Pseudomonas Aeruginosa InfectionPhase 3NCT01315678
Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
A Phase 3 study testing Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer. and Tobramycin inhalation solution using a PARI LC® Plus nebulizer. in people with Pseudomonas Aeruginosa Infection, run by Insmed Incorporated at 62 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Pseudomonas Aeruginosa Infection
- What is being tested?
- Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer. and Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 62 sitesin 18 countries
- Study dates
- 29 Feb 2012to 18 Sep 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
62 sites in 18 countries.
62 sites in 18 countries
Italy8 sites
Study site
Ancona
Study site
Brescia
Study site
Catania
Study site
Genova
Study site
Milan
Study site
Parma
Study site
Roma
Study site
Verona
France7 sites
Study site
Bron
Study site
Lille
Study site
Montpellier
Study site
Nancy
Study site
Paris
Study site
Pierre-Bénite
Study site
Rouen
Poland7 sites
Study site
Gdansk
Study site
Lodz
Study site
Lublin
Study site
Poznan
Study site
Rabka-Zdrój
Study site
Rzeszów
Study site
Warsaw
United Kingdom7 sites
Study site
Birmingham
Study site
Glasgow
Study site
Leeds
Study site
Liverpool
Study site
London
Study site
Nottingham
Study site
Penarth
Germany6 sites
Study site
Berlin
Study site
Essen
Study site
Hamburg
Study site
Hanover
Study site
Kiel
Study site
München
Bulgaria4 sites
Study site
Pleven
Study site
Plovdiv
Study site
Sofia
Study site
Varna
Canada3 sites
Study site
Halifax
Study site
Hamilton, Ontario
Study site
Vancouver
Slovakia3 sites
Study site
Banská Bystrica
Study site
Bratislava
Study site
Košice
About this study
Official title: 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
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.
Read the detailed description
CF is a genetic disease resulting from mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Patients with CF manifest pathological changes in a variety of organs that express CFTR. The lungs are frequently affected often resulting in chronic infections by bacteria such as Pseudomonas aeruginosa and airway inflammation. Treatment of chronic lung infections is one of the principal goals of CF therapy. Arikayce™ LAI (liposomal amikacin for inhalation) is a sustained-release formulation of amikacin encapsulated inside nanoscale liposomal carriers designed for administration via inhalation. It is hypothesized that the sustained-release pulmonary targeting and biofilm penetration properties of this formulation will have several advantages over current therapies in treating CF patients with chronic lung infection caused by Pseudomonas aeruginosa.
This Phase 3 study has been designed to evaluate the efficacy, safety and tolerability of Arikayce™ in treating CF patients with chronic bronchopulmonary infection compared to a currently available antibiotic, TOBI® Inhalation Solution. Eligible participants will be randomized 1:1 to receive 590 mg of Arikayce™ once daily via a PARI Investigational eFlow® Nebulizer or 300 mg TOBI® BID via a PARI LC® PLUS nebulizer. Participants will receive 3 cycles of treatment with each cycle being comprised of 28 days on treatment followed by 28 days off-treatment. Total study duration is up to 186 days (~6 months) including an up to 18 day Screening period. Participants will be evaluated for safety, tolerability and efficacy bi-weekly during the first 4 weeks of treatment, and thereafter every 4 weeks for the duration of the study. Pharmacokinetics (PK) of Arikayce™ in blood, sputum and 24-hour urine will be determined in a subgroup of study participants who consent to PK evaluation.
At the completion of the TR02-108 protocol, participants who have consented and meet study safety criteria may enroll in the long-term, open-label, multi-cycle extension study of 590 mg of Arikayce™ (under a separate protocol TR02-110). Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other studies evaluating amikacin liposome inhalation suspension.
- Conditions
- Pseudomonas Aeruginosa Infection
- Being tested
- Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
- Keywords
- Cystic Fibrosis, Respiratory Infections, Pulmonary Cystic Fibrosis, CFTR, Amikacin, Anti-bacterial Agents, Amikacin liposome inhalation suspension (ALIS)
- Medical subject headings
- Pseudomonas Infections, Cystic Fibrosis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.Drug
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.
Tobramycin inhalation solution using a PARI LC® Plus nebulizer.Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Arikayce™ | Experimental | Arikayce™ is liposomal amikacin for inhalation Receives: Drug: Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer. |
| TOBI® | Active comparator | TOBI® is tobramycin inhalation solution Receives: Drug: Tobramycin inhalation solution using a PARI LC® Plus nebulizer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)
Relative Change (%) from baseline to end of study (Day 168) in FEV1 (1 second)
Measured: Baseline to168 days
Secondary outcomes (6)
Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)
Relative changes (%) from baseline to Study Days 14, 28, 57, 84, 113, 140, 168 in FEV1
Measured: Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168.
Number of Participants Experiencing a Pulmonary Exacerbation
Number of participants experiencing a pulmonary exacerbation measured by number with event and number censored
Measured: 168 days
Number of Participants to First Antipseudomonal Antibiotic Treatment for Pulmonary Exacerbation
Number of participants to first antipseudomonal antibiotic treatment for pulmonary exacerbation measured by number with event and number censored
Measured: 168 days
Number of Participants to First All Cause Hospitalization
Number of participants to first all cause hospitalization measured by number with event and number censored
Measured: 168 days
Change in Density (Log CFU) in Pseudomonas Aeruginosa in Sputum
Change in density (Log CFU) from baseline in Pseudomonas aeruginosa in sputum
Measured: Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168
Relative Percent (%) Change in Respiratory Symptoms as Measured by the CFQ-R
Quality of Life was measured by the absolute change from baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory scale. Disease specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms in patients with a diagnosis of cystic fibrosis. Scores range from 0 to 100, with higher scores indicating better health. Scores for each Health Related Quality of Life (HRQoL) domain; after recoding, each item is summed to generate a domain score and standardized.
Measured: Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study start29 Feb 2012
- Primary completionJun 2013
- Study completion18 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pseudomonas Aeruginosa InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gina Eagle, MD, Study director, Insmed Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315678
- Sponsor's protocol ID
- TR02-108
- Status last verified
- May 2020
- First submitted
- 14 Mar 2011
- Last updated
- 16 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 31451351
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01315678
- Acronym / sponsor ID
- TR02-108
- Conditions
- Pseudomonas Aeruginosa Infection
- Keywords
- Cystic Fibrosis, Respiratory Infections, Pulmonary Cystic Fibrosis, CFTR, Amikacin, Anti-bacterial Agents, Amikacin liposome inhalation suspension (ALIS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2012 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- 18 Sep 2013 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Posted 24 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CF is a genetic disease resulting from mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Patients with CF manifest pathological changes in a variety of organs that express CFTR. The lungs are frequently affected often resulting in chronic infections by bacteria such as Pseudomonas aeruginosa and airway inflammation. Treatment of chronic lung infections is one of the principal goals of CF therapy. Arikayce™ LAI (liposomal amikacin for inhalation) is a sustained-release formulation of amikacin encapsulated inside nanoscale liposomal carriers designed for administration via inhalation. It is hypothesized that the sustained-release pulmonary targeting and biofilm penetration properties of this formulation will have several advantages over current therapies in treating CF patients with chronic lung infection caused by Pseudomonas aeruginosa.
This Phase 3 study has been designed to evaluate the efficacy, safety and tolerability of Arikayce™ in treating CF patients with chronic bronchopulmonary infection compared to a currently available antibiotic, TOBI® Inhalation Solution. Eligible participants will be randomized 1:1 to receive 590 mg of Arikayce™ once daily via a PARI Investigational eFlow® Nebulizer or 300 mg TOBI® BID via a PARI LC® PLUS nebulizer. Participants will receive 3 cycles of treatment with each cycle being comprised of 28 days on treatment followed by 28 days off-treatment. Total study duration is up to 186 days (~6 months) including an up to 18 day Screening period. Participants will be evaluated for safety, tolerability and efficacy bi-weekly during the first 4 weeks of treatment, and thereafter every 4 weeks for the duration of the study. Pharmacokinetics (PK) of Arikayce™ in blood, sputum and 24-hour urine will be determined in a subgroup of study participants who consent to PK evaluation.
At the completion of the TR02-108 protocol, participants who have consented and meet study safety criteria may enroll in the long-term, open-label, multi-cycle extension study of 590 mg of Arikayce™ (under a separate protocol TR02-110). Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other studies evaluating amikacin liposome inhalation suspension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arikayce™ | Experimental | Drug: Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.Arikayce™ is liposomal amikacin for inhalation |
| TOBI® | Active comparator | Drug: Tobramycin inhalation solution using a PARI LC® Plus nebulizer.TOBI® is tobramycin inhalation solution |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.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. | Drug | Arikayce™ |
| Tobramycin inhalation solution using a PARI LC® Plus nebulizer.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 | Drug | TOBI® |
Primary outcome
Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline to168 days
Relative Change (%) from baseline to end of study (Day 168) in FEV1 (1 second)
6 secondary outcomes
Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168.
Number of Participants Experiencing a Pulmonary Exacerbation
Time frame: 168 days
Number of Participants to First Antipseudomonal Antibiotic Treatment for Pulmonary Exacerbation
Time frame: 168 days
Number of Participants to First All Cause Hospitalization
Time frame: 168 days
Change in Density (Log CFU) in Pseudomonas Aeruginosa in Sputum
Time frame: Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168
Relative Percent (%) Change in Respiratory Symptoms as Measured by the CFQ-R
Time frame: Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31451351Bilton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Eagle, MD study director
Insmed Incorporated
62 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer. and Tobramycin inhalation solution using a PARI LC® Plus nebulizer. in people with Pseudomonas Aeruginosa Infection, run by Insmed Incorporated at 62 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Italy, France, Poland, United Kingdom, Germany and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) (time frame: Baseline to168 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01315678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020; AzTrials last refreshed its copy on 26 Oct 2026.