Clinical trial NCT02178540: Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: Human factors, TOBI® Podhaler™, Instructions For use, IFU, CF patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-06-30
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this actual use human factors (HF) study is to validate the approved US TOBI Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates the information necessary to achieve safe and effective use of the Podhaler device.

Detailed description: The objective of the HF study is to determine whether cystic fibrosis patients in the US, representative of potential TOBI Podhaler users, can understand and follow the approved IFU and the extent to which the approved IFU supports safe and effective use of the Podhaler device.

This study is an 'actual use' study, in that patients will inhale the contents of placebo capsules through the Podhaler device.

Due to the use of placebo capsules, the study is considered a clinical study and will be conducted accordingly. The study is therefore a human factors observational use study conducted within a clinical study. It is an open label, unblinded, non-randomized study and consists of two visits. At visit 2 patients who are eligible will participate in a human factor assessment to determine whether or not a patient understands the IFU content and can demonstrate safe and effective use of the Podhaler device.

Eligibility 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

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

Primary outcomes:
measure: The Use of the Approved US TOBI Podhaler Instructions for Use (IFU) to Communicates the Information Necessary to Achieve Safe and Effective Use of the Podhaler Device
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Long Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Ventura
country: United States
facility: Novartis Investigative Site
state: California
city: Washington
country: United States
facility: Novartis Investigative Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Toledo
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: