A randomized, open label, multicentre, phase 3 trial to assess the safety of Tobramycin Inhalation Powder compared to TOBI in cystic fibrosis subjects - TIP003

CHIRON CORPORATION LIMITED0 sites500 target enrollmentJune 23, 2006

ConditionsCystic Fibrosis with presence of Pseudomonas aeruginosa infection MedDRA version: 6.1Level: PTClassification code 10011763

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cystic Fibrosis with presence of Pseudomonas aeruginosa infection
Sponsor: CHIRON CORPORATION LIMITED
Enrollment: 500
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 23, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

CHIRON CORPORATION LIMITED

Eligibility Criteria

Inclusion Criteria

•Confirmed diagnosis of cystic fibrosis by sweat test with 60 mEq/L or higher chlorine content, by documented quantitative pilocarpine iontophoresis QPIT or by homozygosis for 61508;F508 genetic mutation or by heterozygosis for two well\-characterized mutations and two clinical findings coherent with CF diagnosis. Subjects of both sexes aged 61619; 6 years at moment of screening. FEV1 at screening must be 61619; 25 and 61603; 75 compared with value normally predicted for age, sex and height, based on Knudson criteria. P. aeruginosa must be present in culture grown on sputum/pharyngeal swab or bronchoalveolar lavage BAL during the six months prior to screening and in culture grown on sputum/pharyngeal swab at screening visit. Subjects capable of adhering to protocol requirements. Clinically stable in researcher s opinion. Use of an effective contraceptive method for women potentially able to bear children. Written informed consent, HIPAA authorization where applicable and agreement as appropriate before any procedure connected with trial is carried out.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•History of culture grown on sputum/pharyngeal swab or BAL that showed Burkholderia cepacia B cepacia within the 2 years prior to screening and/or culture grown on sputum that shows B cepacia at screening. Haemoptysis greater than 60 cc at any moment during the 30 days prior administration of the drug under investigation. Known local or systemic hypersensitivity to aminoglycosides or antibiotics by inhalation. Serum creatinine 2 mg/dl or higher, BUN 40 mg/dl or higher, or altered urine test defined as proteinuria 2 or greater. Pregnant women positive pregnancy test , breastfeeding women, and women planning a pregnancy during the trial period. History of hypoakusis or chronic tinnitus considered clinically significant by the researcher. Use of systemic or inhaled anti\-pseudomonas antibiotics during the 28 days prior to administration of the drug under investigation. Use of ansa diuretics during the 7 days prior to administration of the drug under investigation. Use of any therapy under investigation during the 28 days prior to administration of the drug under investigation. Chronic therapy with macrolides started during the 28 days prior to administration of the drug under investigation subjects may take macrolide therapy at the moment of enrolling in TIP003, but have to have started the treatment more than 28 days before administration of the drug under investigation . Treatment with dornase alfa started during the 28 days prior to administration of the drug under investigation subjects may take treatment with dornase alfa at the moment of enrolling in TIP003, but have to have started the treatment more than 28 days before administration of the drug under investigation . Treatment with inhaled steroids or increase in dosage during the 28 days prior to administration of the drug under investigation subjects may take inhaled steroids at the moment of enrolling in TIP003, but have to have started the treatment more than 28 days before administration of the drug under investigation .