Trial · NCT01316276

Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection

NCT01316276, Phase 3, Completed, Insmed Incorporated; results first posted 2019-07-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection. Trials, record NCT01316276. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01316276

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
NCT number: NCT01316276
Status: Completed
Phases: Phase 3
Enrollment: 206 participants, actual
Lead sponsor: Insmed Incorporated
Conditions: Cystic Fibrosis
Interventions: Liposomal amikacin for inhalation
First posted: 2011-03-16
Last updated: 2020-06-17
Results first posted: 2019-07-26

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment Emergent Adverse Events (TEAEs) up to Day 672	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
Primary	Laboratory Abnormalities up to Day 672	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
Primary	Acute Tolerability as Measured by Pulmonary Function Test (PFT) Changes Pre to Post Dose	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
Primary	Respiratory Rate: Change From Baseline to Day 672	From Study Initiation up to Day 672	Respiratory rate was recorded at every visit as per standard practice at each investigational site.
Primary	Heart Rate: Change From Baseline From Day 672	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.
Primary	Systolic BP: Change From Baseline at Day 672	From Study Initiation up to Day 672	Sitting blood pressure was recorded at every visit as per standard practice at each investigational site.
Primary	Diastolic BP: Change From Baseline at Day 672	From Study Initiation up to Day 672	Sitting blood pressure was recorded at every visit as per standard practice at each investigational site.
Primary	Body Temperature: Change From Baseline at Day 672	From Study Initiation up to Day 672	Body temperature was recorded at every visit as per standard practice at each investigational site.
Primary	Oxygen Saturation: Change From Baseline at Day 672	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.
Primary	Minimum Inhibitory Concentrations (MICs) for Pseudomonas Aeruginosa (Pa) and Burkholderia Species From Day 1 to Days 169, 337, 505 and 672	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.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment Emergent Adverse Events (TEAEs) up to Day 672	From Study Initiation up to Day 672	Safety Population	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Laboratory Abnormalities up to Day 672	Baseline, Day 377 and Day 672	Safety Population	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Acute Tolerability as Measured by Pulmonary Function Test (PFT) Changes Pre to Post Dose	Day 1, Day 84, Day 196, Day 281, Day 337, Day 449, Day 532 and Day 644	Safety Population~Patients with missing values were excluded.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Respiratory Rate: Change From Baseline to Day 672	From Study Initiation up to Day 672	Safety Population Patients with missing data were excluded.	breaths per minute	MEAN
PRIMARY	Heart Rate: Change From Baseline From Day 672	From Study Initiation up to Day 672	Safety Population Patients with missing data were excluded.	beats/min	MEAN
PRIMARY	Systolic BP: Change From Baseline at Day 672	From Study Initiation up to Day 672	Safety Population Patients with missing data were excluded.	mmHg	MEAN
PRIMARY	Diastolic BP: Change From Baseline at Day 672	From Study Initiation up to Day 672	Safety Population Patients with missing data were excluded.	mmHg	MEAN
PRIMARY	Body Temperature: Change From Baseline at Day 672	From Study Initiation up to Day 672	Safety Population Patients with missing data were excluded.	Degrees Celcius	MEAN
PRIMARY	Oxygen Saturation: Change From Baseline at Day 672	From Study Initiation up to Day 672	Safety Population Patients with missing data were excluded.	Percent of Hemoglobin	MEAN
PRIMARY	Minimum Inhibitory Concentrations (MICs) for Pseudomonas Aeruginosa (Pa) and Burkholderia Species From Day 1 to Days 169, 337, 505 and 672	Day 1, Day 169, Day 337, Day 505 and Day 672	Safety Population~Patients with missing data were excluded.	µg/mL	MEDIAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group82

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Treatment Emergent Adverse Events (TEAEs) up to Day 672	LAI 590 mg QD	Patients with ≥1 treatment-emergent AE	183	Participants
Treatment Emergent Adverse Events (TEAEs) up to Day 672	LAI 590 mg QD	Patients with ≥ 1 serious AE	92	Participants
Treatment Emergent Adverse Events (TEAEs) up to Day 672	LAI 590 mg QD	Patients with ≥1 AE leading to discontinuation	21	Participants
Laboratory Abnormalities up to Day 672	LAI 590 mg QD	Baseline	13	Participants
Laboratory Abnormalities up to Day 672	LAI 590 mg QD	Day 337/End of Study Year 1	8	Participants
Laboratory Abnormalities up to Day 672	LAI 590 mg QD	Day 672/End of Study Year 2	8	Participants
Laboratory Abnormalities up to Day 672	LAI 590 mg QD	Leukocytes (<2.0 × 109 /L)	7	Participants
Laboratory Abnormalities up to Day 672	LAI 590 mg QD	Lymphocytes (<0.5 × 109 /L)	12	Participants
Laboratory Abnormalities up to Day 672	LAI 590 mg QD	Neutrophils (<2.0 × 109 /L)	23	Participants
Laboratory Abnormalities up to Day 672	LAI 590 mg QD	Platelets (<192 × 109 /L)	1	Participants

1 to 10 of 82Source ClinicalTrials.gov

See all 82 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	LAI 590 mg QD	206
Overall Study	COMPLETED	LAI 590 mg QD	139
Overall Study	NOT COMPLETED	LAI 590 mg QD	67

Source ClinicalTrials.gov

Adverse events45

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	LAI 590 mg QD	15	206	23
other	Pyrexia	General disorders	LAI 590 mg QD	13	206	15
other	Infective pulmonary exacerbation of cystic fibrosis	Infections and infestations	LAI 590 mg QD	129	206	359
other	Nasopharyngitis	Infections and infestations	LAI 590 mg QD	52	206	88
other	Upper respiratory tract infection	Infections and infestations	LAI 590 mg QD	32	206	64
other	Pharyngitis	Infections and infestations	LAI 590 mg QD	18	206	20
other	Rhinitis	Infections and infestations	LAI 590 mg QD	16	206	19
other	Sinusitis	Infections and infestations	LAI 590 mg QD	15	206	18
other	Viral infection	Infections and infestations	LAI 590 mg QD	15	206	15
other	Bronchitis	Infections and infestations	LAI 590 mg QD	11	206	15

1 to 10 of 45Source ClinicalTrials.gov

See all 45 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LAI 590 mg QD	1	206
Total, other adverse events	LAI 590 mg QD	167	206
Total, serious adverse events	LAI 590 mg QD	92	206

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34144923	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01316276

GET https://conductscience.org/api/trials/v1/NCT01316276/results?page=2

API reference For AI assistants