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

Completed · Phase 4 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT02178540

Run by

Novartis Pharmaceuticals

People needed

45

Starts

2014-08-01

Expected to finish

2015-02-01

Last updated by the study team

2016-05-23

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Long Beach, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Ventura, California, United States
• Novartis Investigative Site — Washington D.C., District of Columbia, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Toledo, Ohio, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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