Completed

A Prospective Observational Study in Cystic Fibrosis Patients With Chronic Respiratory Pseudomonas Aeruginosa Infection Treated With TOBI® PODHALER® (Tobramycin Inhalation Powder) or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Over 6 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2015
See protocol details

Summary

Principal SponsorMylan Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 5, 2015

Actual date on which the first participant was enrolled.

This study will include CF patients chronically colonized with P. aeruginosa enrolled in the Cystic Fibrosis Foundation (CFF) PortCF registry and using TOBI® PODHALER® or another FDA-approved inhaled antipseudomonal antibiotic. No therapeutic intervention will be assigned and physicians will use their discretion in choosing a treatment regimen for their patients. Sputum samples (primarily collected during routine clinical follow-up) from patients able to spontaneously produce sputum will be sent to a central laboratory for analysis. In addition, this study will include two optional sub-studies for qualifying patients in the first study year - Sputum microbiology sub-study and TOBI® PODHALER® sputum pharmacokinetics (PK) sub-study.

Official TitleA Prospective Observational Study in Cystic Fibrosis Patients With Chronic Respiratory Pseudomonas Aeruginosa Infection Treated With TOBI® PODHALER® (Tobramycin Inhalation Powder) or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs
NCT02449031
Principal SponsorMylan Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

409 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 6 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate
≥ 6 years of age.
Documented FEV1 ≥ 25% predicted in the previous year.
Diagnosis of cystic fibrosis.
Established diagnosis of chronic P. aeruginosa infection of the lungs defined as two or more positive P. aeruginosa cultures in the previous year as documented in the subject's medical history (this may include a history of one positive culture in the year prior to enrollment and one positive culture from the specimen collected at the baseline visit).
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5 exclusion criteria prevent from participating
Documented FEV1 < 25% predicted in the previous year.
Treatment with compounded tobramycin (e.g. the use of tobramycin IV solution adapted for use by inhalation).
Treatment with inhaled antipseudomonal antibacterial drug(s) that are not FDA approved.
Current participation in an interventional clinical study with an inhaled antibiotic treatment.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 47 locations

Suspended

Novartis Investigative Site

Anchorage, United StatesOpen Novartis Investigative Site in Google Maps
Suspended

Novartis Investigative Site

Little Rock, United States
Suspended

Novartis Investigative Site

Bellflower, United States
Suspended

Novartis Investigative Site

Fullerton, United States
Completed47 Study Centers