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Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis (AIR-BX2)

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ClinicalTrials.gov Identifier: NCT01314716
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bronchiectasis
Interventions Drug: AZLI
Drug: Placebo
Enrollment 274
Recruitment Details Subjects were enrolled in a total of 90 study sites in the North America, Europe, and Australia. The first participant was screened on 25 April 2011. The last participant observation was on 01 July 2013.
Pre-assignment Details 404 participants were screened, 274 were randomized and comprise the Intent-to-Treat (ITT) Analysis Set. 272 randomized participants received at least one dose of study drug and comprise the Safety Analysis Set.
Arm/Group Title AZLI-AZLI Placebo-AZLI
Hide Arm/Group Description Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days. Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days.
Period Title: Double-Blind Phase
Started 136 138
Randomized and Treated 135 137
Completed 119 123
Not Completed 17 15
Reason Not Completed
Randomized but not treated             1             1
Adverse Event             10             4
Withdrawal by Subject             5             6
Lost to Follow-up             0             1
Sponsor request             1             2
Physician Decision             0             1
Period Title: Open-Label Phase
Started 112 [1] 110 [2]
Completed 102 98
Not Completed 10 12
Reason Not Completed
Adverse Event             4             6
Withdrawal by Subject             1             2
Physician Decision             5             4
[1]
7 participants in this group did not continue from the randomized to the open-label phase.
[2]
13 participants in this group did not continue from the randomized to the open-label phase.
Arm/Group Title AZLI-AZLI Placebo-AZLI Total
Hide Arm/Group Description Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up. Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up. Total of all reporting groups
Overall Number of Baseline Participants 136 138 274
Hide Baseline Analysis Population Description
ITT Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 136 participants 138 participants 274 participants
63.3  (14.22) 62.7  (13.33) 63.0  (13.75)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 138 participants 274 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
53
  39.0%
66
  47.8%
119
  43.4%
>=65 years
83
  61.0%
72
  52.2%
155
  56.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 138 participants 274 participants
Female
89
  65.4%
101
  73.2%
190
  69.3%
Male
47
  34.6%
37
  26.8%
84
  30.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 138 participants 274 participants
Hispanic or Latino
5
   3.7%
7
   5.1%
12
   4.4%
Not Hispanic or Latino
122
  89.7%
112
  81.2%
234
  85.4%
Unknown or Not Reported
9
   6.6%
19
  13.8%
28
  10.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 136 participants 138 participants 274 participants
White 119 128 247
American Indian or Alaska Native 1 1 2
Asian 1 0 1
Black or African Heritage 2 4 6
Other 2 1 3
Not permitted 11 4 15
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 136 participants 138 participants 274 participants
France 11 3 14
United States 58 52 110
Canada 0 2 2
Spain 22 17 39
Belgium 5 6 11
Australia 3 2 5
Netherlands 5 12 17
Germany 16 21 37
United Kingdom 11 11 22
Italy 5 12 17
QOL-B Respiratory Symptom Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 136 participants 138 participants 274 participants
56.2  (17.98) 57.4  (18.07) 56.8  (18.00)
[1]
Measure Description: The Quality of Life Questionnaire-Bronchiectasis (QOL-B) overall score was scaled from 0-100 with higher scores representing better quality of life.
1.Primary Outcome
Title Change in QOL-B Respiratory Symptoms Score at Day 28
Hide Description The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Time Frame Baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.
Arm/Group Title AZLI-AZLI Placebo-AZLI
Hide Arm/Group Description:
Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Overall Number of Participants Analyzed 128 132
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.2  (17.13) 3.2  (14.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZLI-AZLI, Placebo-AZLI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments P-value was based on T-test from mixed-effect model repeated measures (MMRM).
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Differences in least squares mean
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
1.1 to 8.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in QOL-B Respiratory Symptoms Score at Day 84
Hide Description The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Time Frame Baseline to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.
Arm/Group Title AZLI-AZLI Placebo-AZLI
Hide Arm/Group Description:
Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Overall Number of Participants Analyzed 123 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.6  (16.44) 3.9  (17.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZLI-AZLI, Placebo-AZLI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments P-value was based on T-test from mixed-effect model repeated measures (MMRM).
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares mean
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-2.7 to 5.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Protocol-Defined Exacerbation (PDE)
Hide Description

Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.

  • Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough
  • Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis
Time Frame Baseline to Day 112
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title AZLI-AZLI Placebo-AZLI
Hide Arm/Group Description:
Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
Overall Number of Participants Analyzed 136 138
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
At least 50% of participants must have had a PDE in order to compute the median days to PDE. Fewer than 50% of participants in this group had a PDE, so median days to PDE could not be computed.
Time Frame Baseline up to 30 days after the last dose of study drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZLI-AZLI (Double-Blind) Placebo-AZLI (Double-Blind) AZLI-AZLI (Open-Label) Placebo-AZLI (Open-Label)
Hide Arm/Group Description Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up. Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up. Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up. Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
All-Cause Mortality
AZLI-AZLI (Double-Blind) Placebo-AZLI (Double-Blind) AZLI-AZLI (Open-Label) Placebo-AZLI (Open-Label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZLI-AZLI (Double-Blind) Placebo-AZLI (Double-Blind) AZLI-AZLI (Open-Label) Placebo-AZLI (Open-Label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/135 (13.33%)   16/137 (11.68%)   8/112 (7.14%)   9/110 (8.18%) 
Cardiac disorders         
Cardiac failure  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Atrial fibrillation  1  1/135 (0.74%)  0/137 (0.00%)  1/112 (0.89%)  0/110 (0.00%) 
Endocrine disorders         
Hyperthyroidism  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Gastrointestinal disorders         
Abdominal pain upper  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Intestinal obstruction  1  0/135 (0.00%)  1/137 (0.73%)  0/112 (0.00%)  0/110 (0.00%) 
Gastrointestinal haemorrhage  1  0/135 (0.00%)  0/137 (0.00%)  0/112 (0.00%)  1/110 (0.91%) 
General disorders         
Device malfunction  1  0/135 (0.00%)  0/137 (0.00%)  1/112 (0.89%)  0/110 (0.00%) 
Infections and infestations         
Infective exacerbation of bronchiectasis  1  4/135 (2.96%)  2/137 (1.46%)  0/112 (0.00%)  3/110 (2.73%) 
Pneumonia  1  3/135 (2.22%)  2/137 (1.46%)  1/112 (0.89%)  1/110 (0.91%) 
Bronchitis  1  2/135 (1.48%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Diverticulitis  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Mycobacterium avium complex infection  1  0/135 (0.00%)  1/137 (0.73%)  0/112 (0.00%)  0/110 (0.00%) 
Fungal oesophagitis  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Lung infection pseudomonal  1  0/135 (0.00%)  1/137 (0.73%)  0/112 (0.00%)  0/110 (0.00%) 
Sinusitis  1  0/135 (0.00%)  1/137 (0.73%)  0/112 (0.00%)  0/110 (0.00%) 
Lung infection  1  0/135 (0.00%)  0/137 (0.00%)  1/112 (0.89%)  0/110 (0.00%) 
Gastroenteritis  1  0/135 (0.00%)  0/137 (0.00%)  1/112 (0.89%)  0/110 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Hip fracture  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Patella fracture  1  0/135 (0.00%)  1/137 (0.73%)  0/112 (0.00%)  0/110 (0.00%) 
Fall  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Wrist fracture  1  0/135 (0.00%)  1/137 (0.73%)  1/112 (0.89%)  0/110 (0.00%) 
Femur fracture  1  0/135 (0.00%)  0/137 (0.00%)  1/112 (0.89%)  0/110 (0.00%) 
Foot fracture  1  0/135 (0.00%)  0/137 (0.00%)  0/112 (0.00%)  1/110 (0.91%) 
Metabolism and nutrition disorders         
Hypoglycaemia  1  0/135 (0.00%)  0/137 (0.00%)  0/112 (0.00%)  1/110 (0.91%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Osteoarthritis  1  0/135 (0.00%)  1/137 (0.73%)  0/112 (0.00%)  0/110 (0.00%) 
Lumbar spinal stenosis  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Osteonecrosis  1  0/135 (0.00%)  0/137 (0.00%)  0/112 (0.00%)  1/110 (0.91%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast neoplasm  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Basal cell carcinoma  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Oesophageal adenocarcinoma  1  0/135 (0.00%)  0/137 (0.00%)  1/112 (0.89%)  0/110 (0.00%) 
Psychiatric disorders         
Depression  1  0/135 (0.00%)  0/137 (0.00%)  0/112 (0.00%)  1/110 (0.91%) 
Renal and urinary disorders         
Renal failure acute  1  0/135 (0.00%)  0/137 (0.00%)  1/112 (0.89%)  1/110 (0.91%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  2/135 (1.48%)  6/137 (4.38%)  0/112 (0.00%)  0/110 (0.00%) 
Asthma  1  1/135 (0.74%)  1/137 (0.73%)  0/112 (0.00%)  0/110 (0.00%) 
Lung disorder  1  1/135 (0.74%)  1/137 (0.73%)  0/112 (0.00%)  0/110 (0.00%) 
Dyspnoea  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  2/110 (1.82%) 
Haemoptysis  1  0/135 (0.00%)  1/137 (0.73%)  0/112 (0.00%)  0/110 (0.00%) 
Lung infiltration  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Respiratory failure  1  0/135 (0.00%)  0/137 (0.00%)  2/112 (1.79%)  0/110 (0.00%) 
Skin and subcutaneous tissue disorders         
Skin lesion  1  0/135 (0.00%)  1/137 (0.73%)  0/112 (0.00%)  0/110 (0.00%) 
Vascular disorders         
Hypertensive crisis  1  1/135 (0.74%)  0/137 (0.00%)  0/112 (0.00%)  0/110 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZLI-AZLI (Double-Blind) Placebo-AZLI (Double-Blind) AZLI-AZLI (Open-Label) Placebo-AZLI (Open-Label)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   112/135 (82.96%)   101/137 (73.72%)   54/112 (48.21%)   58/110 (52.73%) 
Gastrointestinal disorders         
Diarrhoea  1  6/135 (4.44%)  8/137 (5.84%)  0/112 (0.00%)  0/110 (0.00%) 
Nausea  1  7/135 (5.19%)  5/137 (3.65%)  0/112 (0.00%)  0/110 (0.00%) 
General disorders         
Fatigue  1  25/135 (18.52%)  25/137 (18.25%)  14/112 (12.50%)  16/110 (14.55%) 
Malaise  1  14/135 (10.37%)  19/137 (13.87%)  4/112 (3.57%)  6/110 (5.45%) 
Pyrexia  1  30/135 (22.22%)  21/137 (15.33%)  12/112 (10.71%)  16/110 (14.55%) 
Non-cardiac chest pain  1  9/135 (6.67%)  13/137 (9.49%)  5/112 (4.46%)  10/110 (9.09%) 
Chills  1  10/135 (7.41%)  3/137 (2.19%)  0/112 (0.00%)  0/110 (0.00%) 
Pain  1  0/135 (0.00%)  0/137 (0.00%)  7/112 (6.25%)  3/110 (2.73%) 
Infections and infestations         
Rhinitis  1  2/135 (1.48%)  7/137 (5.11%)  0/112 (0.00%)  0/110 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  6/135 (4.44%)  10/137 (7.30%)  0/112 (0.00%)  0/110 (0.00%) 
Nervous system disorders         
Headache  1  17/135 (12.59%)  14/137 (10.22%)  7/112 (6.25%)  11/110 (10.00%) 
Psychiatric disorders         
Insomnia  1  1/135 (0.74%)  7/137 (5.11%)  0/112 (0.00%)  0/110 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  66/135 (48.89%)  65/137 (47.45%)  27/112 (24.11%)  38/110 (34.55%) 
Sputum increased  1  59/135 (43.70%)  50/137 (36.50%)  19/112 (16.96%)  23/110 (20.91%) 
Sputum discoloured  1  48/135 (35.56%)  38/137 (27.74%)  21/112 (18.75%)  18/110 (16.36%) 
Dyspnoea  1  50/135 (37.04%)  47/137 (34.31%)  26/112 (23.21%)  28/110 (25.45%) 
Wheezing  1  18/135 (13.33%)  13/137 (9.49%)  11/112 (9.82%)  7/110 (6.36%) 
Haemoptysis  1  12/135 (8.89%)  11/137 (8.03%)  0/112 (0.00%)  0/110 (0.00%) 
Productive cough  1  7/135 (5.19%)  4/137 (2.92%)  0/112 (0.00%)  0/110 (0.00%) 
Oropharyngeal pain  1  12/135 (8.89%)  14/137 (10.22%)  0/112 (0.00%)  0/110 (0.00%) 
Throat irritation  1  7/135 (5.19%)  4/137 (2.92%)  0/112 (0.00%)  0/110 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01314716     History of Changes
Other Study ID Numbers: GS-US-219-0104
First Submitted: March 11, 2011
First Posted: March 14, 2011
Results First Submitted: March 7, 2014
Results First Posted: April 16, 2014
Last Update Posted: April 16, 2014