Phase 4
Completed N=45
Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients
Source: ClinicalTrials.gov NCT02178540 ↗Enrolled (actual)
45
Serious AEs
2.2%
Results posted
May 2016
Primary outcomePrimary: The Use of the Approved US TOBI Podhaler Instructions for Use (IFU) to Communicates the Information Necessary to Achieve Safe and Effective Use of the Podhaler Device — 0; 0; 0; 3 Patients failing to understand IFU
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this actual use human factors (HF) study is to validate the approved US TOBI Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates the information necessary to achieve safe and effective use of the Podhaler device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Use of the Approved US TOBI Podhaler Instructions for Use (IFU) to Communicates the Information Necessary to Achieve Safe and Effective Use of the Podhaler Device |
0; 0; 0; 3; 0; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects aged 6 years and older at screening
- Confirmed diagnosis of CF
- Pulmonary function FEV1 value at least 25% of normal predicted values
- Must be physically and cognitively able to read, alone or with the assistance of their caregiver
Exclusion Criteria
- Subjects currently enrolled in studies that are not considered observational noninvestigational studies.
- Subjects who have used the Podhaler device previously
- Hemoptysis more than 60mL at any time within 30 days prior to study drug administration
- History of hypersensitivity to inhaled dry powder
- Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax
Data sourced from ClinicalTrials.gov (NCT02178540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.