Cystic FibrosisNCT01319253
A Comparator Study Evaluating Microbiological Resistance and Effects of Alternating Inhaled Antibiotic Therapies
An observational study of Cystic Fibrosis and Pseudomonas Aeruginosa, run by Indiana University at 1 site in United States.
Trial summary
This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that alternation therapy will result in a decreased… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis, Pseudomonas Aeruginosa
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- > or = to 6 years of age
- Documentation of Cf diagnosis
- History of PA present in sputum, on a least one occasion, during the 12 months prior to Visit 1.
- Currently on inhaled antibiotic regiment
- Must be able to provide written informed consent or assent prior to any study related procedures
- Ability to expectorate sputum
- Ability ro perform reproducible pulmonary function test
Who cannot join
- Administration of any IV or oral antipseudomonal antibiotic within 28 days prior to Visit 1
- Any serious or active medical or psychiatric illness, which in the opinion of the investigator, woud interfere with participant treatment, assessment, or compliance with the protocol
- Current enrollment in an interventional clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparator Trial Evaluating Microbiological Resistance and Clinical Efficacy in Patients Using Alternation Therapy of Inhaled Antibiotics
This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing clinical and microbiological parameters.
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa
- Keywords
- Cystic Fibrosis, Pseudomonas aeruginosa
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cayston Only Cohort | This cohort will be on a previously established medication regiment of Cayston inhaled antibiotic alternating regimen every other month. | |
| Tobi Only Cohort | This Cohort will be on a previously established medication regiment that includes Tobi inhaled antibiotic regimen alternating every other month. | |
| Cayston and Tobi Cohort | This Cohort will be on a previously established medication regiment that includes Cayston and Tobi inhaled antibiotic alternating every other month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic Resistance Profiles
The primary endpoint will be a change in the microbial resistance profile of pseudomonas aeruginosa (PA)isolates, change in PA sputum density, minimum inhibitory concentration of aztreonam and tobramycin for PA and the appearance or disappearance of other pathogens.
Measured: Every three months within a 12 month period
Secondary outcomes (1)
Clinical Symptoms
Secondary endpoint will be the change in clinical symptoms as assessed by the respiratory symptoms domain of the Cystic Fibrosis Questionnaire -Revised (CFQ-R),changes in pulmonary function Forced Exhaled Volume 1 second (FEV1) and change in frequency of hospitalizations or need for intravenous antibiotics.
Measured: Every 3 months within a 12 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionOct 2015
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Michelle Howenstine, Indiana University
- Investigators
- Michelle S Howenstine, MD, Principal investigator, Indiana UniversityGregory Anderson, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319253
- Sponsor's protocol ID
- HOWEN-ANDER-001
- Status last verified
- Nov 2015
- First submitted
- 18 Mar 2011
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparator Trial Evaluating Microbiological Resistance and Clinical Efficacy in Patients Using Alternation Therapy of Inhaled Antibiotics
- ClinicalTrials.gov ID
- NCT01319253
- Acronym / sponsor ID
- HOWEN-ANDER-001
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa
- Keywords
- Cystic Fibrosis, Pseudomonas aeruginosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Mar 2011 (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 pilot study of inhaled antibiotic regimens is a pilot study examining clinical and laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing clinical and microbiological parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cayston Only Cohort | – | –This cohort will be on a previously established medication regiment of Cayston inhaled antibiotic alternating regimen every other month. |
| Tobi Only Cohort | – | –This Cohort will be on a previously established medication regiment that includes Tobi inhaled antibiotic regimen alternating every other month. |
| Cayston and Tobi Cohort | – | –This Cohort will be on a previously established medication regiment that includes Cayston and Tobi inhaled antibiotic alternating every other month |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (7 listed)
- > or = to 6 years of age
- Documentation of Cf diagnosis
- History of PA present in sputum, on a least one occasion, during the 12 months prior to Visit 1.
- Currently on inhaled antibiotic regiment
- Must be able to provide written informed consent or assent prior to any study related procedures
Key exclusion criteria (3 listed)
- Administration of any IV or oral antipseudomonal antibiotic within 28 days prior to Visit 1
- Any serious or active medical or psychiatric illness, which in the opinion of the investigator, woud interfere with participant treatment, assessment, or compliance with the protocol
- Current enrollment in an interventional clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antibiotic Resistance Profiles
Time frame: Every three months within a 12 month period
The primary endpoint will be a change in the microbial resistance profile of pseudomonas aeruginosa (PA)isolates, change in PA sputum density, minimum inhibitory concentration of aztreonam and tobramycin for PA and the appearance or disappearance of other pathogens.
1 secondary outcome
Clinical Symptoms
Time frame: Every 3 months within a 12 month period
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 6 Nov 2015.
Related trials for Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Not yet recruitingObservational study
Type 2 Inflammation in Adults With Cystic Fibrosis
Cystic Fibrosis (CF), Type 2 Inflammatory Disorders
Active, not recruitingObservational study
Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care
Cystic Fibrosis (CF), Non Cystic Fibrosis Bronchiectasis
RecruitingObservational study
A Precision Medicine Approach to Assess Protein Function Loss and the Potential for CFTR Function Restoration in Cystic Fibrosis and Related Disorders
Cystic Fibrosis (CF)
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.
Michelle S Howenstine, MD principal investigator
Indiana University
Gregory Anderson, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Pseudomonas Aeruginosa, run by Indiana University at 1 site 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 3 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 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Antibiotic Resistance Profiles (time frame: Every three months within a 12 month period). 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 6 Nov 2015; AzTrials last refreshed its copy on 26 Oct 2026.