cystic fibrosis MedDRA version: 19.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: TOBI Podhaler
Pharmaceutical Form: Inhalation powder, hard capsule
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation us
Sponsors
Novartis Pharmaceuticals Corporation
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether CF patients, representative of potential TOBI® Podhaler™ users, could understand and follow the approved IFU and the extent to which the approved IFU supports safe and effective use of the Podhaler device.;Secondary Objective: Not applicable;Primary end point(s): Safe and effective use of the podhaler device by CF patients The primary variables of this study include: - Completion status of placebo capsule use (pass/fail) - Existence of a correlation between IFU and placebo capsule use completion status (yes/no);Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed