Cystic FibrosisPhase 2NCT00006280
A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
A Phase 2 study testing Tobramycin for Inhalation in people with Cystic Fibrosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 9 sites in United States.
Trial summary
This study's primary goals are to test the safety and effectiveness of Tobramycin for Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of age. This drug is an antibiotic that is inhaled into the lungs by the patient. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Tobramycin for Inhalation
- How many people
- 98 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2000to Feb 2002
- Phase
- Phase 2
- 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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age at least 6 months and less than 6 years
- Diagnosis of cystic fibrosis with 2 clinical features consistent with CF and confirmed by either sweat chloride >= 60 mEq/L (by quantitative pilocarpine iontophoresis) or by genotype with 2 identifiable mutations consistent with CF.
- One throat or sputum microbiology culture positive for Pseudomonas aeruginosa (Pa) within 2 weeks to 12 months prior to screening.
- Informed consent by parent or legal guardian.
Who cannot join
- History of adverse reaction to anesthesia or sedation.
- History of aminoglycoside hypersensitivity.
- History of unresolved anemia (hematocrit < 30%) or thrombocytopenia (platelet count < 100,000/mm3).
- History of hemoptysis with 30 days prior to screening.
- History of abnormal renal function (serum creatinine > 1.5 times the upper limit of normal for age).
- History of clinically documented chronic hearing loss.
- Administration of any investigational drug within 30 days prior to screening.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Children's Hospital
Boston, Massachusetts, 02115
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
The Children's Hospital
Denver, Colorado, 80218
Baylor College of Medicine
Houston, Texas, 77030
Stanford University/Lucille Packard Children's Health Services at Stanford
Palo Alto, California, 94304
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
About this study
Official title: A Phase II Multicenter Randomized Trial of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
This study's primary goals are to test the safety and effectiveness of Tobramycin for Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung fluid will be examined for bacteria before and after the 28-day treatment. The amount of bacteria before and after treatment will be compared. This will indicate whether the antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr but contains no medication).
- Conditions
- Cystic Fibrosis
- Being tested
- Tobramycin for Inhalation
- Keywords
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobramycin for InhalationDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2000 (estimated)
- Study startFeb 2000
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 98 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- Jeffrey Wagener, M.D., Principal investigator, The Children's HospitalRichard Moss, M.D., Principal investigator, Stanford University/Lucille Packard Children's Health Services at StanfordRobert Wilmott, M.D., Principal investigator, Children's Hospital & Medical CenterMichael Konstan, M.D., Principal investigator, Rainbow Babies and Children's HospitalPamela Zeitlin, M.D., Ph.D., Principal investigator, Johns Hopkins UniversityDavid Waltz, M.D., Principal investigator, Children's Hospital Medical Center, CincinnatiGeorge Retsch-Bogart, M.D., Principal investigator, University of North Carolina, Chapel HillPeter Hiatt, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006280
- Sponsor's protocol ID
- Inhaled Tobramycin (completed)
- Other IDs
- 1R01DK057755-01, M01RR000037
- Status last verified
- Mar 2010
- First submitted
- 11 Sep 2000
- Last updated
- 2 Mar 2010
- Results posted
- No
Publications
Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, Vasiljev-K M, Borowitz D, Bowman CM, Marshall BC, Marshall S, Smith AL. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med. 1999 Jan 7;340(1):23-30. doi: 10.1056/NEJM199901073400104.
PubMed 9878641
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Randomized Trial of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00006280
- Acronym / sponsor ID
- Inhaled Tobramycin (completed)
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Feb 2000
- Study completion
- Feb 2002
- First posted
- 12 Sep 2000 (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 study's primary goals are to test the safety and effectiveness of Tobramycin for Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung fluid will be examined for bacteria before and after the 28-day treatment. The amount of bacteria before and after treatment will be compared. This will indicate whether the antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr but contains no medication).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age at least 6 months and less than 6 years
- Diagnosis of cystic fibrosis with 2 clinical features consistent with CF and confirmed by either sweat chloride >= 60 mEq/L (by quantitative pilocarpine iontophoresis) or by genotype with 2 identifiable mutations consistent with CF.
- One throat or sputum microbiology culture positive for Pseudomonas aeruginosa (Pa) within 2 weeks to 12 months prior to screening.
- Informed consent by parent or legal guardian.
Key exclusion criteria (7 listed)
- History of adverse reaction to anesthesia or sedation.
- History of aminoglycoside hypersensitivity.
- History of unresolved anemia (hematocrit < 30%) or thrombocytopenia (platelet count < 100,000/mm3).
- History of hemoptysis with 30 days prior to screening.
- History of abnormal renal function (serum creatinine > 1.5 times the upper limit of normal for age).
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 |
|---|---|---|
| Tobramycin for Inhalation | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Mar 2010.
- Background: PubMed 9878641Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, Vasiljev-K M, Borowitz D, Bowman CM, Marshall BC, Marshall S, Smith AL. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med. 1999 Jan 7;340(1):23-30. doi: 10.1056/NEJM199901073400104.
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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.
Jeffrey Wagener, M.D. principal investigator
The Children's Hospital
Richard Moss, M.D. principal investigator
Stanford University/Lucille Packard Children's Health Services at Stanford
Robert Wilmott, M.D. principal investigator
Children's Hospital & Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tobramycin for Inhalation in people with Cystic Fibrosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 9 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 4 inclusion and 7 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 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006280, which also lists 1 linked publication.
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 2 Mar 2010.