Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients
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
1 other identifier
interventional
45
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2014
Shorter than P25 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
June 30, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
May 23, 2016
CompletedMay 23, 2016
April 1, 2016
6 months
June 24, 2014
August 6, 2015
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Recording all use errors and close calls associated with inhalation of one dose of TOBI Podhaler (i.e., inhaling the contents of four placebo capsules via the Podhaler device) by subjects (CF patients, and caregivers, if applicable). The study population consisted of CF patients (and caregivers) naïve to the Podhaler device and untrained in the use of the device. Assessing the root cause of use errors and close calls for 6 defined critical errors (agreed with the FDA) and establishing those which can be attributed to a lack of clarity or presence of ambiguities in the IFU content, i.e., errors attributable to a failure to understand the IFU.
1 Day
Study Arms (1)
Open label
OTHERone dose (4 capsules) of placebo
Interventions
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
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Novartis Investigative Site
Phoenix, Arizona, 85016, United States
Novartis Investigative Site
Long Beach, California, 90806, United States
Novartis Investigative Site
Los Angeles, California, 90027, United States
Novartis Investigative Site
Ventura, California, 93003, United States
Novartis Investigative Site
Washington D.C., District of Columbia, 20010-2120, United States
Novartis Investigative Site
Jacksonville, Florida, 32207, United States
Novartis Investigative Site
Chicago, Illinois, 60611, United States
Novartis Investigative Site
New York, New York, 10595, United States
Novartis Investigative Site
Toledo, Ohio, 43606, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, 73104, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, 73112, United States
Novartis Investigative Site
Portland, Oregon, 97239, United States
Novartis Investigative Site
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Participating patients were naïve to the Podhaler device, and untrained in its use. Patients accessed only the approved IFU document. Open label study using placebo only, potentially impacting perception of need to complete tasks fully.
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2014
First Posted
June 30, 2014
Study Start
August 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
May 23, 2016
Results First Posted
May 23, 2016
Record last verified: 2016-04