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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03502070
Recruitment Status : Completed
First Posted : April 18, 2018
Results First Posted : June 30, 2020
Last Update Posted : July 13, 2020
Information provided by (Responsible Party):
Mylan Inc.

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Placebo Device: Tobi Podhaler Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 26, 2018
Actual Primary Completion Date : March 19, 2019
Actual Study Completion Date : June 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Open-Label Placebo
One dose (4 capsules) of placebo
Drug: Placebo
One dose (4 capsules) of placebo

Device: Tobi Podhaler
The placebo capsule has to be released from the blister card and inserted into the Podhaler device. The device is then actuated and the study drug is inhaled according to the instructions for use

Primary Outcome Measures :
  1. Number of Participants With Critical Use Errors and Close Calls Associated With the Simulated Inhalation of One Dose Using TOBI Podhaler [ Time Frame: 1 Day ]
    Critical use errors and close calls for the following: placing of capsule into the top of the mouthpiece, failure to replace mouthpiece, failure to adequately pierce capsule, failure to release before inhaling, multiple piercing of capsule, exhalation into mouthpiece, inadequate seal around mouthpiece, inadequate inhalation technique, failure to use reserve device when capsule not adequately pierced, failure to administer 4 capsules per dose, swallowing of capsule

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03502070

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United States, Florida
Batchelor Childrens Research Institute
Miami, Florida, United States, 33136
University of Miami Hospital
Miami, Florida, United States, 33136
Nemours Childrens Hospital
Orlando, Florida, United States, 32827
Nemour's Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
United States, Louisiana
Tulane Lakeside Hospital for Women and Children
New Orleans, Louisiana, United States, 70112
United States, Ohio
Toledo Childrens Hospital
Toledo, Ohio, United States, 43606
United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
Respiratory Diseases of Children and Adolescents
Oklahoma City, Oklahoma, United States, 73112
United States, Virginia
VCU Children's Pavilion
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Mylan Inc.
  Study Documents (Full-Text)

Documents provided by Mylan Inc.:
Study Protocol  [PDF] November 12, 2018
Statistical Analysis Plan  [PDF] March 4, 2019

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Responsible Party: Mylan Inc. Identifier: NCT03502070    
Other Study ID Numbers: CTBM100C2419
First Posted: April 18, 2018    Key Record Dates
Results First Posted: June 30, 2020
Last Update Posted: July 13, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Mylan Inc.:
CF, Human Factors, TOBI® Podhaler™, user interface, IFU
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anti-Bacterial Agents
Anti-Infective Agents