Ease of use of TIP compared to TIS and colistimethate in P. aeruginosa
Research type
Research Study
Full title
An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistemethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis
IRAS ID
124775
Contact name
Beatrice Grimalt
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2012-001565-33
Duration of Study in the UK
1 years, 1 months, 6 days
Research summary
Cystic fibrosis (CF) patients are susceptible to respiratory infection with Pseudomonas aeruginosa, which is associated with decline in lung function and increased morbidity and mortality.
Tobramycin inhalation solution (TIS) has been established as an effective and safe inhaled antibiotic for the treatment of chronic P. aeruginosa infection in CF patients. Colistimethate has also been used widely as an inhaled drug for P. aeruginosa infections in CF patients. Administration of nebulized TIS and colistimethate is complex and time consuming, placing a high burden on CF patients and creating an obstacle to treatment adherence. Tobramycin inhalation powder (TIP) is designed to provide the same level of efficacy and safety as TIS but with a substantially simplified method of administration. TIP is supplied in hard capsules to be inhaled via T-362 Dry Powder Inhaler also known as the TOBI Podhaler. TOBI Podhaler is registered for the suppressive therapy of chronic pulmonary infection due to P. aeruginosa in adults and children aged 6 years and older with CF.
The purpose of this Phase IV study is to explore the ease of use and prevalence of microbial contamination of the TOBI Podhaler (TIP) compared with tobramycin inhalation solution (TIS) and colistimethate administered via nebulizer in the treatment of CF patients chronically infected with P. aeruginosa.
This is an open label, non-randomised, study in patients age 6 years or older with impaired lung function (FEV1 of at >25% and <= 90% predicted normal). The study will consist of a screening visit, treatment cycle 1 (28 days on treatment with the patient's usual antibiotic - colistimethate, TIS or TIP followed by 28 days off treatment) and treatment cycle 2 (28 days on treatment with TIP followed by 28 days off treatment). Patients will attend 6 clinic visits during the study.
30 patients are expected to be recruited into this study in the UK across 6-7 centres. The duration of the study will be approximately 17 months from first patient entering the study to the last patient completing.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
13/SC/0268
Date of REC Opinion
21 Jun 2013
REC opinion
Further Information Favourable Opinion