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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier:
NCT00791973
First received: November 13, 2008
Last updated: June 6, 2014
Last verified: June 2014
Results First Received: June 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Allergic Rhinitis
Interventions: Drug: fluticasone furoate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
24 subjects were screened for eligibility

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
15 of the 24 subjects screened were eligible for the study and were randomly assigned to groups

Reporting Groups
  Description
Veramyst, Then Placebo 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, Then Veramyst 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

Participant Flow for 3 periods

Period 1:   First Intervention (1 Week)
    Veramyst, Then Placebo     Placebo, Then Veramyst  
STARTED     8     7  
COMPLETED     8     7  
NOT COMPLETED     0     0  

Period 2:   Washout (1 Week)
    Veramyst, Then Placebo     Placebo, Then Veramyst  
STARTED     8     7  
COMPLETED     8     7  
NOT COMPLETED     0     0  

Period 3:   Second Intervention (1 Week)
    Veramyst, Then Placebo     Placebo, Then Veramyst  
STARTED     8     7  
COMPLETED     8     7  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Veramyst, Then Placbeo 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, Then Veramyst 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 Total of all reporting groups

Baseline Measures
    Veramyst, Then Placbeo     Placebo, Then Veramyst     Total  
Number of Participants  
[units: participants]
  8     7     15  
Age  
[units: years]
Mean ± Standard Deviation
  32  ± 11     29  ± 6     30  ± 9  
Gender  
[units: participants]
     
Female     3     4     7  
Male     5     3     8  
Region of Enrollment  
[units: participants]
     
United States     8     7     15  



  Outcome Measures
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1.  Primary:   Change in Tryptase Level From Baseline to Post-antigen Challenge   [ Time Frame: After one week of treatment wtih veramyst or placebo ]

2.  Secondary:   Total Eye Symptom Scores After Antigen Challenge   [ Time Frame: After one week of treatment wtih veramyst or placebo ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Robert Naclerio
Organization: University of Chicago
phone: (773) 702-0080
e-mail: rnacleri@surgery.bsd.uchicago.edu


No publications provided


Responsible Party: Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier: NCT00791973     History of Changes
Other Study ID Numbers: 16367B (OC 3)
Study First Received: November 13, 2008
Results First Received: June 6, 2014
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration