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Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.

NCT00775138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-07-10

Study results available
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Summary

This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.

Conditions

Interventions

DRUG

280 mg Arikayce™

Study subjects will receive Arikace™ 280 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.

DRUG

Matching Placebo for Cohort 1

Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.

DRUG

560 mg Arikayce™

Study subjects will receive Arikace™ 560 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.

DRUG

Matching Placebo for Cohort 2

Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.

Sponsors & Collaborators

Principal Investigators

  • Gina Eagle, MD · Insmed Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-24
Primary Completion
2009-05-11
Completion
2009-05-11

Countries

  • United States
  • Bulgaria
  • Greece
  • Hungary
  • India
  • Poland
  • Serbia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00775138 on ClinicalTrials.gov