Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution on Allergy Symptoms

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier:
NCT01007253
First received: November 3, 2009
Last updated: June 12, 2013
Last verified: June 2013
Results First Received: March 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Condition: Seasonal Allergic Rhinitis
Interventions: Drug: PL nasal spray
Drug: fluticasone furoate (FF)
Drug: PL eye drops
Drug: olopatadine (OLO)

  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
Healthy patients age 18-50 completed an allergy questionnaire and underwent skin puncture testing for confirmation of allergy to grass or ragweed. Female subjects were given pregnancy tests. Patients who were eligible then underwent a screening nasal challenge with either grass or ragweed allergen depending on their skin test results and history.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a 2-week washout period, 21 subjects who had positive screening challenge returned to the Nasal Physiology Laboratory where they were randomized to receive one of four treatment orderings in this four-way crossover study.

Reporting Groups
  Description
FF/PL, PL/OLO, FF/OLO, PL/PL

Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:

  • fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)
  • PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),
  • FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), and
  • placebo (PL) nasal spray and PL eye drops (PL/PL).
PL/OLO, FF/OLO, PL/PL, FF/PL

Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:

  • PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),
  • FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),
  • placebo (PL) nasal spray and PL eye drops (PL/PL), and
  • fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL).
FF/OLO, PL/PL, FF/PL, PL/OLO

Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:

  • FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),
  • placebo (PL) nasal spray and PL eye drops (PL/PL),
  • fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL), and
  • PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO).
PL/PL, FF/PL, PL/OLO, FF/OLO

Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:

  • placebo (PL) nasal spray and PL eye drops (PL/PL),
  • fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL),
  • PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), and
  • FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO).

Participant Flow for 7 periods

Period 1:   First Intervention
    FF/PL, PL/OLO, FF/OLO, PL/PL     PL/OLO, FF/OLO, PL/PL, FF/PL     FF/OLO, PL/PL, FF/PL, PL/OLO     PL/PL, FF/PL, PL/OLO, FF/OLO  
STARTED     6     5     5     5  
COMPLETED     6     5     5     5  
NOT COMPLETED     0     0     0     0  

Period 2:   Washout Period (2 Weeks) # 1
    FF/PL, PL/OLO, FF/OLO, PL/PL     PL/OLO, FF/OLO, PL/PL, FF/PL     FF/OLO, PL/PL, FF/PL, PL/OLO     PL/PL, FF/PL, PL/OLO, FF/OLO  
STARTED     6     5     5     5  
COMPLETED     6     5     5     5  
NOT COMPLETED     0     0     0     0  

Period 3:   Second Intervention
    FF/PL, PL/OLO, FF/OLO, PL/PL     PL/OLO, FF/OLO, PL/PL, FF/PL     FF/OLO, PL/PL, FF/PL, PL/OLO     PL/PL, FF/PL, PL/OLO, FF/OLO  
STARTED     6     5     5     5  
COMPLETED     6     5     5     5  
NOT COMPLETED     0     0     0     0  

Period 4:   Washout Period (2 Weeks) # 2
    FF/PL, PL/OLO, FF/OLO, PL/PL     PL/OLO, FF/OLO, PL/PL, FF/PL     FF/OLO, PL/PL, FF/PL, PL/OLO     PL/PL, FF/PL, PL/OLO, FF/OLO  
STARTED     6     5     5     5  
COMPLETED     6     5     5     5  
NOT COMPLETED     0     0     0     0  

Period 5:   Third Intervention
    FF/PL, PL/OLO, FF/OLO, PL/PL     PL/OLO, FF/OLO, PL/PL, FF/PL     FF/OLO, PL/PL, FF/PL, PL/OLO     PL/PL, FF/PL, PL/OLO, FF/OLO  
STARTED     6     5     5     5  
COMPLETED     6     5     5     5  
NOT COMPLETED     0     0     0     0  

Period 6:   Washout Period (2 Weeks) # 3
    FF/PL, PL/OLO, FF/OLO, PL/PL     PL/OLO, FF/OLO, PL/PL, FF/PL     FF/OLO, PL/PL, FF/PL, PL/OLO     PL/PL, FF/PL, PL/OLO, FF/OLO  
STARTED     6     5     5     5  
COMPLETED     5     5     5     5  
NOT COMPLETED     1     0     0     0  
Physician Decision                 1                 0                 0                 0  

Period 7:   Fourth Intervention
    FF/PL, PL/OLO, FF/OLO, PL/PL     PL/OLO, FF/OLO, PL/PL, FF/PL     FF/OLO, PL/PL, FF/PL, PL/OLO     PL/PL, FF/PL, PL/OLO, FF/OLO  
STARTED     5     5     5     5  
COMPLETED     5     5     5     5  
NOT COMPLETED     0     0     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
Entire Study Population Includes groups randomized to receive PL/PL first, FF/PL first, PL/OLO first, and FF/OLO first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  21  
Age  
[units: years]
Mean ± Standard Deviation
  31.1  ± 6.89  
Gender  
[units: participants]
 
Female     7  
Male     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Eye Symptoms Score Difference   [ Time Frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods] ]

2.  Secondary:   Total Nasal Symptoms Score Difference   [ Time Frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods] ]

3.  Secondary:   Total Number of Sneezes   [ Time Frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods] ]

4.  Secondary:   Change in Histamine Level (Across Nasal Challenges)   [ Time Frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods] ]

5.  Secondary:   Change in Tryptase Level (Across Nasal Challenges)   [ Time Frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods] ]

6.  Secondary:   Total Number of Eosinophils   [ Time Frame: 50 minutes [duration of 3 nasal challenges and 2 washout periods] ]


  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
No text entered.


  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 M. Naclerio, MD
Organization: The University of Chicago
phone: (773) 702-1865
e-mail: rnacleri@surgery.bsd.uchicago.edu


Publications of Results:

Responsible Party: Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier: NCT01007253     History of Changes
Other Study ID Numbers: 09-287-B
Study First Received: November 3, 2009
Results First Received: March 26, 2013
Last Updated: June 12, 2013
Health Authority: United States: Food and Drug Administration