Status:
COMPLETED
Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)
Lead Sponsor:
Insmed Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE1
PHASE2
Brief Summary
A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P. aeruginosa increases with age and by a...
Detailed Description
Cystic fibrosis is a genetic disease resulting from mutations in a 230 kb gene on chromosome 7 known as the cystic fibrosis transmembrane conductance regulator (CFTR). Study subjects with CF manifest ...
Eligibility Criteria
Inclusion
- Written informed consent obtained from patient or designated legal guardian prior to the performance of any study related procedures.
- Male or female study subjects ≥6 years of age or older
- Confirmed diagnosis of CF
- History of chronic infection with P. aeruginosa
- Study subjects must produce a screening specimen that is positive for growth of P. aeruginosa
- FEV1 ≥ 40% predicted at Screening
- SaO2 ≥ 90% at Screening while breathing room air
- Ability to comply with study medication use, study visits and study procedures as judged by the investigator
- Ability to produce sputum or be willing to undergo an induction to produce sputum for clinical evaluation
- Clinically stable with no evidence of acute upper or lower respiratory tract infection of history of pulmonary exacerbation within 4 weeks prior to screening
- Key
Exclusion
- Administration of any investigational drug within 8 weeks prior to Screening
- Emergency room visit or hospitalization for CF or respiratory-related illness within 4 weeks prior to screening
- History of alcohol, medication or illicit drug abuse within the 1 year prior to screening
- History of lung transplant
- Female of childbearing potential who is lactating or is not practicing an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD)
- Positive pregnancy test
- Use of any anti-pseudomonal anitbiotics (IV antibiotics, all inhalation antibiotics, oral fluoroquinolones)within the 28 days prior to screening
- Initiation of chronic therapy (i.e. TOBI®, high-dose ibuprofen, rhDNase, macrolide antibiotics) within 28 days prior to screening
- History of sputum or throat swab culture yielding Burkholderia cepacia within 2 years of Screening
- History of mycobacterial or Aspergillus infection
- Requiring treatment within 2 years prior to screening, and/or history of allergic bronchopulmonary aspergillosis.
- History of biliary cirrhosis with portal hypertension, or splenomegaly
- History of daily, continuous oxygen supplementation or requirement for more than 2 L/min at night Change in chest x-ray at screening (or within the 3 months prior to screening)
Key Trial Info
Start Date :
February 22 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00777296
Start Date
February 22 2007
End Date
February 27 2008
Last Update
July 30 2020
Active Locations (11)
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1
Leuven, Belgium
2
Budapest, Hungary
3
Kaposvár, Hungary
4
Skopje, North Macedonia