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Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.

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: NCT00775138
Recruitment Status : Completed
First Posted : October 17, 2008
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Bronchiectasis
Interventions Drug: 280 mg Arikayce™
Drug: Matching Placebo for Cohort 1
Drug: 560 mg Arikayce™
Drug: Matching Placebo for Cohort 2
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arikayce™ at 280 mg Matching Placebo (280 mg) Arikayce™ at 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description Study subjects will receive Arikayce™ 280 mg on Days 1-28. Study subjects will receive matching placebo on Days 1-28. Study subjects will receive Arikayce™ 560 mg on Days 1-28. Study subjects will receive matching placebo on Days 1-28.
Period Title: Overall Study
Started 24 10 20 10
Completed 24 10 17 8
Not Completed 0 0 3 2
Reason Not Completed
Withdrawal by Subject             0             0             2             2
Adverse Event             0             0             1             0
Arm/Group Title Arikayce™ at 280 mg Matching Placebo (280 mg) Arikayce™ at 560 mg Matching Placebo (560 mg) Total
Hide Arm/Group Description Study subjects will receive Arikayce™ 280 mg on Days 1-28. Study subjects will receive matching placebo on Days 1-28. Study subjects will receive Arikayce™ 560 mg on Days 1-28. Study subjects will receive matching placebo on Days 1-28. Total of all reporting groups
Overall Number of Baseline Participants 24 10 19 9 62
Hide Baseline Analysis Population Description
Modified intent-to-treat (mITT) population, defined as all randomized patients who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 10 participants 19 participants 9 participants 62 participants
49.9  (21.1) 46.8  (15.0) 58.5  (16.0) 52.3  (11.1) 52.4  (17.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 10 participants 19 participants 9 participants 62 participants
Female
10
  41.7%
4
  40.0%
11
  57.9%
5
  55.6%
30
  48.4%
Male
14
  58.3%
6
  60.0%
8
  42.1%
4
  44.4%
32
  51.6%
1.Primary Outcome
Title Number of Participants Reporting Treatment-emergent AEs (TEAEs) up to End of Treatment
Hide Description Number of Subjects reporting TEAE in the Arikayce™ groups and the placebo groups during the study. The table shows the events incidents, not the number of participants.
Time Frame Day 1 through 56.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.
Arm/Group Title Arikace™ 280 mg Matching Placebo (280 mg) Arikace™ 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description:
Study subjects will receive Arikace™ 280 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Study subjects will receive Arikace™ 560 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Overall Number of Participants Analyzed 24 10 19 9
Measure Type: Count of Participants
Unit of Measure: Participants
Productive Cough
2
   8.3%
3
  30.0%
2
  10.5%
3
  33.3%
Bronchial disorder
3
  12.5%
0
   0.0%
1
   5.3%
0
   0.0%
Cough
1
   4.2%
2
  20.0%
5
  26.3%
0
   0.0%
Haemoptysis
2
   8.3%
1
  10.0%
1
   5.3%
0
   0.0%
Pyrexia
2
   8.3%
1
  10.0%
1
   5.3%
2
  22.2%
Wheezing
1
   4.2%
2
  20.0%
1
   5.3%
0
   0.0%
Dyspnoea
0
   0.0%
2
  20.0%
3
  15.8%
1
  11.1%
Headache
1
   4.2%
1
  10.0%
4
  21.1%
1
  11.1%
Nasopharyngitis
1
   4.2%
1
  10.0%
1
   5.3%
0
   0.0%
Sneezing
0
   0.0%
2
  20.0%
0
   0.0%
0
   0.0%
Agitation
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
Aphthous stomatitis
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
Arthralgia
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
Cervicobrachial syndrome
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
Chronic obstructive pulmonary disease
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
Dizziness
0
   0.0%
1
  10.0%
1
   5.3%
0
   0.0%
Dysgeusia
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
Dysphonia
1
   4.2%
0
   0.0%
2
  10.5%
0
   0.0%
Forced expiratory volume decreased
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
Pharyngolaryngeal pain
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
Pruritus
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
Rash
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
Rhinorrhoea
0
   0.0%
1
  10.0%
0
   0.0%
1
  11.1%
Sinus bradycardia
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
Tinnitus
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
Toothache
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
Upper respiratory tract infection
1
   4.2%
0
   0.0%
1
   5.3%
0
   0.0%
Anorexia
0
   0.0%
0
   0.0%
1
   5.3%
1
  11.1%
Bronchiectasis
0
   0.0%
0
   0.0%
1
   5.3%
1
  11.1%
Fatigue
0
   0.0%
0
   0.0%
1
   5.3%
1
  11.1%
Insomnia
0
   0.0%
0
   0.0%
1
   5.3%
1
  11.1%
Abortion incomplete
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
Blood creatinine increased
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
Constipation
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
Laryngitis
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
Lung abscess
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
Nausea
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
Palpitations
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
2.Primary Outcome
Title Treatment-emergent Marked Laboratory Abnormalities up to 28 Days After Study Medication Discontinuation
Hide Description Number of subjects reporting Incidence of clinically significant abnormalities in clinical values (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 3) in Arikayce™ and placebo groups.
Time Frame Day 1 through 56.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population is the mITT population.
Arm/Group Title Arikace™ 280 mg Matching Placebo (280 mg) Arikace™ 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description:
Study subjects will receive Arikace™ 280 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Study subjects will receive Arikace™ 560 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Overall Number of Participants Analyzed 24 10 19 9
Measure Type: Count of Participants
Unit of Measure: Participants
Leukocytes
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils Abs
4
  16.7%
0
   0.0%
1
   5.3%
0
   0.0%
Sodium
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
Uric acid
0
   0.0%
1
  10.0%
1
   5.3%
1
  11.1%
3.Primary Outcome
Title Treatment-emergent Pulmonary Function Test (PFT) for Acute Tolerability Assessment
Hide Description Changes in PFT from pre-dose during the study were measured on Days 1, 14, and 28. Acute tolerability of the study treatment was assessed by examining the relative (rel.) changes in FEV1 from pre-dose assessments to 0-1 hour post-dose and 2-4 hours post-dose for each time point at which post-dose spirometry was conducted.
Time Frame Pre-dose, 0-1 hour post-dose and 2-4 hours post-dose on day 1, 0-1 hour post-dose and 2-4 hours post-dose on day 14, and 0-1 hour post-dose and 2-4 hours post-dose on day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is the safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.
Arm/Group Title Arikace™ 280 mg Matching Placebo (280 mg) Arikace™ 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description:
Study subjects will receive Arikace™ 280 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Study subjects will receive Arikace™ 560 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Overall Number of Participants Analyzed 24 10 19 9
Mean (Standard Deviation)
Unit of Measure: L
Day 1: Pre-Dose 1.917  (0.793) 1.841  (0.536) 1.939  (0.515) 1.758  (0.654)
Day 1: 0 - 1 Hr Post-Dose 1.922  (0.780) 1.820  (0.546) 1.907  (0.475) 1.807  (0.666)
Day 1: 2 - 4 Hrs Post-Dose 1.955  (0.766) 1.864  (0.520) 1.912  (0.477) 1.812  (0.675)
Day1:0-1 Hr Post-Dose Rel. Change from Pre-dose 0.816  (9.317) -1.186  (3.028) -0.873  (9.640) 3.128  (12.088)
Day1:2-4 Hrs Post-Dose Rel. Change from Pre-dose 3.323  (11.181) 1.484  (3.507) -0.661  (8.374) 3.082  (11.671)
Day 14: Pre-Dose 1.892  (0.759) 1.761  (0.550) 1.864  (0.607) 1.895  (0.592)
Day 14: 0 - 1 Hr Post-Dose 1.907  (0.776) 1.794  (0.556) 1.856  (0.555) 1.908  (0.611)
Day 14: 2 - 4 Hr Post-Dose 1.931  (0.771) 1.797  (0.520) 1.843  (0.567) 1.901  (0.542)
Day14:0-1 Hr Post-Dose Rel. Change from Pre-dose 0.800  (8.818) 2.061  (4.509) -1.629  (9.961) 0.589  (4.558)
Day14:2-4 Hr Post-Dose Rel. Change from Pre-dose 2.388  (9.020) 2.711  (6.620) -3.114  (8.506) 1.228  (9.617)
Day 28: Pre-Dose 1.919  (0.761) 1.794  (0.507) 1.846  (0.532) 1.934  (0.560)
Day 28: 0 - 1 Hr Post-Dose 1.928  (0.751) 1.803  (0.502) 1.797  (0.541) 1.901  (0.550)
Day 28: 2 - 4 Hrs Post-Dose 1.908  (0.754) 1.809  (0.527) 1.799  (0.578) 1.940  (0.641)
Day 28:0-1 Hr Post-Dose Rel. Change from Pre-dose 0.635  (7.647) 0.654  (3.675) 0.607  (4.185) -1.437  (6.454)
Day 28:2-4 Hrs Post-Dose Rel. Change from Pre-dose -0.356  (8.858) 0.601  (3.184) -0.006  (6.156) -0.542  (7.690)
4.Primary Outcome
Title Treatment-emergent PFT Abnormalities up to the End of Study
Hide Description Number of Subjects with Decrease of >= 15% in FEV1 (L) from Pre- to Post-dose by Study Day
Time Frame Day 1, Day 14 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is the safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.
Arm/Group Title Arikace™ 280 mg Matching Placebo (280 mg) Arikace™ 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description:
Study subjects will receive Arikace™ 280 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Study subjects will receive Arikace™ 560 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Overall Number of Participants Analyzed 24 10 19 9
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 No
22
  91.7%
10
 100.0%
17
  89.5%
9
 100.0%
Yes
2
   8.3%
0
   0.0%
2
  10.5%
0
   0.0%
Day 14 No
23
  95.8%
10
 100.0%
18
  94.7%
9
 100.0%
Yes
1
   4.2%
0
   0.0%
1
   5.3%
0
   0.0%
Day 28 No
23
  95.8%
10
 100.0%
19
 100.0%
9
 100.0%
Yes
1
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Subjects With an Adverse Event Leading to Permanent Discontinuation of Study Medication
Hide Description [Not Specified]
Time Frame Screening to Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is the safety population, the same as the mITT population, defined as all randomized patients who received at least 1 dose of study drug.
Arm/Group Title Arikace™ 280 mg Matching Placebo (280 mg) Arikace™ 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description:
Study subjects will receive Arikace™ 280 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Study subjects will receive Arikace™ 560 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Overall Number of Participants Analyzed 24 10 19 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
6.Primary Outcome
Title Serious Adverse Events up to 28 Days After Study Medication Discontinuation
Hide Description Number of subjects with a SAE in the Arikace™ groups and the placebo group up to 28 days after study medication discontinuation. See SAE table in the safety section for details.
Time Frame Screening to Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population is the modified intent-to-treat (mITT) population, defined as all randomized patients who received at least 1 dose of study drug.
Arm/Group Title Arikace™ 280 mg Matching Placebo (280 mg) Arikace™ 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description:
Study subjects will receive Arikace™ 280 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Study subjects will receive Arikace™ 280 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Overall Number of Participants Analyzed 24 10 19 9
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.2%
0
   0.0%
1
   5.3%
1
  11.1%
7.Secondary Outcome
Title Change From Baseline in Log10CFU Per Gram (Density) of Pseudomonas Aeruginosa in Sputum.
Hide Description The change in Pseudomonas aeruginosa density from from baseline to Day 14, 28, and 42 were evaluated.Treatment differences with respect to the changes from baseline to each measured study day, defined as the log10 of the sum of all morphotypes (colony-forming units [CFU]) per gram of sputum in (log10CFU/gram [g]), was estimated for each treatment group; standard deviations accompanied the treatment differences.
Time Frame Baseline to Day 14, Day 28 and Day 42.
Hide Outcome Measure Data
Hide Analysis Population Description
Per source, this is the Pa population, which includes patients who grew Pa on day 1, analyzed as treated.
Arm/Group Title Arikace™ 280 mg Matching Placebo (280 mg) Arikace™ 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description:
Study subjects will receive Arikace™ 280 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Study subjects will receive Arikace™ 560 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Overall Number of Participants Analyzed 17 9 15 8
Mean (Standard Deviation)
Unit of Measure: log10CFU per gram
Day 14 Change from Baseline -0.227  (0.805) -0.333  (0.515) -2.016  (1.942) -0.474  (1.942)
Day 28 Change from Baseline -0.094  (0.975) 0.315  (0.732) -1.013  (1.099) -0.302  (0.443)
Day 42 Change from Baseline 0.101  (0.788) -0.057  (0.627) 0.046  (0.705) -0.641  (1.095)
8.Secondary Outcome
Title Total Pulmonary Symptom Severity Score (PSSS)
Hide Description

Changes in the severity and intensity (frequency x severity) of individual symptoms and change in composite PSSS from baseline to Days 14, 28, 42 and 56.

The Pulmonary Symptom Severity Score (PSSS) was assessed on patient's responses to the Patients Symptoms Questionnaire, which employs symptom frequency and severity scales described for the validated Memorial Symptoms Assessment Scale. Symptom severity was scored on a scale of 0 (not applicable or symptom not present) to 4 (very severe) for each of the 5 symptoms (cough, shortness of breath, sputum production [frequency and severity], fatigue, and wheezing), and a composite score (range, 0 to 20 [low score represents better outcome]) was obtained as the sum of the severity scores for each symptom.

Time Frame Baseline to Day 14, Day 28, Day 42 and Day 56.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population is used for this analysis. It is the same as the mITT population, defined as all randomized patients who received at least one dose of study medication.
Arm/Group Title Arikace™ 280 mg Matching Placebo (280 mg) Arikace™ 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description:
Study subjects will receive Arikace™ 280 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Study subjects will receive Arikace™ 560 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Overall Number of Participants Analyzed 24 10 19 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 14 change from Day 1 -1.125  (2.213) -0.200  (0.789) -0.471  (2.035) -0.250  (2.053)
Day 28 change from Day 1 -2.167  (2.988) 0.000  (2.357) -1.000  (4.087) -0.125  (4.257)
Day 42 change from Day 1 -2.458  (3.476) -1.000  (1.491) -1.882  (4.285) 1.125  (3.137)
Day 56 change from Day 1 -2.458  (2.874) -1.500  (2.121) -2.167  (3.053) -2.000  (1.690)
9.Secondary Outcome
Title To Evaluate Change in St. George’s Respiratory Questionnaire Measurements
Hide Description A composite total score is derived as the sum of domain scores for symptoms, activity, and impact, with 0 as the best possible score and 100 as the worst possible score. A reduction in score of 4 points is generally recognized as a clinically meaningful improvement in quality of life. This analysis compared the changes from Day 1 (prior to first dosing) to Days 14, 28, 42, and 56.
Time Frame Day 1 to Day 14, Day 28, Day 42 and Day 56.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is the mITT population, defined as all randomized patients who received at least one dose of study medication.
Arm/Group Title Arikace™ 280 mg Matching Placebo (280 mg) Arikace™ 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description:
Study subjects will receive Arikace™ 280 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Study subjects will receive Arikace™ 560 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Overall Number of Participants Analyzed 24 10 19 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 14 change from Day 1 -4.024  (8.558) -6.350  (8.756) -6.101  (12.164) -2.807  (7.256)
Day 28 change from Day 1 -6.205  (13.661) -5.812  (12.039) -6.200  (11.855) -8.304  (12.993)
Day 42 change from Day 1 -7.611  (13.274) -6.130  (14.271) -8.196  (12.332) 0.242  (5.818)
Day 56 change from Day 1 -7.937  (16.281) -7.371  (11.270) -9.282  (10.302) -1.637  (15.161)
10.Secondary Outcome
Title To Evaluate the Use of Systemic Antipseudomonal Rescue Therapy
Hide Description [Not Specified]
Time Frame Screening to Day 56.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is the mITT population, defined as all randomized patients who received at least one dose of study medication
Arm/Group Title Arikace™ 280 mg Matching Placebo (280mg) Arikace™ 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description:
Study subjects will receive Arikace™ 280 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Study subjects will receive Arikace™ 560 mg on Days 1-28.
Study subjects will receive matching placebo on Days 1-28.
Overall Number of Participants Analyzed 24 10 19 9
Measure Type: Count of Participants
Unit of Measure: Participants
Rescue Medication Initiation by Day 28
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
Rescue Medication Initiation by Day 56
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
No Rescue Medication Initiation
24
 100.0%
10
 100.0%
19
 100.0%
7
  77.8%
Time Frame TEAEs were assessed at Baseline and all subsequent study visits up to day 56
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arikace at 280 mg Matching Placebo (280 mg) Arikace at 560 mg Matching Placebo (560 mg)
Hide Arm/Group Description Study subjects will receive Arikace™ 280 mg on Days 1-28. Study subjects will receive matching placebo on Days 1-28. Study subjects will receive Arikace™ 560 mg on Days 1-28. Study subjects will receive matching placebo on Days 1-28.
All-Cause Mortality
Arikace at 280 mg Matching Placebo (280 mg) Arikace at 560 mg Matching Placebo (560 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/10 (0.00%)      0/19 (0.00%)      0/9 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arikace at 280 mg Matching Placebo (280 mg) Arikace at 560 mg Matching Placebo (560 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/24 (4.17%)      0/10 (0.00%)      1/19 (5.26%)      1/9 (11.11%)    
Pregnancy, puerperium and perinatal conditions         
Abortion Incomplete  1  0/24 (0.00%)  0 0/10 (0.00%)  0 1/19 (5.26%)  1 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Chronic Obstructive Pulmonary Disease  1  1/24 (4.17%)  1 0/10 (0.00%)  0 0/19 (0.00%)  0 0/9 (0.00%)  0
Lung Abscess  1  0/24 (0.00%)  0 0/10 (0.00%)  0 0/19 (0.00%)  0 1/9 (11.11%)  1
1
Term from vocabulary, MedDRA (11.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arikace at 280 mg Matching Placebo (280 mg) Arikace at 560 mg Matching Placebo (560 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/24 (45.83%)      5/10 (50.00%)      11/19 (57.89%)      6/9 (66.67%)    
Cardiac disorders         
Palpitations  1  0/24 (0.00%)  0 0/10 (0.00%)  0 1/19 (5.26%)  1 0/9 (0.00%)  0
Sinus Bradycardia  1  0/24 (0.00%)  0 1/10 (10.00%)  1 0/19 (0.00%)  0 0/9 (0.00%)  0
Gastrointestinal disorders         
Aphthous Stomatitis  1  0/24 (0.00%)  0 1/10 (10.00%)  1 0/19 (0.00%)  0 0/9 (0.00%)  0
Constipation  1  0/24 (0.00%)  0 0/10 (0.00%)  0 0/19 (0.00%)  0 1/9 (11.11%)  1
Nausea  1  0/24 (0.00%)  0 0/10 (0.00%)  0 1/19 (5.26%)  1 0/9 (0.00%)  0
General disorders         
Pyrexia  1  2/24 (8.33%)  2 1/10 (10.00%)  1 1/19 (5.26%)  1 2/9 (22.22%)  3
Fatigue  1  0/24 (0.00%)  0 0/10 (0.00%)  0 1/19 (5.26%)  1 1/9 (11.11%)  1
Infections and infestations         
Nasopharyngitis  1  1/24 (4.17%)  1 1/10 (10.00%)  1 0/19 (0.00%)  0 1/9 (11.11%)  1
Bronchiectasis  1  0/24 (0.00%)  0 0/10 (0.00%)  0 1/19 (5.26%)  1 1/9 (11.11%)  1
Laryngitis  1  0/24 (0.00%)  0 0/10 (0.00%)  0 1/19 (5.26%)  1 0/9 (0.00%)  0
Respiratory Tract Infection  1  0/24 (0.00%)  0 0/10 (0.00%)  0 1/19 (5.26%)  1 0/9 (0.00%)  0
Investigations         
Blood Creatinine Increased  1  0/24 (0.00%)  0 0/10 (0.00%)  0 1/19 (5.26%)  1 0/9 (0.00%)  0
Heart Rate Increased  1  0/24 (0.00%)  0 0/10 (0.00%)  0 0/19 (0.00%)  0 1/9 (11.11%)  1
Metabolism and nutrition disorders         
Anorexia  1  0/24 (0.00%)  0 0/10 (0.00%)  0 1/19 (5.26%)  1 1/9 (11.11%)  1
Nervous system disorders         
Headache  1  1/24 (4.17%)  1 1/10 (10.00%)  3 4/19 (21.05%)  4 1/9 (11.11%)  2
Dizziness  1  0/24 (0.00%)  0 1/10 (10.00%)  21 1/19 (5.26%)  1 0/9 (0.00%)  0
Cervicobrachial Syndrome  1  0/24 (0.00%)  0 1/10 (10.00%)  1 0/19 (0.00%)  0 0/9 (0.00%)  0
Psychiatric disorders         
Insomnia  1  0/24 (0.00%)  0 0/10 (0.00%)  0 1/19 (5.26%)  1 1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders         
Productive Cough  1  2/24 (8.33%)  2 3/10 (30.00%)  4 2/19 (10.53%)  3 3/9 (33.33%)  3
Cough  1  1/24 (4.17%)  1 2/10 (20.00%)  4 5/19 (26.32%)  11 0/9 (0.00%)  0
Dyspnoea  1  0/24 (0.00%)  0 2/10 (20.00%)  3 3/19 (15.79%)  3 1/9 (11.11%)  1
Bronchial Disorder  1  3/24 (12.50%)  4 0/10 (0.00%)  0 1/19 (5.26%)  1 0/9 (0.00%)  0
Haemoptysis  1  2/24 (8.33%)  2 1/10 (10.00%)  1 1/19 (5.26%)  1 0/9 (0.00%)  0
Wheezing  1  1/24 (4.17%)  1 2/10 (20.00%)  3 1/19 (5.26%)  1 0/9 (0.00%)  0
Dysphonia  1  1/24 (4.17%)  1 0/10 (0.00%)  0 2/19 (10.53%)  2 0/9 (0.00%)  0
Rhinorrhoea  1  0/24 (0.00%)  0 1/10 (10.00%)  1 0/19 (0.00%)  0 1/9 (11.11%)  1
Sneezing  1  0/24 (0.00%)  0 2/10 (20.00%)  3 0/19 (0.00%)  0 1/9 (11.11%)  1
Skin and subcutaneous tissue disorders         
Pruritus  1  0/24 (0.00%)  0 1/10 (10.00%)  5 0/19 (0.00%)  0 0/9 (0.00%)  0
Rash  1  0/24 (0.00%)  0 1/10 (10.00%)  1 0/19 (0.00%)  0 0/9 (0.00%)  0
1
Term from vocabulary, MedDRA (11.1)
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.
Results Point of Contact
Name/Title: Dr. Kevin Mange, Sr. Vice President, Clinical Development
Organization: Insmed
Phone: 908-947-2651
Responsible Party: Insmed Incorporated
ClinicalTrials.gov Identifier: NCT00775138     History of Changes
Other Study ID Numbers: TR02-107
First Submitted: October 15, 2008
First Posted: October 17, 2008
Results First Submitted: April 3, 2019
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019