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Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02178540
Recruitment Status : Completed
First Posted : June 30, 2014
Results First Posted : May 23, 2016
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Placebo Device: Tobi Podhaler Phase 4

Detailed Description:

The objective of the HF study is to determine whether cystic fibrosis patients in the US, representative of potential TOBI Podhaler users, can understand and follow the approved IFU and the extent to which the approved IFU supports safe and effective use of the Podhaler device.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules
Study Start Date : August 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Open label
one dose (4 capsules) of placebo
Drug: Placebo
one dose (4 capsules) of placebo

Device: 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




Primary Outcome Measures :
  1. 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 [ Time Frame: 1 Day ]
    Recording all use errors and close calls associated with inhalation of one dose of TOBI Podhaler (i.e., inhaling the contents of four placebo capsules via the Podhaler device) by subjects (CF patients, and caregivers, if applicable). The study population consisted of CF patients (and caregivers) naïve to the Podhaler device and untrained in the use of the device. Assessing the root cause of use errors and close calls for 6 defined critical errors (agreed with the FDA) and establishing those which can be attributed to a lack of clarity or presence of ambiguities in the IFU content, i.e., errors attributable to a failure to understand the IFU.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178540


Locations
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United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85016
United States, California
Novartis Investigative Site
Long Beach, California, United States, 90806
Novartis Investigative Site
Los Angeles, California, United States, 90027
Novartis Investigative Site
Ventura, California, United States, 93003
United States, District of Columbia
Novartis Investigative Site
Washington, District of Columbia, United States, 20010-2120
United States, Florida
Novartis Investigative Site
Jacksonville, Florida, United States, 32207
United States, Illinois
Novartis Investigative Site
Chicago, Illinois, United States, 60611
United States, New York
Novartis Investigative Site
New York, New York, United States, 10595
United States, Ohio
Novartis Investigative Site
Toledo, Ohio, United States, 43606
United States, Oklahoma
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73104
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Novartis Investigative Site
Portland, Oregon, United States, 97239
United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02178540    
Other Study ID Numbers: CTBM100C2412
First Posted: June 30, 2014    Key Record Dates
Results First Posted: May 23, 2016
Last Update Posted: May 23, 2016
Last Verified: April 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Human factors, TOBI® Podhaler™, Instructions For use, IFU, CF patients
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents