Cystic FibrosisPhase 3NCT01316276
Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
A Phase 3 study testing Liposomal amikacin for inhalation in people with Cystic Fibrosis, run by Insmed Incorporated at 50 sites in 17 countries.
Trial summary
The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Liposomal amikacin for inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 50 sitesin 17 countries
- Study dates
- 5 Oct 2012to 16 Jul 2015
- 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
- Subject has completed study TR02-108, and has been compliant with the study protocol
- Women of childbearing potential must agree to use reliable methods of contraception for the duration of the study
Who cannot join
- Subject met any of the listed criteria for study drug discontinuation in protocol TR02-108.
- Abnormal laboratory assessments including LFT (≥ 3× upper limit of normal [ULN]), serum creatinine (> 2× ULN) and absolute neutrophil count [ANC] (< 1000).
- Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
- History of alcohol, medication or illicit drug abuse within the 6 months prior to consent.
- Smoking tobacco or any substance within 6 months prior to consent or anticipated inability to refrain from smoking throughout the study
Trial locations and contacts
50 sites in 17 countries.
50 sites in 17 countries
Poland7 sites
Study site
Gdansk
Study site
Lodz
Study site
Lublin
Study site
Poznan
Study site
Rabka-Zdrój
Study site
Rzeszów
Study site
Warsaw
Germany5 sites
Study site
Berlin
Study site
Essen
Study site
Hamburg
Study site
Hanover
Study site
München
Italy5 sites
Study site
Brescia
Study site
Catania
Study site
Parma
Study site
Roma
Study site
Verona
Belgium4 sites
Study site
Antwerp
Study site
Brussels
Study site
Ghent
Study site
Leuven
Bulgaria4 sites
Study site
Pleven
Study site
Plovdiv
Study site
Sofia
Study site
Varna
United Kingdom4 sites
Study site
Leeds
Study site
London
Study site
Nottingham
Study site
Penarth
Slovakia3 sites
Study site
Banská Bystrica
Study site
Bratislava
Study site
Košice
About this study
Official title: Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of LAI were evaluated for up to approximately 2 years.
Read the detailed description
This was a long-term, open-label, multi-cycle extension study for patients in the Phase 3 study TR02-108 and TR02-109 who had successfully completed the 168-day study period and met study safety criteria. As this was a safety and tolerability long-term extension study, no sample size calculations were performed. All patients who completed TR02-108, were compliant with the study protocol, and did not meet any of the criteria listed for study discontinuation (safety reasons or non-compliance) were able to participate in this open-label study.
The end of study visit for TR02-108 was to serve as the baseline study visit (Day 1) for TR02-110 if the patient had signed the informed consent at least 4 days prior to the end of study visit and met all safety criteria for TR02-110. If the end of study visit was not used as the baseline visit, a separate baseline visit (Day 1) was to be performed within 14 days of completing TR02-108.
Patients were to receive a delivered dose of 590 mg LAI QD via a PARI Investigational eFlow® Nebulizer System (eFlow®) for 28 days followed by a 28-day off-treatment period. This cycle (28 days on treatment, 28 days off treatment) was to be repeated for up to 12 cycles. The study was implemented as 2 consecutive extension periods, each consisting of 48 weeks (approximately 12 months). Patients were re-consented for the second extension period at the completion of the first extension period. The total study period was up to 96 weeks (approximately 2 years).
During the first 28 days of treatment, patients were evaluated at the study site bi-weekly for safety, tolerability and efficacy. Thereafter, for the duration of the study, patients were evaluated at the study site on the first and last days of dosing during the on-treatment periods. During the study, starting with the off-treatment period of Cycle 1, patients were contacted by telephone once during every 28-day period to assess safety. A final site visit occurred 28 days after last dose of LAI. 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
- Cystic Fibrosis
- Being tested
- Liposomal amikacin for inhalation
- Keywords
- Cystic Fibrosis, Respiratory Infections, Pulmonary Cystic Fibrosis, cystic fibrosis transmembrane conductance regulator (CFTR), Anti-bacterial Agent, Arikayce, ALIS, LAI
- Medical subject headings
- 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 inhalationDrug
- 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 in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment.
| Study group | Role | What they receive |
|---|---|---|
| LAI | Experimental | 590 mg LAI QD via a PARI Investigational eFlow® Nebulizer System (eFlow®) for 28 days followed by a 28-day off-treatment period. This cycle (28 days on treatment, 28 days off treatment) was to be repeated for up to 12 cycles, divided into 2 periods of 6 cycles each (approximately 12 months each). Receives: Drug: Liposomal amikacin for inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs) up to Day 672
Treatment emergent adverse events including serious adverse events (SAE) and adverse events (AE) leading to permanent discontinuation of study drug
Measured: From Study Initiation up to Day 672
Laboratory Abnormalities up to Day 672
- Number of Subjects with Grade 3 or Higher Abnormalities in Clinical Laboratory Values
- Number of Subjects with Grade 3 or Higher Hematology Laboratory Value Abnormalities
- Number of Subjects with Grade 3 or Higher Chemistry Laboratory Value Abnormalities
Measured: Baseline, Day 377 and Day 672
Acute Tolerability as Measured by Pulmonary Function Test (PFT) Changes Pre to Post Dose
Number of Subjects with a >15% in Decline in Forced Expiratory Volume in 1 Second (FEV1) From Predose to Postdose
Measured: Day 1, Day 84, Day 196, Day 281, Day 337, Day 449, Day 532 and Day 644
Respiratory Rate: Change From Baseline to Day 672
Respiratory rate was recorded at every visit as per standard practice at each investigational site.
Measured: From Study Initiation up to Day 672
Heart Rate: Change From Baseline From Day 672
Pulse rate (after at least 5-minute rest) was recorded at every visit as per standard practice at each investigational site.
Measured: From Study Initiation up to Day 672
Systolic BP: Change From Baseline at Day 672
Sitting blood pressure was recorded at every visit as per standard practice at each investigational site.
Measured: From Study Initiation up to Day 672
Diastolic BP: Change From Baseline at Day 672
Sitting blood pressure was recorded at every visit as per standard practice at each investigational site.
Measured: From Study Initiation up to Day 672
Body Temperature: Change From Baseline at Day 672
Body temperature was recorded at every visit as per standard practice at each investigational site.
Measured: From Study Initiation up to Day 672
Oxygen Saturation: Change From Baseline at Day 672
Change in oxygen saturation as measured with pulse oximetry was performed via finger probes placed on the extremity opposite arterial lines and noninvasive blood pressure monitoring devices so that pulsatile flow was not interrupted.
Measured: From Study Initiation up to Day 672
Minimum Inhibitory Concentrations (MICs) for Pseudomonas Aeruginosa (Pa) and Burkholderia Species From Day 1 to Days 169, 337, 505 and 672
Sputum was cultured for quantitative microbiological evaluation of Pa and Burkholderia species in designated regional central microbiology laboratories. A standard microbiology protocol was used for Pa culture and identification for each morphologically distinct Pa phenotype.
Although planned in the Statistical Analysis Plan (SAP), MICs of amikacin Burkholderia species were not determined due to the small number of isolates with Burkholderia. In addition, susceptibility testing of isolates of Pa and Burkholderia species against a panel of commonly used antipseudomonal antibiotics was planned but was not performed.
The results of the following analyses for Pa isolates are presented.
- Frequency of MIC of Amikacin
- Frequency of MIC of Tobramycin
MIC50: lowest concentration of the antibiotic at which 50 % of the isolates were inhibited.
Measured: Day 1, Day 169, Day 337, Day 505 and Day 672
Evaluation of Audiology
Hearing was evaluated using air conduction [AC]. Bone conduction was required if the AC testing demonstrated a decrease of >20 decibels [dB]. Hearing loss was categorized using Common Terminology Criteria for Adverse Events as follows: GRADE 1 (best): Adults [A] on a Monitoring Program [MP]: Threshold shift of 15-25 dB; Pediatric [P]: Threshold shift >20 dB at 8 kilohertz (kHz). GRADE 2: [A] on a MP: Threshold shift of >25 dB; [A] not enrolled in MP: hearing loss; hearing aid/intervention not indicated; [P]: Threshold shift >20 dB at 4 kHz and above. GRADE 3: [A] enrolled in MP: Threshold shift of >25 dB; therapeutic intervention indicated; [A]: Not enrolled in MP: hearing aid/intervention; [P]: therapeutic intervention, including hearing aids: Threshold shift >20 dB at 3 kHz and above; additional speech-language related services. GRADE 4 (worst): [A]: Profound bilateral hearing loss; non-serviceable hearing; [P]: cochlear implant \& additional speech-language related services.
Measured: Day 337 and Day 672
Change in Serum Creatinine Throughout the Study
- Common Terminology Criteria for Adverse Events (CTCAE) Grade 1: > ULN-1.5 × ULN
- CTCAE Grade 2: > 1.5 × ULN to 3.0 x ULN
Measured: Baseline, Day 337 and Day 672
Secondary outcomes (4)
Percent Change in FEV1 Throughout the Study
Percent Change From Baseline in Predose FEV1
Measured: Baseline, Day 337 and Day 672
Number of Subjects Experiencing a Protocol Defined Pulmonary Exacerbation
For number of subjects to first protocol-defined pulmonary exacerbation, follow-up time began at the first dose of study drug (Day 1) and ended no later than Day 700 (28-day follow up).
Measured: From Study Initiation up to Day 700
Number of Subjects Initiating Treatment.
The number of subjects initiating antipseudomonal therapy for protocol-defined pulmonary exacerbation confirmed by the investigator, and for investigator-defined pulmonary exacerbation were summarized.
The data presented below is the Frequency of Systemic or Inhaled Antipseudomonal Therapy for Protocol-defined Pulmonary Exacerbations Confirmed by Investigator
- Time to First Use of Any New Antibiotic Treatment, Censoring at Date of Last Contact
Measured: From Study Initiation up to Day 672
Number of Participants Who Received Antipseudomonal Antibiotic Treatment for Protocol Defined Pulmonary Exacerbation
Measured: From Study Initiation up to Day 700
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study start5 Oct 2012
- Primary completion16 Jul 2015
- Study completion16 Jul 2015
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 Cystic FibrosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 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
- NCT01316276
- Sponsor's protocol ID
- TR02-110
- Status last verified
- Jun 2020
- First submitted
- 14 Mar 2011
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bilton D, Fajac I, Pressler T, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Sole A, Quittner AL, Jumadilova Z, Ciesielska M, Konstan MW; CLEAR-110 Study Group. Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection. J Cyst Fibros. 2021 Nov;20(6):1010-1017. doi: 10.1016/j.jcf.2021.05.013. Epub 2021 Jun 16.
PubMed 34144923
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT01316276
- Acronym / sponsor ID
- TR02-110
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Respiratory Infections, Pulmonary Cystic Fibrosis, cystic fibrosis transmembrane conductance regulator (CFTR), Anti-bacterial Agent, Arikayce, ALIS, LAI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2012 (actual)
- Primary completion
- 16 Jul 2015 (actual)
- Study completion
- 16 Jul 2015 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of LAI were evaluated for up to approximately 2 years.
Detailed description
This was a long-term, open-label, multi-cycle extension study for patients in the Phase 3 study TR02-108 and TR02-109 who had successfully completed the 168-day study period and met study safety criteria. As this was a safety and tolerability long-term extension study, no sample size calculations were performed. All patients who completed TR02-108, were compliant with the study protocol, and did not meet any of the criteria listed for study discontinuation (safety reasons or non-compliance) were able to participate in this open-label study.
The end of study visit for TR02-108 was to serve as the baseline study visit (Day 1) for TR02-110 if the patient had signed the informed consent at least 4 days prior to the end of study visit and met all safety criteria for TR02-110. If the end of study visit was not used as the baseline visit, a separate baseline visit (Day 1) was to be performed within 14 days of completing TR02-108.
Patients were to receive a delivered dose of 590 mg LAI QD via a PARI Investigational eFlow® Nebulizer System (eFlow®) for 28 days followed by a 28-day off-treatment period. This cycle (28 days on treatment, 28 days off treatment) was to be repeated for up to 12 cycles. The study was implemented as 2 consecutive extension periods, each consisting of 48 weeks (approximately 12 months). Patients were re-consented for the second extension period at the completion of the first extension period. The total study period was up to 96 weeks (approximately 2 years).
During the first 28 days of treatment, patients were evaluated at the study site bi-weekly for safety, tolerability and efficacy. Thereafter, for the duration of the study, patients were evaluated at the study site on the first and last days of dosing during the on-treatment periods. During the study, starting with the off-treatment period of Cycle 1, patients were contacted by telephone once during every 28-day period to assess safety. A final site visit occurred 28 days after last dose of LAI. 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAI | Experimental | Drug: Liposomal amikacin for inhalation590 mg LAI QD via a PARI Investigational eFlow® Nebulizer System (eFlow®) for 28 days followed by a 28-day off-treatment period. This cycle (28 days on treatment, 28 days off treatment) was to be repeated for up to 12 cycles, divided into 2 periods of 6 cycles each (approximately 12 months each). |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent or assent
- Subject has completed study TR02-108, and has been compliant with the study protocol
- Women of childbearing potential must agree to use reliable methods of contraception for the duration of the study
Key exclusion criteria (5 listed)
- Subject met any of the listed criteria for study drug discontinuation in protocol TR02-108.
- Abnormal laboratory assessments including LFT (≥ 3× upper limit of normal [ULN]), serum creatinine (> 2× ULN) and absolute neutrophil count [ANC] (< 1000).
- Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
- History of alcohol, medication or illicit drug abuse within the 6 months prior to consent.
- Smoking tobacco or any substance within 6 months prior to consent or anticipated inability to refrain from smoking throughout the study
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* 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 in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment. | Drug | LAI |
Primary outcome
Treatment Emergent Adverse Events (TEAEs) up to Day 672
Time frame: From Study Initiation up to Day 672
Treatment emergent adverse events including serious adverse events (SAE) and adverse events (AE) leading to permanent discontinuation of study drug
Laboratory Abnormalities up to Day 672
Time frame: Baseline, Day 377 and Day 672
* Number of Subjects with Grade 3 or Higher Abnormalities in Clinical Laboratory Values * Number of Subjects with Grade 3 or Higher Hematology Laboratory Value Abnormalities * Number of Subjects with Grade 3 or Higher Chemistry Laboratory Value Abnormalities
Acute Tolerability as Measured by Pulmonary Function Test (PFT) Changes Pre to Post Dose
Time frame: Day 1, Day 84, Day 196, Day 281, Day 337, Day 449, Day 532 and Day 644
Number of Subjects with a >15% in Decline in Forced Expiratory Volume in 1 Second (FEV1) From Predose to Postdose
Respiratory Rate: Change From Baseline to Day 672
Time frame: From Study Initiation up to Day 672
Respiratory rate was recorded at every visit as per standard practice at each investigational site.
Heart Rate: Change From Baseline From Day 672
Time frame: From Study Initiation up to Day 672
Pulse rate (after at least 5-minute rest) was recorded at every visit as per standard practice at each investigational site.
Systolic BP: Change From Baseline at Day 672
Time frame: From Study Initiation up to Day 672
Sitting blood pressure was recorded at every visit as per standard practice at each investigational site.
Diastolic BP: Change From Baseline at Day 672
Time frame: From Study Initiation up to Day 672
Sitting blood pressure was recorded at every visit as per standard practice at each investigational site.
Body Temperature: Change From Baseline at Day 672
Time frame: From Study Initiation up to Day 672
Body temperature was recorded at every visit as per standard practice at each investigational site.
Oxygen Saturation: Change From Baseline at Day 672
Time frame: From Study Initiation up to Day 672
Change in oxygen saturation as measured with pulse oximetry was performed via finger probes placed on the extremity opposite arterial lines and noninvasive blood pressure monitoring devices so that pulsatile flow was not interrupted.
Minimum Inhibitory Concentrations (MICs) for Pseudomonas Aeruginosa (Pa) and Burkholderia Species From Day 1 to Days 169, 337, 505 and 672
Time frame: Day 1, Day 169, Day 337, Day 505 and Day 672
Sputum was cultured for quantitative microbiological evaluation of Pa and Burkholderia species in designated regional central microbiology laboratories. A standard microbiology protocol was used for Pa culture and identification for each morphologically distinct Pa phenotype. Although planned in the Statistical Analysis Plan (SAP), MICs of amikacin Burkholderia species were not determined due to the small number of isolates with Burkholderia. In addition, susceptibility testing of isolates of Pa and Burkholderia species against a panel of commonly used antipseudomonal antibiotics was planned but was not performed. The results of the following analyses for Pa isolates are presented. * Frequency of MIC of Amikacin * Frequency of MIC of Tobramycin MIC50: lowest concentration of the antibiotic at which 50 % of the isolates were inhibited.
Evaluation of Audiology
Time frame: Day 337 and Day 672
Hearing was evaluated using air conduction [AC]. Bone conduction was required if the AC testing demonstrated a decrease of >20 decibels [dB]. Hearing loss was categorized using Common Terminology Criteria for Adverse Events as follows: GRADE 1 (best): Adults [A] on a Monitoring Program [MP]: Threshold shift of 15-25 dB; Pediatric [P]: Threshold shift >20 dB at 8 kilohertz (kHz). GRADE 2: [A] on a MP: Threshold shift of >25 dB; [A] not enrolled in MP: hearing loss; hearing aid/intervention not indicated; [P]: Threshold shift >20 dB at 4 kHz and above. GRADE 3: [A] enrolled in MP: Threshold shift of >25 dB; therapeutic intervention indicated; [A]: Not enrolled in MP: hearing aid/intervention; [P]: therapeutic intervention, including hearing aids: Threshold shift >20 dB at 3 kHz and above; additional speech-language related services. GRADE 4 (worst): [A]: Profound bilateral hearing loss; non-serviceable hearing; [P]: cochlear implant \& additional speech-language related services.
Change in Serum Creatinine Throughout the Study
Time frame: Baseline, Day 337 and Day 672
* Common Terminology Criteria for Adverse Events (CTCAE) Grade 1: > ULN-1.5 × ULN * CTCAE Grade 2: > 1.5 × ULN to 3.0 x ULN
4 secondary outcomes
Percent Change in FEV1 Throughout the Study
Time frame: Baseline, Day 337 and Day 672
Number of Subjects Experiencing a Protocol Defined Pulmonary Exacerbation
Time frame: From Study Initiation up to Day 700
Number of Subjects Initiating Treatment.
Time frame: From Study Initiation up to Day 672
Number of Participants Who Received Antipseudomonal Antibiotic Treatment for Protocol Defined Pulmonary Exacerbation
Time frame: From Study Initiation up to Day 700
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34144923Bilton D, Fajac I, Pressler T, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Sole A, Quittner AL, Jumadilova Z, Ciesielska M, Konstan MW; CLEAR-110 Study Group. Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection. J Cyst Fibros. 2021 Nov;20(6):1010-1017. doi: 10.1016/j.jcf.2021.05.013. Epub 2021 Jun 16.
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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
50 sites in 17 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 in people with Cystic Fibrosis, run by Insmed Incorporated at 50 sites in 17 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 3 inclusion and 5 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 17 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 50 sites in Poland, Germany, Italy, Belgium, Bulgaria and 12 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 26 Jul 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?
Treatment Emergent Adverse Events (TEAEs) up to Day 672 (time frame: From Study Initiation up to Day 672). The study lists 12 primary outcomes in all. 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 NCT01316276, 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 17 Jun 2020.