Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients
NCT ID: NCT02178540
Last Updated: 2016-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
45 participants
INTERVENTIONAL
2014-08-31
2015-02-28
Brief Summary
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Detailed Description
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This study is an 'actual use' study, in that patients will inhale the contents of placebo capsules through the Podhaler device.
Due to the use of placebo capsules, the study is considered a clinical study and will be conducted accordingly. The study is therefore a human factors observational use study conducted within a clinical study. It is an open label, unblinded, non-randomized study and consists of two visits. At visit 2 patients who are eligible will participate in a human factor assessment to determine whether or not a patient understands the IFU content and can demonstrate safe and effective use of the Podhaler device.
Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Open label
one dose (4 capsules) of placebo
Placebo
one dose (4 capsules) of placebo
Tobi Podhaler
The capsule containing the study medication has to be released from the blister card, be inserted into the Podhaler device, actuated and the study drug be inhaled according to instructions for use
Interventions
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Placebo
one dose (4 capsules) of placebo
Tobi Podhaler
The capsule containing the study medication has to be released from the blister card, be inserted into the Podhaler device, actuated and the study drug be inhaled according to instructions for use
Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Long Beach, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Ventura, California, United States
Novartis Investigative Site
Washington D.C., District of Columbia, United States
Novartis Investigative Site
Jacksonville, Florida, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Toledo, Ohio, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Houston, Texas, United States
Countries
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Other Identifiers
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CTBM100C2412
Identifier Type: -
Identifier Source: org_study_id
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