An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2012-003532-23-IT
• Date of registration: 21/12/2012
• Prospective Registration: Yes
• Primary sponsor: NOVARTIS FARMA
• Public title: An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis
• Scientific title: A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis
• Date of first enrolment: 18/01/2013
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003532-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1

Countries of recruitment

Argentina, Australia, Canada, Germany, Hungary, Italy, Mexico, Spain, United States

Contacts

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Farma

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Farma

Key inclusion & exclusion criteria

Inclusion criteria:
1. Provide written informed consent, HIPAA (Health Insurance Portability and Accountability Act) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure. 2. Completed the core study CTBM100C2401 and able to comply with all protocol requirements of the extension study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 93
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion criteria:
1. Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at entry into the extension study (visit 15). 2. Use of loop diuretics within 7 days prior to entry into the extension study. 3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG laboratory test (> 5 mIU/mL) at Visit 15. 4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using a highly effective method of contraception during dosing of study treatment as defined in full protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1 Level: PT Classification code 10057582 Term: Lung infection pseudomonal System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1 Level: PT Classification code 10011763 Term: Cystic fibrosis lung System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1 Level: HLT Classification code 10037132 Term: Pseudomonal infections System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Trade Name: TOBI PODHALER*448CPS 28MG+10IN
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Tobramycin
CAS Number: 32986-56-4
Current Sponsor code: TBM100C
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 28-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Across 12 cycles of treatment (core study and extension) and within the extension alone

Secondary Objective: To evaluate endpoints of interest across 12 cycles (6 treatment cycles in the core study and 6 treatment cycles in the extension study) of TIP treatment: • change in FEV1 % predicted (relative and absolute) • absolute change in P. aeruginosa CFU per gram of sputum • change of P. aeruginosa tobramycin MIC • time to first and the rate of the usage (overall, oral, intravenous) of antipseudomonal antibiotic (other than those regularly scheduled as prophylactic treatment) • time to first and the rate of hospitalization due to serious respiratoryrelated AEs • safety profile of TIP in terms of clinical laboratory results and audiology (in a sub-set of patients) • safety profile of TIP in terms of acute change in FEV1 from pre-dose to 30 minutes post dose • PLEASE SEE PROTOCOL

Main Objective: To assess the safety of Tobramycin Inhalation Powder (TIP) across 12 treatment cycles (6 treatment cycles in the core study and 6 treatment cycles in the extension study) in terms of the incidence of treatment emergent adverse events (AEs).

Primary end point(s): Incidence of treatment-emergent adverse event

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27 2) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27 3) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27 4) across 12 cycles of treatment (core study and extension) and within the extension alone 5) across 12 cycles of treatment (core study and extension) and within the extension alone 6) Evaluation of clinical laboratory results and (in selected study sites) audiology: across 12 cycles of treatment (core study and extension) and within the extension alone

Secondary end point(s): 1) Relative change in FEV1% predicted, FVC % predicted and FEF25-75 % predicted from baseline 2) Relative change in P aeruginosa CFU in sputum from baseline 3) Change in P aeruginosa tobramycin MIC from baseline 4) Rate of and time to the first hospitalization due to serious respiratoryrelated AE 5) Rate of and time to the first use of anti-pseudomonal antibiotics (overall, oral, intravenous) 6) Evaluation of clinical laboratory results and (in selected study sites) audiology

Secondary ID(s)

CTBM100C2401E1

2012-003532-23-HU

Source(s) of Monetary Support

Novartis