.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Serum pharmacokinetics (time frame: Day 1). 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 22 Nov 2023.