Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
Completed · Phase 4 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
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
Key facts
- Study ID
- NCT03502070
- Run by
- Mylan Inc.
- People needed
- 47
- Starts
- 2018-06-26
- Expected to finish
- 2019-06-17
- Last updated by the study team
- 2022-03-03
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Batchelor Childrens Research Institute — Miami, Florida, United States
- University of Miami Hospital — Miami, Florida, United States
- Nemours Childrens Hospital — Orlando, Florida, United States
- Nemour's Children's Clinic - Pensacola — Pensacola, Florida, United States
- Tulane Lakeside Hospital for Women and Children — New Orleans, Louisiana, United States
- Toledo Childrens Hospital — Toledo, Ohio, United States
- University of Oklahoma Health Science Center — Oklahoma City, Oklahoma, United States
- Respiratory Diseases of Children and Adolescents — Oklahoma City, Oklahoma, United States
- VCU Children's Pavilion — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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