Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis, Respiratory Infections, Pulmonary Cystic Fibrosis, CFTR
Brief summary
A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of patients with CF in the U.S. are infected. Liposomal amikacin for inhalation (LAI; Arikayce™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of infected patients when delivered via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug close to the bacterial colonies (Meers, et al., 2008) (Clancy, et al., 2013), thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating patients with CF with chronic infection caused by P. aeruginosa.
Detailed description
Cystic fibrosis (CF) is a genetic disease resulting from mutations in a 230 kb gene on chromosome 7 known as the cystic fibrosis transmembrane conductance regulator (CFTR). Patients with CF manifest pathological changes in a variety of organs that express CFTR. The lungs are frequently affected, the sequelae being chronic infections and airway inflammation. The principal goal of treatment of patients with CF is to slow the chronic deterioration of lung function. This study is a Phase 2 study to evaluate the longer term safety, tolerability and efficacy of 560 mg once daily dose of Arikayce™ administered for 6 cycles over 18 months. Each cycle comprises 28 days of treatment followed by 56 days off treatment. All study patients will receive study drug by inhalation via a PARI® eFlow nebulizer. All study patients will be followed for safety, pharmacokinetics (PK), clinical, and microbiologic activity for 28 days post completion of study treatment. The original TR02-105 study was a Phase 2a study of safety and tolerability of 28 days of daily dosing of two dose cohorts (280 mg and 560 mg) of Arikayce™ versus placebo. Study subjects were randomized to receive either study drug or placebo (1.5% NaCl) by inhalation via a PARI® eFlow nebulizer. Cohort 1 (280 mg) completed 28 days of daily dosing with Arikayce™ and 14-day post-dosing safety evaluation by the Safety Committee before initiation of enrollment in Cohort 2 (560 mg). Cohort 2 completed 28 days of daily dosing, and a 14-day post-dosing safety assessment by the Data Safety and Monitoring Board (DSMB) to evaluate safety data. All study patients were followed for safety, PK and clinical and microbiologic activity for 28 days post completion of study treatment. Details of the original study are provided at ClinicalTrials.gov ID NCT00777296. DSMB has recommended the amendment of the main study to evaluate safety and efficacy of additional cycles of treatment with Arikayce™. All patients who were randomized in the main study, were compliant with the study protocol, and continue meeting study eligibility criteria can be consented to participate in the open-label extension to evaluate the safety, tolerability, and efficacy of 560 mg once daily dose of Arikayce™ administered for 6 cycles over 18 months. Each cycle comprises 28 days of treatment followed by 56 days off treatment. Clinical laboratory parameters, audiology testing, clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the longer term safety, tolerability, and efficacy of Arikayce™. Serum specimens will be collected at periodic intervals to assess PK for safety. Additionally, sputum samples will be collected to determine changes in bacterial density. Pulmonary function testing and Cystic Fibrosis Questionnaire-Revised (CFQ-R) measurements will be assessed at selected time points throughout the study. 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.
Interventions
DRUGArikayce™
Amikacin (aminoglycoside) in a liposomal formulation.
Sponsors
Insmed Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Extension phase for evaluation of safety, tolerability and efficacy. Single dose group of 560 mg of Arikase TM
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent obtained from the patient or designated legal guardian prior to the performance of any study related procedures. 2. Male or female study subjects ≥ 6 years of age or older. 3. Confirmed diagnosis of CF defined as a positive sweat chloride \> 60 milliequivalents (mEq)/liter (by pilocarpine iontophoresis) and/or a genotype with 2 identifiable mutations consistent with CF accompanied by one or more clinical features of the CF phenotype. 4. History of chronic infection with P. aeruginosa (defined as 3 documented positive cultures in the prior 2 years of which at least one was obtained in the 3 months prior to randomization). The cultures could be obtained from the following respiratory secretions: sputum, throat swabs, nasopharyngeal swabs, or broncho-alveolar lavage fluid specimens. 5. Study subjects must produce a screening specimen (expectorated or induced sputum, throat swabs, nasopharyngeal swabs, or broncho-alveolar lavage fluid) that is positive for growth of P. aeruginosa. 6. FEV1 ≥ 40% of predicted at Screening. 7. SaO2 ≥ 90% at Screening while breathing room air. 8. Ability to comply with study medication use, study visits, and study procedures as judged by the investigator. 9. Ability to produce 0.5 grams sputum or be willing to undergo an induction to produce sputum for clinical evaluation. 10. Clinically stable with no evidence of acute upper or lower respiratory tract infection or history of pulmonary exacerbation within the 4 weeks prior to Screening. Main criteria for inclusion of patients participating in the 18-month extension period: 1. Written informed consent obtained from the patient or designated legal guardian prior to the performance of any study-related procedures in the extension period. 2. Patient meets all of the above listed inclusion criteria (1-10) of the main protocol.
Exclusion criteria
1. Administration of any investigational drug within 8 weeks prior to Screening. 2. Emergency room visit or hospitalization for CF or respiratory-related illness within the 4 weeks prior to Screening. 3. History of alcohol, medication, or illicit drug abuse within the 1 year prior to Screening. 4. History of lung transplantation. 5. 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). 6. Positive pregnancy test. All women of childbearing potential will be tested. 7. Use of any anti-pseudomonal antibiotics (IV antibiotics, all inhalation antibiotics, oral fluoroquinolones) within the 28 days prior to Screening. 8. Initiation of chronic therapy (i.e. TOBI®, high-dose ibuprofen, rhDNase, macrolide antibiotics) within the 28 days prior to Screening. 9. History of sputum or throat swab culture yielding Burkholderia cepacia within 2 years of Screening. 10. History of mycobacterial and/or Aspergillus infection requiring treatment within 2 years prior to Screening, and/or history of allergic bronchopulmonary aspergillosis (ABPA). 11. History of biliary cirrhosis with portal hypertension, or splenomegaly (refer to study manual). 12. GGT, AST, or ALT ≥ 3 times the upper limit of normal at Screening visit. 13. ANC ≤ 1000 performed at Screening visit. 14. Serum creatinine \> 1.5 times normal performed at Screening visit. 15. History of daily, continuous oxygen supplementation or requirement for more than 2 L/min at night. 16. Change in chest x-ray at Screening (or within the 3 months prior to Screening) with new onset infiltrates or that which compromise the safety of the study patient or the quality of the study data. Main criteria for exclusion of patients participating in the 18 months extension period: 1. Patient meets any criteria for exclusion as listed above in the main protocol. 2. Patient who met any criteria for study drug discontinuation in the main protocol (TR02-105).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | 18 Months | Number of Participants with indicated Adverse Events in subjects receiving 560 mg once daily dose of Arikayce™ administered for 6 cycles over 18 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 % Predicted | Baseline, Days1, 14, 28, 56, 70, 85, 98, 112, 140, 154, 169, 182,196, 224, 238, 253, 266, 280, 308, 322, 337, 350, 364, 392, 406, 421, 434, 448, 476, 490, and 504 | A summary of relative change from extension study baseline time points in FEV1 % predicted is presented for the overall safety population and by treatment received. |
| Absolute Change in Sputum Density | Baseline, Days 14, 28, 85, 98, 112, 140, 169, 182,196, 253, 266, 280, 337, 350, 364, 421, 434, and 448 | A summary of change from extension study baseline to all post-baseline time points during the treatment periods and at the end of the off-treatment periods in P aeruginosa sputum density (log10 CFU/mL) is presented for the overall safety population and by treatment received. |
| Antipseudomonal Rescue Therapy - Duration of Therapy | 18 Months | The duration of IV and all systemic or inhaled antipseudomonal rescue therapy is presented for the overall safety population and by treatment received. |
| Antipseudomonal Rescue Therapy - Time to Therapy | 18 Months | The time to IV and all systemic or inhaled antipseudomonal rescue therapy is presented for the overall safety population and by treatment received. |
| Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Days 14, 28, 85, 98, 112, 169, 182,196, 253, 266, 280, 337, 350, 364, 421, 434, and 448 | A summary of absolute change from baseline in the CFQ-R scales at each on-treatment assessment between Day 14 and Day 448 is presented for all patients and by main study treatment group for the safety population. CFQ-R is a disease specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms on a scale from 0 to 100 points. Higher values represent a more favorable outcome. |
Countries
Belgium, Hungary, North Macedonia, Poland, Serbia, Slovakia, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 560 mg Arikayce™ Subjects in this cohort will receive 560 mg of Arikayce™
Arikayce™: Amikacin (aminoglycoside) in a liposomal formulation. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Completed study but not 24 of 28 days | 2 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | 560 mg Arikayce™ |
|---|---|
| Age, Continuous | 17.4 years STANDARD_DEVIATION 6.22 |
| FEV1 % predicted | 59.73 Percent % STANDARD_DEVIATION 20.047 |
| P. aeruginosa density | 6.289 Log10 CFU/mL STANDARD_DEVIATION 2.8587 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 29 / 49 |
| serious Total, serious adverse events | 15 / 49 |
Outcome results
Primary
Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months.
Number of Participants with indicated Adverse Events in subjects receiving 560 mg once daily dose of Arikayce™ administered for 6 cycles over 18 months.
Time frame: 18 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 560 mg Arikayce™ | Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | Any Adverse Event | 48 participants |
| 560 mg Arikayce™ | Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | Treatment-related adverse events | 15 participants |
| 560 mg Arikayce™ | Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | Grade 1: Mild | 28 participants |
| 560 mg Arikayce™ | Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | Grade 2: Moderate | 15 participants |
| 560 mg Arikayce™ | Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | Grade 3: Severe | 4 participants |
| 560 mg Arikayce™ | Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | Grade 4: Life-threatening or disabling | 1 participants |
| 560 mg Arikayce™ | Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | Grade 5: Death | 0 participants |
| 560 mg Arikayce™ | Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | Serious Adverse Events | 15 participants |
| 560 mg Arikayce™ | Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | Treatment-related serious adverse events | 0 participants |
| 560 mg Arikayce™ | Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | Deaths | 0 participants |
| 560 mg Arikayce™ | Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months. | Permanent discontinuations due to adverse events | 1 participants |
Secondary
Absolute Change in Sputum Density
A summary of change from extension study baseline to all post-baseline time points during the treatment periods and at the end of the off-treatment periods in P aeruginosa sputum density (log10 CFU/mL) is presented for the overall safety population and by treatment received.
Time frame: Baseline, Days 14, 28, 85, 98, 112, 140, 169, 182,196, 253, 266, 280, 337, 350, 364, 421, 434, and 448
Population: Per Protocol population defined as all patients who completed at least 24 of the 28 days of dosing for each of the 6 cycles
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Baseline | 6.289 Log 10 CFU/mL | Standard Deviation 2.8587 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 14 | -1.196 Log 10 CFU/mL | Standard Deviation 2.0736 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 28 | -0.416 Log 10 CFU/mL | Standard Deviation 1.8584 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 85 | 0.154 Log 10 CFU/mL | Standard Deviation 2.4433 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 98 | -0.623 Log 10 CFU/mL | Standard Deviation 1.9127 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 112 | -0.781 Log 10 CFU/mL | Standard Deviation 1.1625 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 140 | -0.266 Log 10 CFU/mL | Standard Deviation 0.2871 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 169 | -0.144 Log 10 CFU/mL | Standard Deviation 1.247 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 182 | -1.087 Log 10 CFU/mL | Standard Deviation 1.9582 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 196 | -0.599 Log 10 CFU/mL | Standard Deviation 1.345 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 253 | 0.213 Log 10 CFU/mL | Standard Deviation 1.4059 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 266 | -0.991 Log 10 CFU/mL | Standard Deviation 2.504 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 280 | -0.702 Log 10 CFU/mL | Standard Deviation 1.7419 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 337 | 0.375 Log 10 CFU/mL | Standard Deviation 1.9924 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 350 | -0.311 Log 10 CFU/mL | Standard Deviation 1.6342 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 364 | -0.107 Log 10 CFU/mL | Standard Deviation 1.8027 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 421 | 0.494 Log 10 CFU/mL | Standard Deviation 2.0058 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 434 | 0.111 Log 10 CFU/mL | Standard Deviation 1.9098 |
| 560 mg Arikayce™ | Absolute Change in Sputum Density | Day 448 | 0.034 Log 10 CFU/mL | Standard Deviation 2.002 |
Secondary
Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score
A summary of absolute change from baseline in the CFQ-R scales at each on-treatment assessment between Day 14 and Day 448 is presented for all patients and by main study treatment group for the safety population. CFQ-R is a disease specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms on a scale from 0 to 100 points. Higher values represent a more favorable outcome.
Time frame: Days 14, 28, 85, 98, 112, 169, 182,196, 253, 266, 280, 337, 350, 364, 421, 434, and 448
Population: Per Protocol population defined as all patients who completed at least 24 of the 28 days of dosing for each of the 6 cycles
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 28 | 11.486 percentage % | Standard Deviation 14.9347 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 85 | 9.697 percentage % | Standard Deviation 12.9834 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 98 | 11.235 percentage % | Standard Deviation 14.5552 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 112 | 11.768 percentage % | Standard Deviation 13.9321 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 169 | 5.159 percentage % | Standard Deviation 13.6851 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 182 | 9.233 percentage % | Standard Deviation 16.3635 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 196 | 9.404 percentage % | Standard Deviation 12.4334 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 253 | 7.097 percentage % | Standard Deviation 13.7509 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 266 | 10.041 percentage % | Standard Deviation 14.524 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 280 | 6.111 percentage % | Standard Deviation 11.3611 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 337 | 9.017 percentage % | Standard Deviation 13.8786 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 350 | 12.108 percentage % | Standard Deviation 13.8668 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 364 | 11.875 percentage % | Standard Deviation 12.9679 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 421 | 11.895 percentage % | Standard Deviation 14.1632 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 434 | 13.718 percentage % | Standard Deviation 13.1377 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 448 | 13.120 percentage % | Standard Deviation 14.0144 |
| 560 mg Arikayce™ | Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score | Day 14 | 7.616 percentage % | Standard Deviation 14.1662 |
Secondary
Antipseudomonal Rescue Therapy - Duration of Therapy
The duration of IV and all systemic or inhaled antipseudomonal rescue therapy is presented for the overall safety population and by treatment received.
Time frame: 18 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 560 mg Arikayce™ | Antipseudomonal Rescue Therapy - Duration of Therapy | 39.7 days | Standard Deviation 44.57 |
Secondary
Antipseudomonal Rescue Therapy - Time to Therapy
The time to IV and all systemic or inhaled antipseudomonal rescue therapy is presented for the overall safety population and by treatment received.
Time frame: 18 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 560 mg Arikayce™ | Antipseudomonal Rescue Therapy - Time to Therapy | By Day 85 | 2.0 percentage % participants |
| 560 mg Arikayce™ | Antipseudomonal Rescue Therapy - Time to Therapy | By Day 253 | 17.2 percentage % participants |
| 560 mg Arikayce™ | Antipseudomonal Rescue Therapy - Time to Therapy | By Day 504 | 32.9 percentage % participants |
Secondary
FEV1 % Predicted
A summary of relative change from extension study baseline time points in FEV1 % predicted is presented for the overall safety population and by treatment received.
Time frame: Baseline, Days1, 14, 28, 56, 70, 85, 98, 112, 140, 154, 169, 182,196, 224, 238, 253, 266, 280, 308, 322, 337, 350, 364, 392, 406, 421, 434, 448, 476, 490, and 504
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 560 mg Arikayce™ | FEV1 % Predicted | Day 98 | 9.97 Percent (%) predicted | Standard Deviation 16.594 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 182 | 10.22 Percent (%) predicted | Standard Deviation 18.349 |
| 560 mg Arikayce™ | FEV1 % Predicted | Baseline | 59.73 Percent (%) predicted | Standard Deviation 20.047 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 1 | 3.13 Percent (%) predicted | Standard Deviation 8.553 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 14 | 7.62 Percent (%) predicted | Standard Deviation 15.246 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 28 | 6.83 Percent (%) predicted | Standard Deviation 14.593 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 56 | 3.02 Percent (%) predicted | Standard Deviation 11.174 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 70 | 2.96 Percent (%) predicted | Standard Deviation 13.58 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 85 | 4.04 Percent (%) predicted | Standard Deviation 15.45 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 112 | 8.19 Percent (%) predicted | Standard Deviation 20.116 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 140 | 4.86 Percent (%) predicted | Standard Deviation 19.337 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 154 | 6.76 Percent (%) predicted | Standard Deviation 20.633 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 169 | 3.90 Percent (%) predicted | Standard Deviation 19.141 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 196 | 7.56 Percent (%) predicted | Standard Deviation 20.607 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 224 | 2.57 Percent (%) predicted | Standard Deviation 19.165 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 238 | 5.46 Percent (%) predicted | Standard Deviation 17.872 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 253 | 3.37 Percent (%) predicted | Standard Deviation 17.755 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 266 | 9.07 Percent (%) predicted | Standard Deviation 19.747 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 280 | 8.54 Percent (%) predicted | Standard Deviation 19.179 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 308 | 5.77 Percent (%) predicted | Standard Deviation 19.633 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 322 | 5.25 Percent (%) predicted | Standard Deviation 20.946 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 337 | 5.18 Percent (%) predicted | Standard Deviation 21.74 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 350 | 10.49 Percent (%) predicted | Standard Deviation 21.615 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 364 | 3.82 Percent (%) predicted | Standard Deviation 18.895 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 392 | 3.07 Percent (%) predicted | Standard Deviation 18.38 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 406 | 2.74 Percent (%) predicted | Standard Deviation 18.301 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 421 | 1.63 Percent (%) predicted | Standard Deviation 19.094 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 434 | 7.11 Percent (%) predicted | Standard Deviation 20.022 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 448 | 5.66 Percent (%) predicted | Standard Deviation 20.422 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 476 | 0.83 Percent (%) predicted | Standard Deviation 21.741 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 490 | 1.61 Percent (%) predicted | Standard Deviation 19.922 |
| 560 mg Arikayce™ | FEV1 % Predicted | Day 504 | 0.06 Percent (%) predicted | Standard Deviation 22.196 |