Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:6 - Any
Updated:1/6/2019
Start Date:June 27, 2018
End Date:June 27, 2019
Contact:Keri Vaughan
Email:keri.vaughan@mylan.com
Phone:+1 267.980.5015

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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

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

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.

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
We found this trial at
9
sites
1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
Principal Investigator: Maria Gabriela Tupayachi Ortiz
University of Miami Hospital The University of Miami changed the face of modern health care...
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Principal Investigator: Okan Elidemir
Phone: 850-505-4785
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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Miami, Florida 33136
Principal Investigator: Andrew Colin
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New Orleans, Louisiana 70112
Principal Investigator: Scott Davis
Phone: 401-741-7958
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New Orleans, LA
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Oklahoma City, Oklahoma 73104
Principal Investigator: Nighat Mehdi
Phone: 405-271-6216
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Oklahoma City, OK
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Oklahoma City, Oklahoma
Principal Investigator: Santiago Reyes
Phone: 405-945-4495
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Oklahoma City, OK
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13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
Principal Investigator: Shatha Yousef
Phone: 407-234-1740
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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Orlando, FL
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Richmond, Virginia 23298
Principal Investigator: Michael Schechter
Phone: 804-628-3093
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Richmond, VA
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Toledo, Ohio 43606
Principal Investigator: Bruce Barnett
Phone: 419-291-2949
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Toledo, OH
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