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

• Conditions: Cystic Fibrosis with presence of Pseudomonas aeruginosa infection; MedDRA version: 6.1Level: PTClassification code 10011763

• Registration Number: EUCTR2005-003772-37-IT
• Lead Sponsor: CHIRON CORPORATION LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-23
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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 .

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified