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Trial record 10 of 2402 for:    CARBON DIOXIDE

Market Potential of Carbon Dioxide Nasal Spray

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: NCT02113449
Recruitment Status : Completed
First Posted : April 14, 2014
Results First Posted : October 7, 2014
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Nasal Congestion
Intervention Drug: Carbon Dioxide
Enrollment 147
Recruitment Details Adult subjects with nasal congestion were recruited at the study sites from their volunteer database and through advertising.
Pre-assignment Details This was a 2-part study. In Part 1, recruited participants viewed a description of new treatment option (concept). Interested participants entered the trial. Eligible participants who consented received one dose of nasal CO2 in the clinic under medical supervision. Participants who wished to continue took the device home for 6 days (Part 2).
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
Period Title: Overall Study
Started 147
Completed 143
Not Completed 4
Reason Not Completed
Adverse Event             4
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
Overall Number of Baseline Participants 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants
51.7  (14.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
Female
97
  66.0%
Male
50
  34.0%
1.Primary Outcome
Title Which One Product That Relieves Nasal Congestion do You Buy Most Often?
Hide Description There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked as part of screening survey prior to concept viewing. If the participant answered "I do not purchase any product to relieve congestion" the participant was excluded. Participants could select only one option available.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that didnot perform well), and therefore 133 participants were included in PP population.
Arm/Group Title All Participants
Hide Arm/Group Description:
The participants were asked in the beginning which medication they purchase to relieve nasal congestion. Participant could select only one option available. If the participant answered "I do not purchase any product to relieve congestion" the participant was excluded. Participants could select only one option available.
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
Allergy medications 46
Medicated nasal sprays 29
Nasal rinses 6
Nasal strips 3
Non-medicated/saline nasal sprays/gels 14
Non-medicinal remedies 6
Sinus/cold medications 15
Prescription nasal sprays/inhalers 14
Prescription allergy medications 0
2.Primary Outcome
Title Which of the Statements Best Describes the Extent to Which the Spray Reached Your Expectations?
Hide Description There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first use. Participants could select only one option.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description:
CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
Much better than you expected 45
A little better than you expected 48
Just as you expected 27
Not as good as you expected 9
Not nearly as good as you expected 4
3.Primary Outcome
Title If the Product You Just Tried (After First Dose) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?
Hide Description There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description:
CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
Definitely would buy 29
Probably would buy 50
Might or might not buy 40
Probably would not buy 9
Definitely would not buy 5
4.Primary Outcome
Title Would You be Interested in Taking the Spray Product Home and Using it Over the Next Week?
Hide Description There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description:
CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
Yes 133
No 0
5.Primary Outcome
Title Which of the Following Statements Best Describes the Extent to Which the Spray Reached Your Expectations?
Hide Description There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description:
CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
Much better than your usual product 43
A little better 35
As good 22
Not quite as good 16
Not nearly as good 17
6.Primary Outcome
Title Divide 11 Points Between Two Products (CO2 Nasal Spray and Brand Selected at Q1)?
Hide Description There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option. It was done to compare the spray with the product selected by the participant in Q1. There were 11 points between the two products that participants could divide anyways thet wanted (11-0, 10-1, 9-2, 8-3, 7-4 or 6-5 etc). The more the participant liked a product compared to other, the higher the number of points were to be given to that product.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.
Arm/Group Title C02 Nasal Spray
Hide Arm/Group Description:
CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
0 for CO2 Nasal Spray 12
1 for CO2 Nasal Spray 4
2 for CO2 Nasal Spray 5
3 for CO2 Nasal Spray 5
4 for CO2 Nasal Spray 13
5 for CO2 Nasal Spray 13
6 for CO2 Nasal Spray 26
7 for CO2 Nasal Spray 19
8 for CO2 Nasal Spray 13
9 for CO2 Nasal Spray 11
10 for CO2 Nasal Spray 6
11 for CO2 Nasal Spray 6
7.Primary Outcome
Title If the Product You Just Tried (After At-home Use) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?
Hide Description There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
Definitely would buy 40
Probably would buy 38
Might or might not buy 21
Probably would not buy 18
Definitely would not buy 16
8.Primary Outcome
Title How Many Packages Would You Buy?
Hide Description There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience.This question was asked after at-home use of the product. Participants could select only one option.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description:
CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
1 54
2 20
3 6
4 1
5 1
Missing 51
9.Primary Outcome
Title Which One Statement Best Describes How Often, if Ever, You Think You Would Buy the Spray Product in the Future?
Hide Description There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description:
CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
More than once a week 43
Once a week 2
Once every 2 weeks 16
Once every 3 weeks 9
Once a month 30
Once every 6 weeks 10
Once every 2 months 12
Once every 3 months 7
Once every 4-5 months 4
10.Primary Outcome
Title How Often do You Think This Spray Product Would Last for You Personally?
Hide Description There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description:
CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
1 Week 2
2 Weeks 17
3 Weeks 17
1 Month 28
6 Weeks 15
2 Months 10
3 Months 4
4-5 Months 3
6 Months 3
9 Months 1
1 Year 6
More than 1 year 3
Missing 24
11.Primary Outcome
Title Provide a Score From 1-7 to Some Statements, Depending on How Much You Think Each Statement Applies or Does Not Apply to the Spray Product That You Used
Hide Description A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it. You can use any score from 1 to 7 to indicate how much or how little you think the statement applies to this product
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description:
Score from 1 to 7 indicates how much or how little you think the statement applies to this product. A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: Participants
Is easy to use; 1 2
Is easy to use; 2 2
Is easy to use; 3 5
Is easy to use; 4 5
Is easy to use; 5 22
Is easy to use; 6 15
Is easy to use; 7 82
Provides effective relief for nasal congestion; 1 10
Provides effective relief for nasal congestion; 2 7
Provides effective relief for nasal congestion; 3 10
Provides effective relief for nasal congestion; 4 11
Provides effective relief for nasal congestion; 5 21
Provides effective relief for nasal congestion; 6 21
Provides effective relief for nasal congestion; 7 53
Provides instant relief; 1 13
Provides instant relief; 2 7
Provides instant relief; 3 8
Provides instant relief; 4 13
Provides instant relief; 5 28
Provides instant relief; 6 24
Provides instant relief; 7 40
Provides long lasting relief; 1 13
Provides long lasting relief; 2 8
Provides long lasting relief; 3 16
Provides long lasting relief; 4 18
Provides long lasting relief; 5 16
Provides long lasting relief; 6 30
Provides long lasting relief; 7 32
Helps you breathe better; 1 9
Helps you breathe better; 2 6
Helps you breathe better; 3 7
Helps you breathe better; 4 12
Helps you breathe better; 5 15
Helps you breathe better; 6 26
Helps you breathe better; 7 58
Drug free; 1 7
Drug free; 2 1
Drug free; 3 2
Drug free; 4 5
Drug free; 5 8
Drug free; 6 12
Drug free; 7 98
Is a product for someone like me; 1 25
Is a product for someone like me; 2 5
Is a product for someone like me; 3 4
Is a product for someone like me; 4 4
Is a product for someone like me; 5 10
Is a product for someone like me; 6 19
Is a product for someone like me; 7 66
Prevents allergy symptoms; 1 24
Prevents allergy symptoms; 2 8
Prevents allergy symptoms; 3 13
Prevents allergy symptoms; 4 11
Prevents allergy symptoms; 5 18
Prevents allergy symptoms; 6 20
Prevents allergy symptoms; 7 39
Effectively treats allergy symptoms; 1 15
Effectively treats allergy symptoms; 2 8
Effectively treats allergy symptoms; 3 11
Effectively treats allergy symptoms; 4 11
Effectively treats allergy symptoms; 5 19
Effectively treats allergy symptoms; 6 27
Effectively treats allergy symptoms; 7 42
Is a brand I trust; 1 19
Is a brand I trust; 2 10
Is a brand I trust; 3 4
Is a brand I trust; 4 15
Is a brand I trust; 5 17
Is a brand I trust; 6 17
Is a brand I trust; 7 51
Is a good value for the money; 1 19
Is a good value for the money; 2 5
Is a good value for the money; 3 10
Is a good value for the money; 4 9
Is a good value for the money; 5 25
Is a good value for the money; 6 23
Is a good value for the money; 7 42
Is very effective; 1 14
Is very effective; 2 7
Is very effective; 3 6
Is very effective; 4 12
Is very effective; 5 19
Is very effective; 6 25
Is very effective; 7 50
Is safe to use every day; 1 15
Is safe to use every day; 2 6
Is safe to use every day; 3 8
Is safe to use every day; 4 7
Is safe to use every day; 5 12
Is safe to use every day; 6 27
Is safe to use every day; 7 58
Helps you sleep better; 1 29
Helps you sleep better; 2 7
Helps you sleep better; 3 6
Helps you sleep better; 4 10
Helps you sleep better; 5 16
Helps you sleep better; 6 17
Helps you sleep better; 7 48
Effectively treats multiple symptoms; 1 25
Effectively treats multiple symptoms; 2 10
Effectively treats multiple symptoms; 3 9
Effectively treats multiple symptoms; 4 10
Effectively treats multiple symptoms; 5 22
Effectively treats multiple symptoms; 6 25
Effectively treats multiple symptoms; 7 32
Does not cause side effects; 1 17
Does not cause side effects; 2 6
Does not cause side effects; 3 8
Does not cause side effects; 4 13
Does not cause side effects; 5 15
Does not cause side effects; 6 19
Does not cause side effects; 7 55
Helps you feel better the next day; 1 23
Helps you feel better the next day; 2 9
Helps you feel better the next day; 3 10
Helps you feel better the next day; 4 9
Helps you feel better the next day; 5 20
Helps you feel better the next day; 6 24
Helps you feel better the next day; 7 38
Helps you breathe more freely; 1 10
Helps you breathe more freely; 2 8
Helps you breathe more freely; 3 6
Helps you breathe more freely; 4 6
Helps you breathe more freely; 5 15
Helps you breathe more freely; 6 24
Helps you breathe more freely; 7 64
Does not interact with any medications; 1 13
Does not interact with any medications; 2 1
Does not interact with any medications; 3 4
Does not interact with any medications; 4 5
Does not interact with any medications; 5 10
Does not interact with any medications; 6 21
Does not interact with any medications; 7 79
Safe to use multiple times in a day; 1 14
Safe to use multiple times in a day; 2 9
Safe to use multiple times in a day; 3 3
Safe to use multiple times in a day; 4 6
Safe to use multiple times in a day; 5 17
Safe to use multiple times in a day; 6 17
Safe to use multiple times in a day; 7 67
Prevents the release of histamine; 1 23
Prevents the release of histamine; 2 6
Prevents the release of histamine; 3 5
Prevents the release of histamine; 4 9
Prevents the release of histamine; 5 16
Prevents the release of histamine; 6 28
Prevents the release of histamine; 7 46
Prevents nasal congestion before it starts; 1 20
Prevents nasal congestion before it starts; 2 11
Prevents nasal congestion before it starts; 3 10
Prevents nasal congestion before it starts; 4 12
Prevents nasal congestion before it starts; 5 26
Prevents nasal congestion before it starts; 6 22
Prevents nasal congestion before it starts; 7 32
Stops nasal congestion where it starts; 1 16
Stops nasal congestion where it starts; 2 9
Stops nasal congestion where it starts; 3 5
Stops nasal congestion where it starts; 4 10
Stops nasal congestion where it starts; 5 21
Stops nasal congestion where it starts; 6 28
Stops nasal congestion where it starts; 7 44
Can be used with other nasal congestion remedy; 1 24
Can be used with other nasal congestion remedy; 2 4
Can be used with other nasal congestion remedy; 3 6
Can be used with other nasal congestion remedy; 4 8
Can be used with other nasal congestion remedy; 5 16
Can be used with other nasal congestion remedy; 6 24
Can be used with other nasal congestion remedy; 7 51
Can feel it working instantly; 1 13
Can feel it working instantly; 2 7
Can feel it working instantly; 3 6
Can feel it working instantly; 4 8
Can feel it working instantly; 5 11
Can feel it working instantly; 6 30
Can feel it working instantly; 7 58
Works like no other product; 1 14
Works like no other product; 2 3
Works like no other product; 3 7
Works like no other product; 4 10
Works like no other product; 5 15
Works like no other product; 6 31
Works like no other product; 7 53
Relieves my symptoms instantly; 1 16
Relieves my symptoms instantly; 2 4
Relieves my symptoms instantly; 3 11
Relieves my symptoms instantly; 4 10
Relieves my symptoms instantly; 5 16
Relieves my symptoms instantly; 6 30
Relieves my symptoms instantly; 7 46
Improves my breathing instantly; 1 14
Improves my breathing instantly; 2 7
Improves my breathing instantly; 3 10
Improves my breathing instantly; 4 9
Improves my breathing instantly; 5 16
Improves my breathing instantly; 6 31
Improves my breathing instantly; 7 46
Works as good as medicated nasal sprays; 1 21
Works as good as medicated nasal sprays; 2 6
Works as good as medicated nasal sprays; 3 10
Works as good as medicated nasal sprays; 4 6
Works as good as medicated nasal sprays; 5 15
Works as good as medicated nasal sprays; 6 23
Works as good as medicated nasal sprays; 7 52
Works better than medicated nasal sprays; 1 23
Works better than medicated nasal sprays; 2 5
Works better than medicated nasal sprays; 3 10
Works better than medicated nasal sprays; 4 6
Works better than medicated nasal sprays; 5 15
Works better than medicated nasal sprays; 6 26
Works better than medicated nasal sprays; 7 48
Time Frame Adverse events were collected from the start of the investigational product, and until 3 days following last administration of the investigational product.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CO2 Nasal Spray
Hide Arm/Group Description CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
All-Cause Mortality
CO2 Nasal Spray
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CO2 Nasal Spray
Affected / at Risk (%) # Events
Total   0/147 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
CO2 Nasal Spray
Affected / at Risk (%) # Events
Total   75/147 (51.02%)    
Eye disorders   
Lacrimation increased   11/147 (7.48%)  18
Gastrointestinal disorders   
Abdominal distension   2/147 (1.36%)  2
General disorders   
Application site pain   9/147 (6.12%)  18
Medical device site reaction   3/147 (2.04%)  4
Nervous system disorders   
Paraesthesia   12/147 (8.16%)  22
Headache   10/147 (6.80%)  10
Respiratory, thoracic and mediastinal disorders   
Nasal discomfort   37/147 (25.17%)  75
Throat irritation   7/147 (4.76%)  10
Epistaxis   6/147 (4.08%)  6
Rhinalgia   4/147 (2.72%)  5
Rhinorrhoea   4/147 (2.72%)  4
Cough   2/147 (1.36%)  2
Oropharyngeal pain   2/147 (1.36%)  2
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02113449     History of Changes
Other Study ID Numbers: 202181
RH01910 ( Other Identifier: GSK )
First Submitted: February 6, 2014
First Posted: April 14, 2014
Results First Submitted: October 2, 2014
Results First Posted: October 7, 2014
Last Update Posted: April 30, 2015