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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00388505
Registration number
NCT00388505
Ethics application status
Date submitted
16/10/2006
Date registered
17/10/2006
Date last updated
24/07/2012
Titles & IDs
Public title
Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis
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Scientific title
A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects
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Secondary ID [1]
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CTBM100C2302
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Universal Trial Number (UTN)
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Trial acronym
EAGER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Cystic fibrosis
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Respiratory
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tobramycin Inhalation Powder
Treatment: Drugs - Tobramycin Solution for Inhalation
Experimental: Tobramycin inhalation powder (TIP) - Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
Active Comparator: Tobramycin solution for inhalation (TOBI) - Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
Treatment: Drugs: Tobramycin Inhalation Powder
Tobramycin Inhalation Powder (TIP) capsules for inhalation.
Treatment: Drugs: Tobramycin Solution for Inhalation
Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-emergent Adverse Events
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Assessment method [1]
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An adverse event (AE) is any untoward medical occurrence, including any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication that does not necessarily have a causal relationship with study medication. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability, is a congenital anomaly or defect, or is a significant medical event that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.
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Timepoint [1]
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25 weeks
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Secondary outcome [1]
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Serum Tobramycin Concentrations
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Assessment method [1]
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Serum tobramycin concentrations were measured in a subset of participants at Week 1 (start of cycle 1), Week 5 (End of Cycle 1), Week 17 (start of cycle 3) and Week 21 (end of cycle 3). Serum samples were collected at pre-dose and post-dose at specified intervals; one specimen between 0 to 2 hours; two additional specimens between 2 and 5 hours (sample times must have been a minimum of 2 hours apart).
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Timepoint [1]
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Weeks 1, 5, 17 and 21
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Secondary outcome [2]
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Percentage of Participants With a Decrease From Baseline in Auditory Acuity
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Assessment method [2]
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Audiology testing was performed only at selected centers. Auditory acuity was measured from 250 to 8000 Hertz using a standard dual-channel audiometer.
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Timepoint [2]
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Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21)
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Secondary outcome [3]
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Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1)
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Assessment method [3]
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Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is then converted to a percentage of normal (percent predicted) based on height, weight, and race. FEV1 was measured at Baseline (prior to beginning study treatment) and predose on Day 28 of Cycles 1, 2 and 3 and at the follow-up visit.
Relative change = 100 * ((Day 28 of Cycle 3 value - Baseline value)/ Baseline value).
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Timepoint [3]
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Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)
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Secondary outcome [4]
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Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication
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Assessment method [4]
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Patient's self-reported treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM, a validated instrument) which was modified by adding four study-specific questions; the standard fourteen questions of the TSQM were not altered. Responses to nearly all items are rated on a five-point or seven-point rating scale and the items are factored into 4 domains. The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that domain.
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Timepoint [4]
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Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21).
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Secondary outcome [5]
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Change From Baseline in Pseudomonas Aeruginosa Sputum Density
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Assessment method [5]
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Three Pseudomonas aeruginosa biotypes were assessed in patient's sputum; mucoid, dry and small colony variant. Overall density is defined as the sum of all bio-types in Pseudomonas aeruginosa density.
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Timepoint [5]
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Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25).
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Secondary outcome [6]
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Change From Baseline in Tobramycin Minimum Inhibitory Concentration
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Assessment method [6]
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The minimum inhibitory concentration (MIC) is the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after overnight incubation. The MIC of tobramycin against total Pseudomonas aeruginosa colonization was assessed over the course of the study.
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Timepoint [6]
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Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)
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Secondary outcome [7]
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Antipseudomonal Antibiotic Usage During the Study
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Assessment method [7]
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The average number of days patients required antipseudomonal antibiotics during the course of the study.
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Timepoint [7]
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25 Weeks
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Secondary outcome [8]
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Hospitalization Due to Respiratory Events During the Study
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Assessment method [8]
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The average number of days patients were hospitalized due to respiratory events during the course of the study.
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Timepoint [8]
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25 Weeks
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Eligibility
Key inclusion criteria
- Confirmed diagnosis of cystic fibrosis
- Male and female patients at least 6 years of age at the time of screening.
- Forced expiratory volume in one second (FEV1) at screening must be at least 25% and
less than or equal to 75% of normal predicted values for age, sex, and height based on
Knudson criteria.
- Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat
cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to
screening and in the sputum/ deep-throat cough swab culture at the screening visit.
- Able to comply with all protocol requirements.
- Clinically stable in the opinion of the investigator.
- Use of an effective means of contraception in females of childbearing potential.
- Provide written informed consent, Health Authority Portability and Accountability Act
(HIPAA) authorization (where applicable), and assent (as appropriate) prior to the
performance of any study-related procedure.
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Minimum age
6
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of sputum culture or deep-throat cough swab (or BAL) culture yielding
Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to
screening and/or sputum culture yielding B cepacia at screening.
- Coughing up more than 60 cc of blood from the respiratory tract at any time within 30
days prior to study drug administration.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- Females who are pregnant (positive pregnancy test), lactating, or are planning to
become pregnant during the study.
- History of hearing loss or chronic ringing in the ears deemed clinically significant
by the investigator.
- Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study
drug administration.
- Use of loop diuretics within 7 days prior to study drug administration.
- Use of any investigational treatment within 28 days prior to study drug
administration.
- Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or
inhaled corticosteroids within 28 days prior to study drug administration (patients
may be taking these therapies at the time of enrollment, but they must have initiated
treatment more than 28 days prior to study drug administration).
Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2006
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
1/03/2009
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Sample size
Target
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Accrual to date
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Final
517
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative Site - South Brisbane
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Recruitment postcode(s) [1]
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- South Brisbane
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Recruitment outside Australia
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United States of America
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Connecticut
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Georgia
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Illinois
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Kentucky
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Massachusetts
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Calgary
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Canada
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Hamilton
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Ste-Foy
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Canada
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Essen
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Frankfurt
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Monterrey Nuevo Leon
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Groesbeek
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Rotterdam
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Barcelona
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Madrid
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Malaga
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Valencia
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Belfast
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Birmingham
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Cambridge
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Leeds
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London
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study compares the safety of the tobramycin solution for inhalation with the tobramycin
dry powder formulation, used with a simple inhaler
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00388505
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael Konstan, MD
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Address
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University Hospitals Cleveland Medical Center
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00388505
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