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

NCT03502070 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: CTBM100C2419
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 9

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

Conditions

Cystic Fibrosis

Keywords

CF, Human Factors, TOBI® Podhaler™, user interface, IFU

Outcome Measures

Primary Outcomes (1)

• 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

  1 Day

Study Arms (1)

Open-Label Placebo

OTHER

One dose (4 capsules) of placebo

Drug: Placebo; Device: Tobi Podhaler

Interventions

Placebo DRUG

One dose (4 capsules) of placebo

Open-Label Placebo

Tobi Podhaler DEVICE

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

Open-Label Placebo

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mylan Inc.: lead

Study Sites (9)

Batchelor Childrens Research Institute

Miami, Florida, 33136, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Nemours Childrens Hospital

Orlando, Florida, 32827, United States

Location

Nemour's Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States

Location

Tulane Lakeside Hospital for Women and Children

New Orleans, Louisiana, 70112, United States

Location

Toledo Childrens Hospital

Toledo, Ohio, 43606, United States

Location

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Respiratory Diseases of Children and Adolescents

Oklahoma City, Oklahoma, 73112, United States

Location

VCU Children's Pavilion

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Keri L Vaughan
• Organization: Director Global Clinical Operations, General Medicine

keri.vaughan@mylan.com

+1 267.980.5015

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 18, 2018
• Study Start: June 26, 2018
• Primary Completion: March 19, 2019
• Study Completion: June 17, 2019
• Last Updated: March 3, 2022
• Results First Posted: June 30, 2020

Record last verified: 2022-03

Locations

US (9)