Elite study.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR377
• Date of registration: 12/09/2005
• Primary sponsor: Chiron corporated ltd
• Public title: Elite study.
• Scientific title: The microbiological efficacy and safety of two treatment regimens of inhaled tobramycine nebuliser solution (TNS) for the treatment of early onset pseudomonas aeruginosa lower respiratory tract infection in subjects with cystic fibrosis. - ELITE
• Date of first enrolment: 1/10/2003
• Target sample size: 120
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=377
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Not applicable; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: H.A.W.M. Tiddens

• Name: H.A.W.M. Tiddens

Key inclusion & exclusion criteria

Inclusion criteria: 1. Male or female subject > 6 months;

2. Diagnosis of CF;

3. First or early lower resp. tract infection with P aeruginosa.
Exclusion criteria: 1. History of aminoglycoside hypersensitivity
symptoms of acute pulmonary disease
invest. drugs within 30 days prior to enrollment;

2. Abnormal result from audiology testing.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Cystic Fibrosis (CF), Pseudomonas infection

Intervention(s)

- 5x blood sample

- 11x lungfunction testing

- 11x swabculture

- 4x audiology testing

Primary Outcome(s)

The primary objective of this study is to estimate the duration of eradication of any strain of P aeruginosa infection during the 27 month study period following TNS treatment of early infection in cystic fibrosis patients.

Secondary Outcome(s)

1. To estimate the proportion of subjects free form P aeruginosa at visit 5 with 300 mg twice daily for either 28 days or 56 days
to assess the safety of patients in the two treatment arms;

2. To assess the proportion of patients requiring hospitalisation for pulmonary exacerbation.

Secondary ID(s)

ISRCTN80955954

N/A

Source(s) of Monetary Support

Chiron corporated ltd