Cystic FibrosisPhase 3NCT00004829
Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis
A Phase 3 study testing tobramycin in people with Cystic Fibrosis and Bacterial Infection, run by FDA Office of Orphan Products Development.
Trial summary
OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa. II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis, Bacterial Infection
- What is being tested?
- tobramycin
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 1995to May 1998
- Phase
- Phase 3
- 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
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Documented cystic fibrosis with Pseudomonas aeruginosa present in a sputum or throat culture within 6 months prior to screening
Sweat chloride at least 60 mEq/L
--Prior/Concurrent Therapy--
At least 14 days since prior intravenous or aerosolized tobramycin or other antipseudomonal antibiotic
At least 4 weeks since prior administration of any investigational drug
No concurrent antibiotics by aerosol
--Patient Characteristics--
Renal:
- Creatinine less than 2 mg/dL
- BUN less than 40 mg/dL
- No proteinuria of 2+ or greater
Pulmonary:
- FEV1 at least 75% and at least 25% of predicted
- Room air oximetry at least 88% saturation
- Able to perform pulmonary function tests
- No hemoptysis of 60 mL or greater within 30 days prior to study
- No abnormal chest X-ray
Other:
- Not pregnant
- Fertile females must use effective contraception
- No history of positive culture with Burkholderia cepacia
- No history of glucose-6-phosphate dehydrogenase deficiency
- No known local or systemic hypersensitivity to aminoglycosides, albuterol, or other beta-2 agonists
About this study
OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa.
II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy.
Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.
- Conditions
- Cystic Fibrosis, Bacterial Infection
- Being tested
- tobramycin
- Keywords
- bacterial infection, cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, immunologic disorders and infectious disorders, rare disease
- Medical subject headings
- Cystic Fibrosis, Bacterial Infections, Respiratory Tract Diseases, Genetic Diseases, Inborn, Immune System Diseases, Communicable Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tobramycinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startJun 1995
- Study completionMay 1998
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- FDA Office of Orphan Products Development
- Sponsor type
- US federal agency
- Investigators
- Alan Bruce Montgomery, Study chair, Pathogenesis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004829
- Sponsor's protocol ID
- 199/13390
- Other IDs
- PATH-PG-TNDS-002/003, PATH-FDR001235
- Status last verified
- Jun 1998
- First submitted
- 24 Feb 2000
- Last updated
- 25 Mar 2015
- 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 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00004829
- Acronym / sponsor ID
- 199/13390
- Conditions
- Cystic Fibrosis, Bacterial Infection
- Keywords
- bacterial infection, cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, immunologic disorders and infectious disorders, rare disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- FDA Office of Orphan Products DevelopmentUS federal agency
- Study start
- Jun 1995
- Study completion
- May 1998
- First posted
- 25 Feb 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.
OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa.
II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy.
Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 | 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 25 Mar 2015.
- 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.
Alan Bruce Montgomery study chair
Pathogenesis
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tobramycin in people with Cystic Fibrosis and Bacterial Infection, run by FDA Office of Orphan Products Development.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Mar 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00004829, 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 25 Mar 2015.