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Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

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ClinicalTrials.gov Identifier: NCT00791973
Recruitment Status : Completed
First Posted : November 17, 2008
Results First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Allergic Rhinitis
Interventions Drug: fluticasone furoate
Drug: Placebo
Enrollment 15
Recruitment Details 24 subjects were screened for eligibility
Pre-assignment Details 15 of the 24 subjects screened were eligible for the study and were randomly assigned to groups
Arm/Group Title Veramyst, Then Placebo Placebo, Then Veramyst
Hide Arm/Group Description fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
Period Title: First Intervention (1 Week)
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Washout (1 Week)
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Second Intervention (1 Week)
Started 8 7
Completed 8 7
Not Completed 0 0
Arm/Group Title Veramyst, Then Placbeo Placebo, Then Veramyst Total
Hide Arm/Group Description fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week Total of all reporting groups
Overall Number of Baseline Participants 8 7 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 15 participants
32  (11) 29  (6) 30  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Female
3
  37.5%
4
  57.1%
7
  46.7%
Male
5
  62.5%
3
  42.9%
8
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 7 participants 15 participants
8 7 15
1.Primary Outcome
Title Change in Tryptase Level From Baseline to Post-antigen Challenge
Hide Description Tryptase levels (mcg/L) were measured from nasal lavages
Time Frame After one week of treatment wtih veramyst or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Veramyst Placebo
Hide Arm/Group Description:
fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
placebo nasal spray once daily (2 puffs/nostril) for a week
Overall Number of Participants Analyzed 15 15
Median (Inter-Quartile Range)
Unit of Measure: mcg/L
0
(0 to 11.8)
2.31
(0 to 8.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Veramyst, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
2.Secondary Outcome
Title Total Eye Symptom Scores After Antigen Challenge
Hide Description Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe
Time Frame After one week of treatment wtih veramyst or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Veramyst Placebo
Hide Arm/Group Description:
fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
placebo nasal spray once daily (2 puffs/nostril) for a week
Overall Number of Participants Analyzed 15 15
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
3
(0 to 4)
3
(1 to 9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Veramyst, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Veramyst Placebo
Hide Arm/Group Description fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week placebo nasal spray once daily (2 puffs/nostril) for a week
All-Cause Mortality
Veramyst Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Veramyst Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Veramyst Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Naclerio
Organization: University of Chicago
Phone: (773) 702-0080
EMail: rnacleri@surgery.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier: NCT00791973    
Other Study ID Numbers: 16367B (OC 3)
First Submitted: November 13, 2008
First Posted: November 17, 2008
Results First Submitted: June 6, 2014
Results First Posted: July 8, 2014
Last Update Posted: July 8, 2014