Study Description
Screening
Study Centers
Contact/Consent
Cystic Fibrosis
Cystic fibrosis (CF) is an inherited disease of the mucus and sweat glands, and mostly affects the lungs, pancreas, liver, intestines, sinuses, and sex organs. [Source: www.nhlbi.nih.gov]
Novartis is seeking people to participate in a clinical trial(s) testing the safety
and effectiveness of Novartis products. Novartis recommends that you consult your
doctor before participating in a clinical trial.
How to use this system:
The purpose of this system is to help connect interested study participants with clinical
research centers. The following is a brief outline explaining the main steps involved in
using this system. Please note that every step in this process is optional.
1. Select a clinical trial that you feel best suits your (or the participant's)
health condition.
2. Answer the screening questions to see if you (or the participant) meet
the preliminary qualifications for
the study. The answers to these questions
are not retained by this system.
3. Select a study center to contact for additional information about the
clinical trial.
4. Set up an account and agree to the terms of use for this system.
5. Submit your information to the study center you selected.
6. The study center may contact you and may ask more questions about your
(or the participant's) eligibility
for the study. The study center may invite you
(and the participant if applicable) to travel to the study center
for additional screening tests. Novartis cannot guarantee that you
will be contacted by the study center.
7. If you are eligible to participate in the study, then you will be required
to sign an
informed consent before enrolling in the study. An informed consent
is provided to you to help you understand the clinical trial, the nature of
the medical treatment (if any),
procedures and known risks involved, before you agree to participate in the study.
For more information about clinical trial participation, click here. Also, for additional information
about how Novartis helps to protect the privacy of the personal information that you provide to us, please
see the Novartis Privacy Policy.
Please review the details of the clinical trial(s) listed below and click on the one that you feel best suits
your (or the participant's) condition.
Cystic Fibrosis Study CTBM100C2302
Novartis Pharmaceuticals Corporation and Chiron Corporation are conducting a clinical research study to compare the safety and effectiveness of an investigational formulation, Tobramycin Inhalation Powder (TIP), compared to Tobramycin Inhalation Solution (TOBI®) for participants 6 years of age and older, that have Cystic Fibrosis and a lung infection caused by the bacteria Pseudomonas aeruginosa. The purpose of this clinical research study is to study how breathing in TIP twice a day compares to breathing in TOBI®. Tobramycin Inhalation Powder (TIP) is an “investigational formulation”, which means that it is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). TOBI® is a drug that has been approved for sale in the United States by the U.S. Food and Drug Administration (FDA) for the treatment of Pseudomonas aeruginosa infections in Cystic Fibrosis patients.
Trial phase: Phase 3
Participation Duration: Participants will be required visit the study center approximately 12 times over a 25 week period.
Protocol Number: CTBM100C2302
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