Long term study of Arikace in people with CF with Chronic Pseudomonas Aeruginosa Lung Infection
Study Type:
Interventional
Intervention Category:
Anti-Infective
Study Sponsor:
Insmed
Study Phase:
3
Recruitment Status:
Not Yet Recruiting
Study Drug(s):
Arikace
Number of Participants Being Recruited:
500
Single / Multi-Center:
Multi-Center
STUDY BACKGROUND INFORMATION:
The total study period will be up to 96 weeks (approximately 2 years). It will be done as two consecutive extension periods, each consisting of 48 weeks (approximately 12 months). Eligible participants will be re-consented before participating in the second extension period at the completion of the first extension period. Arikace will be taken on a cyclic basis (28 days on and 28 days off) and seen at different time periods in clinic.
ELIGIBILITY
Age:
>= 6 Years
FEV1:
>= 25 Percent Predicted
P. aeruginosa status:
Positive
B. cepacia status:
Not applicable
Other Primary Eligibility Requirements:
To participate in this open-label extension study a subject must have completed either of the other 2 phase 3 studies of Arikace (TR02-108 or TR02-109).
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
