Cystic FibrosisPhase 3EVOLVENCT00125346

Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

A Phase 3 study testing Tobramycin Inhalation Powder in people with Cystic Fibrosis, run by Novartis at 41 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 6 to 21 years
Conditions the study is for: Cystic Fibrosis
What is being tested?: Tobramycin Inhalation Powder
How many people: 98 participants
Where: 41 sitesin 8 countries
Study dates: Sep 2005to Feb 2007
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 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Confirmed diagnosis of cystic fibrosis patients with Pseudomonas aeruginosa infection.
Male and female subjects between 6 and 21 years of age at the time of screening.
FEV1 at screening must be between 25% and 80% of normal predicted values.

Who cannot join

Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

Trial locations and contacts

41 sites in 8 countries.

Country

City, postcode or hospital

41 sites in 8 countries

United States26 sites

For information on a site near you, call 1-800-244-7668 Option "2"
Ann Arbor, Michigan
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Atlanta, Georgia
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Augusta, Georgia
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Charleston, South Carolina
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Chicago, Illinois
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Cleveland, Ohio
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Columbus, Ohio
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Durham, North Carolina
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Fresno, California
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Long Beach, California
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Los Angeles, California
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Mobile, Alabama
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Morgantown, West Virginia
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New Hyde Park, New York
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New York, New York
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Oak Lawn, Illinois
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Oakland, California
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Oklahoma City, Oklahoma
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Orlando, Florida
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Pensacola, Florida
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Sacramento, California
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Salt Lake City, Utah
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Tyler, Texas
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Valhalla, New York

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Brazil3 sites

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Campinas, São Paulo
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Curitiba, Paraná
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Florianópolis, Santa Catarina

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Canada3 sites

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Hamilton, Ontario
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Sainte-Foy, Quebec
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Vancouver, British Columbia

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Mexico3 sites

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Mexico City
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Monterrey
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Tijuana

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Argentina2 sites

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Buenos Aires
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Córdoba

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Chile2 sites

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Santiago
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Viña del Mar

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Bulgaria1 site

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Varna

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Lithuania1 site

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Vilnius

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About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects

Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The purpose of this research study is to determine if TIP is safe and effective when compared to placebo (a powder with no medicine) treatment.

Conditions: Cystic Fibrosis
Being tested: Tobramycin Inhalation Powder
Keywords: Tobramycin Inhalation Powder
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 Inhalation PowderDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Forced expiratory volume in 1 second (FEV1) measured at week 1 and week 5.

Secondary outcomes (5)

Time until first antipseudomonal antibiotic (an antibiotic used to treat bacteria of a certain type [the genus pseudomonas]) is used
Relative changes in FEV1 % predicted for patients who received TIP starting at visit 1 and for patients who received placebo starting at week 9, compared to all subsequent visits.
Relative change in FEV1 % predicted for patients who received placebo from week 5 to week 13
Relative change in FEV1 % predicted for patients who received placebo (from the average of four assessments [weeks 1, 2, 5, and 9] to week 13)
Change from baseline in susceptibility of pseudomonas to the antibiotic during the study measured at weeks 5, 9, 13, 17, 21, and 25, and change from baseline in quantity of pseudomonas found in sputum during the study measured at weeks 5, 9, 13, 17, 21,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Feb 2007

First posted1 Aug 2005 (estimated)
Study startSep 2005
Primary completionFeb 2007
Study completionFeb 2007

Why it stopped: per Data Monitoring Committee recommendation

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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Masking: Double blind
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00125346
Sponsor's protocol ID: CTBM100C2301
Acronym: EVOLVE
Status last verified: Oct 2011
First submitted: 28 Jul 2005
Last updated: 12 Oct 2011
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete

All Cystic Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects
ClinicalTrials.gov ID: NCT00125346
Acronym / sponsor ID: EVOLVE / CTBM100C2301
Conditions: Cystic Fibrosis
Keywords: Tobramycin Inhalation Powder
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: per Data Monitoring Committee recommendation
Enrolment: 98 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Feb 2007 (actual)
Study completion: Feb 2007 (actual)
First posted: 1 Aug 2005 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Masking: Double blind

Who may qualify

Ages: 6 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Confirmed diagnosis of cystic fibrosis patients with Pseudomonas aeruginosa infection.
Male and female subjects between 6 and 21 years of age at the time of screening.
FEV1 at screening must be between 25% and 80% of normal predicted values.

Key exclusion criteria (1 listed)

Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

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 Inhalation Powder	Drug	–

Primary outcome

Forced expiratory volume in 1 second (FEV1) measured at week 1 and week 5.

5 secondary outcomes

Time until first antipseudomonal antibiotic (an antibiotic used to treat bacteria of a certain type [the genus pseudomonas]) is used
Relative changes in FEV1 % predicted for patients who received TIP starting at visit 1 and for patients who received placebo starting at week 9, compared to all subsequent visits.
Relative change in FEV1 % predicted for patients who received placebo from week 5 to week 13
Relative change in FEV1 % predicted for patients who received placebo (from the average of four assessments [weeks 1, 2, 5, and 9] to week 13)
Change from baseline in susceptibility of pseudomonas to the antibiotic during the study measured at weeks 5, 9, 13, 17, 21, and 25, and change from baseline in quantity of pseudomonas found in sputum during the study measured at weeks 5, 9, 13, 17, 21,

Results and safety

The study was stopped early (reason given: per Data Monitoring Committee recommendation). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.

Related trials for Cystic Fibrosis

RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete

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.

The record lists no contact. Use the official record to reach the sponsor.

41 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tobramycin Inhalation Powder in people with Cystic Fibrosis, run by Novartis at 41 sites in 8 countries.

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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Brazil, Canada, Mexico, Argentina and 3 more countries. 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 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 was stopped early (reason given: per Data Monitoring Committee recommendation). Results are not available in the source record.

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?

Forced expiratory volume in 1 second (FEV1) measured at week 1 and week 5.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00125346.

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 12 Oct 2011.