Other Clinical Trial - Randomized, Controlled Study of CF Patients Between

Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years — EARLY

Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Cystic Fibrosis
Fibrosis
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients

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	NCT01082367
Study type	Interventional
Source	Novartis
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	April 2010
Completion date	July 2015

Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years — EARLY

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms