Comparison of efficacy, tolerability and safety of tobramycin inhalation powder using Orbital™ dry powder inhaler (DPI) device vs TOBI Podhaler for lung infections in cystic fibrosis (CF) patients (Tobra Orbital TOBI Trial-TOTT).

Not Applicable

• Conditions: Cystic Fibrosis; Respiratory - Other respiratory disorders / diseases; Human Genetics and Inherited Disorders - Cystic fibrosis; Infection - Other infectious diseases

• Registration Number: ACTRN12620001354976
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-15
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Inclusion criteria, which must be met at the time of study screening, are:
A stable history of chronic CF disease with a FEV1 of greater than or equal to 30% predicted.
Clinical stability, as determined by the clinician’s evaluation, with no pulmonary exacerbation in the past month determined by the patient’s records (e.g. need for IV antibiotics).
Proven previous tolerability to TobiPodhaler.
Chronic Pseudomonas aeruginosa infection as determined by the patient’s records.
Aged equal to or greater than 18 years

Exclusion Criteria

Exclusion criteria are:
•CF patients with severe unstable conditions.
•CF patients with chronic Mycobacterium abscessus and Burkholderia cepacia complex (B. cepacia) colonisation.
•CF patients who are on continuous tobramycin therapy (not on alternate month tobramycin therapy)
•Pregnant or lactating females or females who intend to fall pregnant within the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified