Clinical trial NCT03502070: Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
Official title: A Multicenter, Human Factors Validation Study in Cystic Fibrosis Patients Aged 6 Years and Older to Evaluate the User Interface of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: CF, Human Factors, TOBI® Podhaler™, user interface, IFU
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 47
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users

Detailed description: The objective is to conduct a human factors validation study to demonstrate that the user interface of TOBI® Podhaler™ can support safe and effective use for the intended users. The human factors validation study will be conducted in patients with cystic fibrosis aged 6 years and older under simulated yet representative of realistic use conditions where patients with no prior training or use of TOBI® Podhaler™ will be asked to inhale the contents of placebo capsules through the Podhaler device. Due to the use of placebo capsules, the study is considered an interventional clinical study and will be conducted accordingly. The study is an open label, un-blinded, non-randomized study which consists of one visit.

Eligibility criteria: Inclusion Criteria:

* Written informed consent or, parent/guardian consent and where applicable pediatric assent, must be obtained before any assessment is performed
* Male and female subjects aged 6 years and older
* Confirmed diagnosis of CF by one or more of the following tests for CF as documented in the patient's medical history : (1) quantitative pilocarpine iontophoresis sweat chloride test of \> 60 mmol/L or 60 mEq/L, (2) genotype with identifiable CF-causing mutations on both chromosomes, (3) an abnormal nasal transepithelial potential difference characteristic of CF
* FEV1 value must be at least 25% of normal predicted values for age, sex, and height as documented in the patient's medical history (historical values within 3 months can be used for this criterion).
* Able to comply with all protocol requirements
* Clinically stable in the opinion of the investigator

Exclusion Criteria:

* Subjects currently enrolled in studies that are not considered as observational non-investigational studies
* Subjects or caregivers who have used the Podhaler device previously
* Hemoptysis more than approximately 60 mL at any time within 30 days prior to enrollment
* History of hypersensitivity to the inhaled placebo dry powder (DSPC and/or calcium chloride powder)
* Signs and symptoms of acute pulmonary disease, e.g. pneumonia, pneumothorax, bronchospasm, acute respiratory infection
* Clinically significant conditions or findings at enrollment that might interfere with the accurate and valid assessment of this study
* Subjects or caregivers who are considered potentially unreliable or considered unlikely to be compliant within the trial
* Pregnant women

Primary outcomes:
measure: Number of Participants With Critical Use Errors and Close Calls Associated With the Simulated Inhalation of One Dose Using TOBI Podhaler
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Batchelor Childrens Research Institute
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Orlando
country: United States
facility: Nemours Childrens Hospital
state: Florida
city: Pensacola
country: United States
facility: Nemour's Children's Clinic - Pensacola
state: Florida
city: New Orleans
country: United States
facility: Tulane Lakeside Hospital for Women and Children
state: Louisiana
city: Toledo
country: United States
facility: Toledo Childrens Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Respiratory Diseases of Children and Adolescents
state: Oklahoma
city: Richmond
country: United States
facility: VCU Children's Pavilion
state: Virginia
Study officials:
References: