Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients

• Register: EUCTR
• Last refreshed on: 23 May 2016
• Main ID: EUCTR2016-001840-20-Outside-EU/EEA
• Date of registration: 18/05/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals Corporation
• Public title: Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients
• Scientific title: A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules.
• Target sample size: 45
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001840-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
•Male and female subjects aged 6 years and older at screening
•Confirmed diagnosis of CF
•Pulmonary function FEV1 value at least 25% of normal predicted values
•Must be physically and cognitively able to read, alone or with the assistance of their caregiver

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Subjects currently enrolled in studies that are not considered observational noninvestigational studies.
•Subjects who have used the Podhaler device previously
•Hemoptysis more than 60mL at any time within 30 days prior to study drug administration
•History of hypersensitivity to inhaled dry powder
•Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax



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

Health Condition(s) or Problem(s) studied

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

cystic fibrosis
MedDRA version: 19.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders

Intervention(s)

Trade Name: TOBI Podhaler
Pharmaceutical Form: Inhalation powder, hard capsule
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Primary end point(s): Safe and effective use of the podhaler device by CF patients

The primary variables of this study include:
- Completion status of placebo capsule use (pass/fail)
- Existence of a correlation between IFU and placebo capsule use completion status (yes/no)

Secondary Objective: Not applicable

Main Objective: To determine whether CF patients, representative of potential TOBI® Podhaler™ users, could understand and follow the approved IFU and the extent to which the approved IFU supports safe and effective use of the Podhaler device.

Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

CTBM100C2412

Source(s) of Monetary Support

Novartis Pharmaceuticals Corporation