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Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01315678
Recruitment Status : Completed
First Posted : March 15, 2011
Results First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pseudomonas Aeruginosa Infection
Interventions Drug: Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.
Drug: Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
Enrollment 302
Recruitment Details 302 participants were randomized. 8 were not treated.
Pre-assignment Details  
Arm/Group Title Arikayce™ TOBI®
Hide Arm/Group Description

Arikayce™ is liposomal amikacin for inhalation

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.

TOBI® is tobramycin inhalation solution

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
Period Title: Overall Study
Started [1] 148 146
Completed 134 140
Not Completed 14 6
Reason Not Completed
Withdrawal by Subject             7             3
Adverse Event             3             1
Lost to Follow-up             1             0
similar reason to those listed above             3             2
[1]
Number of participants treated
Arm/Group Title Arikayce™ TOBI® Total
Hide Arm/Group Description

Arikayce™ is liposomal amikacin for inhalation

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.

TOBI® is tobramycin inhalation solution

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
Total of all reporting groups
Overall Number of Baseline Participants 148 146 294
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 148 participants 146 participants 294 participants
6-12 years
27
  18.2%
26
  17.8%
53
  18.0%
>12-18 years
34
  23.0%
33
  22.6%
67
  22.8%
>18 years
87
  58.8%
87
  59.6%
174
  59.2%
[1]
Measure Analysis Population Description: Modified intent-to-treat (mITT; received at least 1 dose of study drug)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 146 participants 294 participants
Female
69
  46.6%
70
  47.9%
139
  47.3%
Male
79
  53.4%
76
  52.1%
155
  52.7%
[1]
Measure Analysis Population Description: Modified intent-to-treat (mITT; received at least 1 dose of study drug)
Race/Ethnicity, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 148 participants 145 participants 293 participants
Caucasian
139
  93.9%
141
  97.2%
280
  95.6%
Hispanic
5
   3.4%
3
   2.1%
8
   2.7%
African
1
   0.7%
0
   0.0%
1
   0.3%
Other
3
   2.0%
1
   0.7%
4
   1.4%
[1]
Measure Description: In TOBI arm , one patient was not recorded for ethnicity.
[2]
Measure Analysis Population Description: Modified intent-to-treat (mITT; received at least 1 dose of study drug)
1.Primary Outcome
Title Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Relative Change (%) from baseline to end of study (Day 168) in FEV1 (1 second)
Time Frame Baseline to168 days
Hide Outcome Measure Data
Hide Analysis Population Description
The PP is the primary analysis population for the primary efficacy analysis
Arm/Group Title Arikayce™ TOBI®
Hide Arm/Group Description:

Arikayce™ is liposomal amikacin for inhalation

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.

TOBI® is tobramycin inhalation solution

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
Overall Number of Participants Analyzed 129 137
Mean (Standard Deviation)
Unit of Measure: Percent (%) change
0.47  (13.930) 1.67  (16.050)
2.Secondary Outcome
Title Pumonary Function Test: Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Relative changes (%) from baseline to Study Days 14, 28, 57, 84, 113, 140, 168 in FEV1
Time Frame Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT; received at least 1 dose of study drug)
Arm/Group Title Arikayce™ TOBI®
Hide Arm/Group Description:

Arikayce™ is liposomal amikacin for inhalation

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.

TOBI® is tobramycin inhalation solution

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
Overall Number of Participants Analyzed 148 146
Mean (Standard Deviation)
Unit of Measure: percentage (%) change
Day 14 Number Analyzed 142 participants 131 participants
2.59  (13.332) 6.64  (15.669)
Day 28 Number Analyzed 114 participants 114 participants
0.79  (14.745) 3.32  (14.715)
Day 57 Number Analyzed 132 participants 131 participants
-3.49  (12.319) 0.70  (14.510)
Day 84 Number Analyzed 110 participants 104 participants
0.44  (14.350) 3.59  (14.642)
Day 113 Number Analyzed 127 participants 132 participants
-0.90  (12.028) 0.42  (14.434)
Day 140 Number Analyzed 103 participants 105 participants
0.43  (15.299) 1.37  (16.563)
Day 168 Number Analyzed 133 participants 137 participants
-0.12  (14.326) 1.58  (15.970)
3.Secondary Outcome
Title Number of Subjects Experiencing a Pulmonary Exacerbation
Hide Description Number of Subjects experiencing a pulmonary exacerbation measured by number with event and number censored
Time Frame 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT; received at least 1 dose of study drug)
Arm/Group Title Arikayce™ TOBI®
Hide Arm/Group Description:

Arikayce™ is liposomal amikacin for inhalation

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.

TOBI® is tobramycin inhalation solution

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
Overall Number of Participants Analyzed 148 146
Measure Type: Number
Unit of Measure: participants
Number with Event 73 63
Number Censored 75 83
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arikayce™, TOBI®
Comments Stratified Cox proportional hazards model
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0286
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.07 to 2.13
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Subjects to First Antipseudomonal Antibiotic Treatment for Pulmonary Exacerbation
Hide Description Number of Subjects to first antipseudomonal antibiotic treatment for pulmonary exacerbation measured by number with event and number censored
Time Frame 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT; received at least 1 dose of study drug)
Arm/Group Title Arikayce™ TOBI®
Hide Arm/Group Description:

Arikayce™ is liposomal amikacin for inhalation

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.

TOBI® is tobramycin inhalation solution

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
Overall Number of Participants Analyzed 148 146
Measure Type: Count of Participants
Unit of Measure: Participants
Number with Event
55
  37.2%
48
  32.9%
Number Censored
93
  62.8%
98
  67.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arikayce™, TOBI®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6031
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.76 to 1.66
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Subjects to First All Cause Hospitalization
Hide Description Number of Subjects to first all cause hospitalization measured by number with event and number censored
Time Frame 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT; received at least 1 dose of study drug)
Arm/Group Title Arikayce™ TOBI®
Hide Arm/Group Description:

Arikayce™ is liposomal amikacin for inhalation

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.

TOBI® is tobramycin inhalation solution

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
Overall Number of Participants Analyzed 148 146
Measure Type: Number
Unit of Measure: participants
Number with Event 24 29
Number Censored 124 117
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arikayce™, TOBI®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4861
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.49 to 1.44
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Density (Log CFU) in Pseudomonas Aeruginosa in Sputum
Hide Description Change in density (Log CFU) from baseline in Pseudomonas aeruginosa in sputum
Time Frame Baseline, Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT; received at least 1 dose of study drug)
Arm/Group Title Arikayce™ TOBI®
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 148 146
Mean (Standard Deviation)
Unit of Measure: Log 10 CFU
Baseline Number Analyzed 134 participants 131 participants
6.872  (1.8806) 6.510  (2.3202)
14 days Number Analyzed 131 participants 120 participants
-1.124  (2.0542) -1.663  (2.4017)
28 days Number Analyzed 129 participants 120 participants
-1.208  (2.1594) -1.453  (2.4440)
57 days Number Analyzed 122 participants 120 participants
-0.210  (1.9874) -0.098  (1.7446)
84 days Number Analyzed 120 participants 119 participants
-0.945  (2.2223) -1.182  (2.6914)
113 days Number Analyzed 114 participants 118 participants
-0.613  (2.1928) -0.135  (2.3461)
140 days Number Analyzed 117 participants 116 participants
-1.440  (2.4357) -1.315  (2.2300)
168 days Number Analyzed 117 participants 118 participants
-0.725  (2.0073) -0.136  (2.1750)
7.Secondary Outcome
Title Relative Percent (%) Change in Respiratory Symptoms as Measured by the CFQ-R
Hide Description 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.
Time Frame Day 14, Day 28, Day 57, Day 84, Day 113, Day 140 and Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT; received at least 1 dose of study drug)
Arm/Group Title Arikayce™ TOBI®
Hide Arm/Group Description:

Arikayce™ is liposomal amikacin for inhalation

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.

TOBI® is tobramycin inhalation solution

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
Overall Number of Participants Analyzed 148 146
Least Squares Mean (Standard Error)
Unit of Measure: Percent (%) change
Day 14 Number Analyzed 141 participants 136 participants
13.65  (2.995) 8.81  (3.019)
Day 28 Number Analyzed 143 participants 138 participants
15.54  (3.363) 11.03  (3.419)
Day 57 Number Analyzed 137 participants 134 participants
8.00  (3.120) 7.97  (3.146)
Day 84 Number Analyzed 136 participants 135 participants
13.20  (3.079) 8.55  (3.111)
Day 113 Number Analyzed 131 participants 135 participants
3.58  (3.323) 5.03  (3.290)
Day 140 Number Analyzed 130 participants 135 participants
13.84  (3.060) 6.10  (3.079)
Day 168 Number Analyzed 128 participants 131 participants
12.06  (3.784) 8.07  (3.790)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arikayce™ TOBI®
Hide Arm/Group Description

Arikayce™ is liposomal amikacin for inhalation

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.

TOBI® is tobramycin inhalation solution

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
All-Cause Mortality
Arikayce™ TOBI®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/148 (0.00%)      0/146 (0.00%)    
Hide Serious Adverse Events
Arikayce™ TOBI®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/148 (17.57%)      29/146 (19.86%)    
Gastrointestinal disorders     
Distal intestinal obstruction syndrome   1/148 (0.68%)  1 1/146 (0.68%)  1
Dyspepsia   1/148 (0.68%)  1 1/146 (0.68%)  1
Haematochezia   0/148 (0.00%)  0 1/146 (0.68%)  1
Infections and infestations     
Infective pulmonary exacerbation of cystic fibrosis   24/148 (16.22%)  28 23/146 (15.75%)  28
Pneumonia   0/148 (0.00%)  0 2/146 (1.37%)  2
Bronchitis   0/148 (0.00%)  0 1/146 (0.68%)  1
Bronchopulmonary aspergillosis allergic   1/148 (0.68%)  1 0/146 (0.00%)  0
Chronic sinusitis   1/148 (0.68%)  1 0/146 (0.00%)  0
Investigations     
Forced expiratory volume decreased   1/148 (0.68%)  1 0/146 (0.00%)  0
Pulmonary function test decreased   0/148 (0.00%)  0 1/146 (0.68%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchial secretion retention   1/148 (0.68%)  1 0/146 (0.00%)  0
Bronchiectasis   1/148 (0.68%)  1 0/146 (0.00%)  0
Haemoptysis   0/148 (0.00%)  0 1/146 (0.68%)  1
Pneumothorax   0/148 (0.00%)  0 1/146 (0.68%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arikayce™ TOBI®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   125/148 (84.46%)      115/146 (78.77%)    
Gastrointestinal disorders     
diarrhoea   10/148 (6.76%)  12 5/146 (3.42%)  5
General disorders     
General disorders   20/148 (13.51%)  23 10/146 (6.85%)  13
Infections and infestations     
Infective pulmonary exacerbation of cystic fibrosis   82/148 (55.41%)  138 72/146 (49.32%)  117
Nasopharyngitis   24/148 (16.22%)  29 33/146 (22.60%)  43
Upper respiratory tract infection   15/148 (10.14%)  21 9/146 (6.16%)  14
Rhinitis   9/148 (6.08%)  10 9/146 (6.16%)  9
Investigations     
Investigations   12/148 (8.11%)  15 10/146 (6.85%)  11
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective   12/148 (8.11%)  14 10/146 (6.85%)  12
Nervous system disorders     
Headache   12/148 (8.11%)  22 5/146 (3.42%)  8
Respiratory, thoracic and mediastinal disorders     
Haemoptysis   24/148 (16.22%)  53 10/146 (6.85%)  21
Cough   18/148 (12.16%)  23 11/146 (7.53%)  24
Dysphonia   18/148 (12.16%)  28 8/146 (5.48%)  9
Oropharyngeal pain   11/148 (7.43%)  12 6/146 (4.11%)  7
Skin and subcutaneous tissue disorders     
Skin and subcutaneous   8/148 (5.41%)  10 5/146 (3.42%)  6
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Per the signed Investigator Agreement in the study protocol and protocol amendments, the PI agreed "not to originate or use the name of Insmed Incorporated, or study drug code in any publicity, news release, or other public announcement, written or oral, whether to the public, press, or otherwise, relating to this protocol, to any amendment to the protocol, or to the performance of this protocol, without the prior written consent of Insmed Incorporated."
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kevin Mange (Senior VP, Clinical Development and Medical Affairs)
Organization: Insmed Incorporated
Phone: 908-947-2651
EMail: kevin.mange@insmed.com
Layout table for additonal information
Responsible Party: Insmed Incorporated
ClinicalTrials.gov Identifier: NCT01315678    
Other Study ID Numbers: TR02-108
First Submitted: March 14, 2011
First Posted: March 15, 2011
Results First Submitted: April 3, 2019
Results First Posted: June 24, 2019
Last Update Posted: June 24, 2019