MedDataX Logo

Ext. Long-term Safety Study in CF Patients: Single Arm TIP

NCT ID: NCT01775137

Last Updated: 2015-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01519661

Pulmonary Infections Pseudomonas Aeruginosa in Cystic Fibrosis
COMPLETED PHASE4

Second Open Label Extension to Bridging Study CTBM100C2303

NCT01069705

Pulmonary Infections Pseudomonas Aeruginosa
COMPLETED PHASE3

Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis

NCT00388505

Cystic Fibrosis
COMPLETED PHASE3

Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

NCT00125346

Cystic Fibrosis
TERMINATED PHASE3

Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis

NCT00004829

Cystic Fibrosis Bacterial Infection
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Long-term Safety of TIP

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TBM100

TIP 112 mg/b.i.d

Group Type EXPERIMENTAL

TBM100

Intervention Type DRUG

Tobramycin inhalation powder (TIP) 112mg/b.i.d

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TBM100

Tobramycin inhalation powder (TIP) 112mg/b.i.d

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Completion of the core study CTBM100C2401 and able to comply with all protocol requirements of the extension study

Exclusion Criteria

* Serum creatinine 2mg/dl, BUN 40mg/dl or proteinuria 2+ or more at the time of entry into the extension
* Use of loop diuretics within 7 days prior to entry into the extension study
* Pregnant or nursing women
* Women of child bearing potential unless using highly effective method of contraception as indicated in the protoco
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Akron, Ohio, United States

Site Status

Novartis Investigative Site

Charleston, South Carolina, United States

Site Status

Novartis Investigative Site

Dallas, Texas, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Capital Federal, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Site Status

Novartis Investigative Site

New Lambton Heights, New South Wales, Australia

Site Status

Novartis Investigative Site

Parkville, Victoria, Australia

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Florence, FI, Italy

Site Status

Novartis Investigative Site

Palermo, Italy, Italy

Site Status

Novartis Investigative Site

Messina, ME, Italy

Site Status

Novartis Investigative Site

Verona, VR, Italy

Site Status

Novartis Investigative Site

Roma, , Italy

Site Status

Novartis Investigative Site

Mexico City, Mexico City, Mexico

Site Status

Novartis Investigative Site

Monterrey, Nuevo León, Mexico

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Valencia, Valencia, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Canada Germany Hungary Italy Mexico Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTBM100C2401E1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles
NCT02015663 TERMINATED PHASE4
A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
NCT01111383 COMPLETED PHASE3
Safety, Tolerability and Pharmacokinetics of Tiotropium in Cystic Fibrosis Patients
NCT02172534 COMPLETED PHASE1
Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)
NCT01844778 COMPLETED PHASE4
Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)
NCT02677701 COMPLETED PHASE4
Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients
NCT03341741 COMPLETED PHASE3
Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis
NCT01608555 COMPLETED PHASE4
A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo
NCT00918957 COMPLETED PHASE3
Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection
NCT02712983 COMPLETED PHASE2
A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
NCT00006280 COMPLETED PHASE2
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
NCT01082367 COMPLETED PHASE3
Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa
NCT00757237 COMPLETED PHASE3
Observational Study in Cystic Fibrosis Patients Using TOBI® PODHALER® or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs
NCT02449031 COMPLETED
Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution
NCT02038803 TERMINATED
Amiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis
NCT00547053 COMPLETED PHASE1
Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis
NCT02035488 COMPLETED PHASE1/PHASE2
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
NCT02212587 COMPLETED PHASE1
Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection
NCT00794586 COMPLETED PHASE2
Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study
NCT00420836 COMPLETED PHASE1
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
NCT00737100 COMPLETED PHASE2
OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis
NCT02054156 COMPLETED PHASE3
Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis
NCT01337219 UNKNOWN PHASE1/PHASE2
Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin
NCT00634192 COMPLETED PHASE3
Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
NCT01695343 COMPLETED PHASE2
Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF
NCT01641822 COMPLETED PHASE3