Trial · NCT01315678
Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
NCT01315678, Phase 3, Completed, Insmed Incorporated; results first posted 2019-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections. Trials, record NCT01315678. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01315678
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
- NCT number
- NCT01315678
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 302 participants, actual
- Lead sponsor
- Insmed Incorporated
- Conditions
- Pseudomonas Aeruginosa Infection
- Interventions
- Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
- First posted
- 2011-03-15
- Last updated
- 2020-06-16
- Results first posted
- 2019-06-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | Baseline to168 days | Relative Change (%) from baseline to end of study (Day 168) in FEV1 (1 second) |
| Secondary | 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. | Relative changes (%) from baseline to Study Days 14, 28, 57, 84, 113, 140, 168 in FEV1 |
| Secondary | Number of Participants Experiencing a Pulmonary Exacerbation | 168 days | Number of participants experiencing a pulmonary exacerbation measured by number with event and number censored |
| Secondary | Number of Participants to First Antipseudomonal Antibiotic Treatment for Pulmonary Exacerbation | 168 days | Number of participants to first antipseudomonal antibiotic treatment for pulmonary exacerbation measured by number with event and number censored |
| Secondary | Number of Participants to First All Cause Hospitalization | 168 days | Number of participants to first all cause hospitalization measured by number with event and number censored |
| Secondary | 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 | Change in density (Log CFU) from baseline in Pseudomonas aeruginosa in sputum |
| Secondary | Relative Percent (%) Change in Respiratory Symptoms as Measured by the CFQ-R | Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168 | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | Baseline to168 days | The PP is the primary analysis population for the primary efficacy analysis | Percent (%) change | MEAN |
| SECONDARY | 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. | Modified intent-to-treat (mITT; received at least 1 dose of study drug) | percentage (%) change | MEAN |
| SECONDARY | Number of Participants Experiencing a Pulmonary Exacerbation | 168 days | Modified intent-to-treat (mITT; received at least 1 dose of study drug) | participants | NUMBER |
| SECONDARY | Number of Participants to First Antipseudomonal Antibiotic Treatment for Pulmonary Exacerbation | 168 days | Modified intent-to-treat (mITT; received at least 1 dose of study drug) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants to First All Cause Hospitalization | 168 days | Modified intent-to-treat (mITT; received at least 1 dose of study drug) | participants | NUMBER |
| SECONDARY | 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 | Modified intent-to-treat (mITT; received at least 1 dose of study drug) | Log 10 CFU | MEAN |
| SECONDARY | Relative Percent (%) Change in Respiratory Symptoms as Measured by the CFQ-R | Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168 | Modified intent-to-treat (mITT; received at least 1 dose of study drug) | Percent (%) change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | Arikayce™ | 0.47 | Standard Deviation 13.930 | Percent (%) change | |
| Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | TOBI® | 1.67 | Standard Deviation 16.050 | Percent (%) change | |
| Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | Arikayce™ | Day 14 | 2.59 | Standard Deviation 13.332 | percentage (%) change |
| Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | TOBI® | Day 14 | 6.64 | Standard Deviation 15.669 | percentage (%) change |
| Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | Arikayce™ | Day 28 | 0.79 | Standard Deviation 14.745 | percentage (%) change |
| Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | TOBI® | Day 28 | 3.32 | Standard Deviation 14.715 | percentage (%) change |
| Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | Arikayce™ | Day 57 | -3.49 | Standard Deviation 12.319 | percentage (%) change |
| Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | TOBI® | Day 57 | 0.70 | Standard Deviation 14.510 | percentage (%) change |
| Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | Arikayce™ | Day 84 | 0.44 | Standard Deviation 14.350 | percentage (%) change |
| Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) | TOBI® | Day 84 | 3.59 | Standard Deviation 14.642 | percentage (%) change |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arikayce™ | 148 | |
| Overall Study | STARTED | TOBI® | 146 | |
| Overall Study | COMPLETED | Arikayce™ | 134 | |
| Overall Study | COMPLETED | TOBI® | 140 | |
| Overall Study | NOT COMPLETED | Arikayce™ | 14 | |
| Overall Study | NOT COMPLETED | TOBI® | 6 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | diarrhoea | Gastrointestinal disorders | Arikayce™ | 10 | 148 | 12 |
| other | diarrhoea | Gastrointestinal disorders | TOBI® | 5 | 146 | 5 |
| other | Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | Arikayce™ | 82 | 148 | 138 |
| other | Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | TOBI® | 72 | 146 | 117 |
| other | Nasopharyngitis | Infections and infestations | Arikayce™ | 24 | 148 | 29 |
| other | Nasopharyngitis | Infections and infestations | TOBI® | 33 | 146 | 43 |
| other | Upper respiratory tract infection | Infections and infestations | Arikayce™ | 15 | 148 | 21 |
| other | Upper respiratory tract infection | Infections and infestations | TOBI® | 9 | 146 | 14 |
| other | Rhinitis | Infections and infestations | Arikayce™ | 9 | 148 | 10 |
| other | Rhinitis | Infections and infestations | TOBI® | 9 | 146 | 9 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arikayce™ | 0 | 148 |
| Total, all-cause mortality | TOBI® | 0 | 146 |
| Total, other adverse events | Arikayce™ | 114 | 148 |
| Total, other adverse events | TOBI® | 91 | 146 |
| Total, serious adverse events | Arikayce™ | 26 | 148 |
| Total, serious adverse events | TOBI® | 29 | 146 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31451351 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arikayce™ vs TOBI®: deaths from any cause | Trial comparisons |
| Arikayce™ vs TOBI®: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01315678
GET https://conductscience.org/api/trials/v1/NCT01315678/results?page=2