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

Novartis

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: Tobramycin Solution for Inhalation; Drug: Tobramycin Inhalation Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00388505

CTBM100C2302

Details and patient eligibility

About

This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

Enrollment: 517 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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517 participants in 2 patient groups

Tobramycin inhalation powder (TIP)

Experimental group

Description:

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.

Treatment:

Drug: Tobramycin Inhalation Powder

Tobramycin solution for inhalation (TOBI)

Active Comparator group

Description:

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:

Drug: Tobramycin Solution for Inhalation