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Completed Phase 1Phase 2 Interventional Results available

Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

ClinicalTrials.gov ID: NCT00558844

Public ClinicalTrials.gov record NCT00558844. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 11:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 1b/2a Multidose Safety and Tolerability Study of Liposomal Amikacin for Inhalation (Arikayce™) in Cystic Fibrosis Patient With Chronic Infections Due to Pseudomonas Aeruginosa.

Study identification

NCT ID
NCT00558844
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Insmed Incorporated
Industry
Enrollment
41 participants

Conditions and interventions

Interventions

  • Arikayce™ 560 mg Drug
  • Placebo for 560 mg Drug
  • Arikayce™ 70 mg Drug
  • Arikayce™ 140 mg Drug
  • Placebo for 70 mg / 140 mg Drug

Drug

Eligibility (public fields only)

Age range
6 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2007
Primary completion
May 31, 2009
Completion
May 31, 2009
Last update posted
Jun 3, 2019

2008 – 2009

United States locations

U.S. sites
19
U.S. states
17
U.S. cities
19
Facility City State ZIP Site status
Not listed Birmingham Alabama
Not listed Los Angeles California
Not listed Miami Florida
Not listed Orlando Florida
Not listed Indianapolis Indiana
Not listed Iowa City Iowa
Not listed Baltimore Maryland
Not listed Boston Massachusetts
Not listed Ann Arbor Michigan
Not listed Minneapolis Minnesota
Not listed Jackson Mississippi
Not listed St Louis Missouri
Not listed Morristown New Jersey
Not listed New Brunswick New Jersey
Not listed Albuquerque New Mexico
Not listed Rochester New York
Not listed Philadelphia Pennsylvania
Not listed Sioux Falls South Dakota
Not listed Seattle Washington

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00558844, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 3, 2019 · Synced Jul 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00558844 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →