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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00388505

Purpose

This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

Condition	Intervention	Phase
Cystic Fibrosis	Drug: Tobramycin Inhalation Powder Drug: Tobramycin Solution	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Tobramycin Tobramycin sulfate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety assessed by incidence of treatment-emergent adverse events and clinical laboratory results [ Time Frame: AEs - weeks 1, 2, 3, 5, 7, 9, 13, 17, 21 and 25. Safety labs - weeks -4, 1, 5, 9, 13, 17, 21 and 25. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Serum tobramycin concentrations
Audiology test results (at select CF centers)
Change in forced expiratory volume in one second (FEV1) at baseline and after Week 24
Patient satisfaction, assessed using the Treatment Satisfaction Questionnaire for Medication

Enrollment:	517
Study Start Date:	February 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: Tobramycin Inhalation Powder
Active Comparator: 2	Drug: Tobramycin Solution

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of cystic fibrosis
Male and female subjects at least 6 years of age at the time of screening.
FEV1 at screening must be at least 25% and less than or equal to 75% of normal predicted values for age, sex, and height based on Knudson criteria.
P aeruginosa, a type of bacteria, must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit.
Able to comply with all protocol requirements.
Clinically stable in the opinion of the investigator.
Use of an effective means of contraception in females of childbearing potential.
Provide written informed consent, HIPAA authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure.

Exclusion Criteria:

History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to screening and/or sputum culture yielding B cepacia at screening.
Coughing up more than 60cc of blood from the respiratory tract at any time within 30 days prior to study drug administration.
Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Females who are pregnant (positive pregnancy test), lactating, or are planning to become pregnant during the study.
History of hearing loss or chronic ringing in the ears deemed clinically significant by the investigator.
Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study drug administration.
Use of loop diuretics within 7 days prior to study drug administration.
Use of any investigational treatment within 28 days prior to study drug administration.
Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or inhaled costicosteroids within 28 days prior to study drug administration (subjects may be taking these therapies at the time of enrollment, but they must have initiated treatment more than 28 days prior to study drug administration).

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388505

Show 72 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Michael Konstan, MD

University Hospitals Case Medical Center

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	external affairs, novartis
ClinicalTrials.gov Identifier:	NCT00388505 History of Changes
Other Study ID Numbers:	CTBM100C2302
Study First Received:	October 16, 2006
Last Updated:	June 23, 2009
Health Authority:	United States: Food and Drug Administration; France: Agence Française de Sécurité Sanitaire des produits de Santé; Germany: Federal Institute for Drugs and Medical Devices; Italy: Agenzia Italiana del Farmaco; Netherlands: College ter beoordeling van geneesmiddelen Medicines Evaluation Board; Spain: Ministerio de Sanidad y Consumo, Agencia Española del Medicamento y Productos Sanitarios; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

tobramycin

Additional relevant MeSH terms:

Respiratory Aspiration
Cystic Fibrosis
Fibrosis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pancreatic Diseases
Digestive System Diseases

Lung Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012