Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

Novartis

Status and phase: Completed; Phase 4

Conditions: Pulmonary Infections; Pseudomonas Aeruginosa in Cystic Fibrosis

Treatments: Drug: TBM100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01519661

CTBM100C2401

2011-002000-32 (EudraCT Number)

Details and patient eligibility

About

This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

Enrollment: 157 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of Cystic Fibrosis
• FEV1 at screening must be between 25 and 75 percent of normal predicted values for age, sex and height based on the Knudson equation
• Pseudomonas aeruginosa must be present in a sputum / deep cough throat swab culture or bronchoalveolar lavage within 6 months prior to screening and in the sputum/deep-throat cough swab culture at screening

Exclusion criteria

• History of sputum culture or deep cough throat swab culture yielding Burkholderia cenocepacia complex within 2 years prior to screening and /or sputum culture yielding Burkholderia cenocepacia at screening
• Hemoptysis more than 60mL at any time within 30 days prior to study drug administration
• History of hearing loss or chronic tinnitus deemed clinically significant
• Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening
• Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
• Patients who are regularly receiving more than 1 class of inhaled anti-pseudomonal antibiotic
• Any use of inhaled or systemic anti-pseudomonal antibiotic within 28 days prior to study drug administration
• Use of loop diuretics within 7 days prior to study drug administration

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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157 participants in 1 patient group

Tobramycin Inhalation Powder (TIP)

Experimental group

Description:

Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.

Treatment:

Drug: TBM100