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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02178540
• Other study ID #: CTBM100C2412
• Status: Recruiting
• Phase: Phase 4
• First received: June 24, 2014
• Last updated: October 3, 2014
• Start date: August 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2014
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Placebo
one dose (4 capsules) of placebo

Device:
• Tobi Podhaler
The capsule containing the study medication has to be released from the blister card, be inserted into the Podhaler device, actuated and the study drug be inhaled according to instructions for use

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Boise	Idaho
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Long Beach	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Milwaukee	Wisconsin
United States	Novartis Investigative Site	Morristown	New Jersey
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Sioux Falls	South Dakota
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	Toledo	Ohio
United States	Novartis Investigative Site	Ventura	California
United States	Novartis Investigative Site	Washington	District of Columbia
United States	Novartis Investigative Site	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safe and effective use of the podhaler device by CF patients	The primary variables of this study include (1) Completion status of placebo capsule use (pass/fail) (2) Existence of a correlation between IFU and placebo capsule use completion status (yes/no).	1 year	No