Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00388505
• Date of registration: 16/10/2006
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis EAGER
• 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
• Date of first enrolment: February 2006
• Target sample size: 517
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00388505
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Chile, Colombia, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: Michael Konstan, MD
• Affiliation: University Hospitals Cleveland Medical Center

Key inclusion & exclusion criteria

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.

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



Age minimum: 6 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Tobramycin Solution for Inhalation

Drug: Tobramycin Inhalation Powder

Primary Outcome(s)

Number of Participants With Treatment-emergent Adverse Events [Time Frame: 25 weeks]

Secondary Outcome(s)

Antipseudomonal Antibiotic Usage During the Study [Time Frame: 25 Weeks]

Change From Baseline in Pseudomonas Aeruginosa Sputum Density [Time Frame: Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25).]

Change From Baseline in Tobramycin Minimum Inhibitory Concentration [Time Frame: Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)]

Hospitalization Due to Respiratory Events During the Study [Time Frame: 25 Weeks]

Percentage of Participants With a Decrease From Baseline in Auditory Acuity [Time Frame: Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21)]

Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1) [Time Frame: Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)]

Serum Tobramycin Concentrations [Time Frame: Weeks 1, 5, 17 and 21]

Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication [Time Frame: Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21).]

Secondary ID(s)

CTBM100C2302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/07/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00388505