Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
1 other identifier
interventional
302
17 countries
61
Brief Summary
A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients. The purpose of this study is to determine whether Arikayce™ is effective in treating chronic lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2012
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2011
CompletedFirst Posted
Study publicly available on registry
March 15, 2011
CompletedStudy Start
First participant enrolled
February 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2013
CompletedResults Posted
Study results publicly available
June 24, 2019
CompletedJune 16, 2020
May 1, 2020
1.3 years
March 14, 2011
April 3, 2019
May 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)
Relative Change (%) from baseline to end of study (Day 168) in FEV1 (1 second)
Baseline to168 days
Secondary Outcomes (6)
Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)
Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168.
Number of Participants Experiencing a Pulmonary Exacerbation
168 days
Number of Participants to First Antipseudomonal Antibiotic Treatment for Pulmonary Exacerbation
168 days
Number of Participants to First All Cause Hospitalization
168 days
Change in Density (Log CFU) in Pseudomonas Aeruginosa in Sputum
Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168
- +1 more secondary outcomes
Study Arms (2)
Arikayce™
EXPERIMENTALArikayce™ is liposomal amikacin for inhalation
TOBI®
ACTIVE COMPARATORTOBI® is tobramycin inhalation solution
Interventions
Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization. * 590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer. * Administration time is approximately 13 minutes. * liposomal amikacin for inhalation will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment.
300 mg tobramycin inhalation solution is administered twice a day using a PARI LC® Plus nebulizer. * Nebulization time is approximately 20 minutes for each administration. * Tobramycin inhalation solution will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment
Eligibility Criteria
You may qualify if:
- Written informed consent or assent
- Confirmed diagnosis of CF
- History of chronic infection with Pseudomonas aeruginosa
- Sputum culture positive for Pseudomonas aeruginosa at Screening
- FEV1 ≥ 25% of predicted value at Screening
You may not qualify if:
- FEV1 \<25% of predicted at Screening
- History of major complications of lung disease within 8 weeks prior to Screening
- Hemoptysis of ≥60 mL in a 24-hour period within 4 weeks prior to Screening
- History of positive culture for Burkholderia cepacia within 2 years prior to Screening
- History of pulmonary tuberculosis or non-tuberculous mycobacterial lung disease treated within 2 years prior to Screening or requiring treatment at the time of screening
- History of Allergic Broncho-Pulmonary Aspergillosis or any other condition requiring systemic steroids at a dose ≥ equivalent of 10 mg/day of prednisone within 3 months prior to Screening
- Presence of any clinically significant cardiac disease
- History of lung transplantation
- Daily, continuous oxygen supplementation or nighttime supplemental oxygen requirement of greater than 2 L/min
- Administration of any investigational products within 8 weeks prior to study Day 1
- Smoking tobacco or any substance within 6 months prior to screening or anticipated inability to refrain from smoking throughout the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
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Vienna, Austria
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Hamilton, Ontario, Canada
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Halifax, Canada
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Vancouver, Canada
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Copenhagen, Denmark
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Bron, France
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Lille, France
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Montpellier, France
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Nancy, France
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Paris, France
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Pierre-Bénite, France
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Rouen, France
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Berlin, Germany
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Essen, Germany
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Hamburg, Germany
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Hanover, Germany
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Kiel, Germany
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München, Germany
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Athens, Greece
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Marousi, Greece
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Budapest, Hungary
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Debrecen, Hungary
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Szeged, Hungary
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Dublin, Ireland
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Ancona, Italy
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Brescia, Italy
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Catania, Italy
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Genova, Italy
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Milan, Italy
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Parma, Italy
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Roma, Italy
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Verona, Italy
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Utrecht, Netherlands
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Gdansk, Poland
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Lodz, Poland
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Lublin, Poland
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Poznan, Poland
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Rabka-Zdrój, Poland
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Rzeszów, Poland
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Warsaw, Poland
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New Belgrade, Serbia
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Banská Bystrica, Slovakia
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Bratislava, Slovakia
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Košice, Slovakia
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Barcelona, Spain
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Madrid, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Birmingham, United Kingdom
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Glasgow, United Kingdom
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Leeds, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom
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Penarth, United Kingdom
Related Publications (1)
Bilton D, Pressler T, Fajac I, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Sole A, Quittner AL, Liu K, McGinnis JP 2nd, Eagle G, Gupta R, Konstan MW; CLEAR-108 Study Group. Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis. J Cyst Fibros. 2020 Mar;19(2):284-291. doi: 10.1016/j.jcf.2019.08.001. Epub 2019 Aug 23.
PMID: 31451351DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kevin Mange (Senior VP, Clinical Development and Medical Affairs)
- Organization
- Insmed Incorporated
Study Officials
- STUDY DIRECTOR
Gina Eagle, MD
Insmed Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2011
First Posted
March 15, 2011
Study Start
February 29, 2012
Primary Completion
June 1, 2013
Study Completion
September 18, 2013
Last Updated
June 16, 2020
Results First Posted
June 24, 2019
Record last verified: 2020-05