Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Cystic Fibrosis
Fibrosis
Pseudomonas Aeruginosa in Cystic Fibrosis
Pulmonary Infections

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01356147` - Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)	Phase 4
	Completed	`NCT01069705` - Second Open Label Extension to Bridging Study CTBM100C2303	Phase 3

See also

Status

Clinical Trial

Phase

Completed

NCT01356147 - Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)

Phase 4

Completed

NCT01069705 - Second Open Label Extension to Bridging Study CTBM100C2303

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT01519661
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 4
Start date	January 2012
Completion date	January 2014

Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms