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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Tobi Podhaler
Sponsored by
Mylan Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cystic Fibrosis focused on measuring CF, Human Factors, TOBI® Podhaler™, user interface, IFU

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Batchelor Childrens Research Institute
  • University of Miami Hospital
  • Nemours Childrens Hospital
  • Nemour's Children's Clinic - Pensacola
  • Tulane Lakeside Hospital for Women and Children
  • Toledo Childrens Hospital
  • University of Oklahoma Health Science Center
  • Respiratory Diseases of Children and Adolescents
  • VCU Children's Pavilion

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open-Label Placebo

Arm Description

One dose (4 capsules) of placebo

Outcomes

Primary Outcome Measures

Number of Participants With Critical Use Errors and Close Calls Associated With the Simulated Inhalation of One Dose Using TOBI Podhaler
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

Secondary Outcome Measures

Full Information

First Posted
March 29, 2018
Last Updated
March 1, 2022
Sponsor
Mylan Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03502070
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
March 19, 2019 (Actual)
Study Completion Date
June 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
CF, Human Factors, TOBI® Podhaler™, user interface, IFU

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Placebo
Arm Type
Other
Arm Description
One dose (4 capsules) of placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One dose (4 capsules) of placebo
Intervention Type
Device
Intervention Name(s)
Tobi Podhaler
Intervention Description
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 Measure Information:
Title
Number of Participants With Critical Use Errors and Close Calls Associated With the Simulated Inhalation of One Dose Using TOBI Podhaler
Description
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
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Batchelor Childrens Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Nemours Childrens Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Nemour's Children's Clinic - Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Tulane Lakeside Hospital for Women and Children
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Toledo Childrens Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Respiratory Diseases of Children and Adolescents
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
VCU Children's Pavilion
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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

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