Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution on Allergy Symptoms
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      People who have hayfever or allergic rhinitis often complain about eye symptoms associated
      with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The
      purpose of this study is to better understand the generation of eye symptoms in patients with
      allergic rhinitis. We have previously shown that placing the substance that subjects are
      allergic to in their nose causes both nose and eye symptoms. This can be explain by a
      parasympathetic neurogenic reflex from the nose to the eye. Such a reflex would readily
      explain the tearing and watery eye symptoms, but does not explain the itch. In this study, we
      are going to address one possible explanation for the itch; does an axonal neurogenic reflex
      stimulate mast cells in the eye to release histamine, which then causes the itch? We will do
      this by placing an antihistamine drop in the eye and challenge the nose with allergen. We
      will also attempt to demonstrate that mast activation isn't effected by blocking the
      initiating of the reflex with a nasal steroid, as done in our previous study, and showing
      that the addition of an antihistamine does not add to the reduction of symptoms.
    

Detailed description: 
      We performed a randomized, double-blind, double-dummy, placebo-controlled, four-way crossover
      study in 21 subjects with seasonal allergic rhinitis studied out of season. Healthy patients,
      between 18 and 50 years of age, came to the Nasal Physiology Laboratory at The University of
      Chicago for screening, where they 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. The study
      was approved by the Institutional Review Board at The University of Chicago and all of the
      patients gave written informed consent before entry.

      After a 2-week washout period, after the screening challenge, 21 subjects who had positive
      screening challenge returned to the Nasal Physiology Laboratory where they were randomized to
      receive 1 week of one of four treatments:

        -  placebo (PL) nasal spray and PL eye drops (PL/PL),

        -  PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),

        -  fluticasone furoate (FF, also known as Veramyst) nasal spray and PL eye drops (FF/PL),
           and

        -  FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO).

      Specifically, the PL eye drops used were lubricant eye drops with active ingredients of 0.3%
      glycerin and 1.0% propylene glycol and the PL nasal spray was provided by GlaxoSmithKline.
      Treatment with OLO consisted of 1 drop of 0.2% OLO in each eye daily and treatment of FF
      consisted of 2 puffs in each nostril daily, giving a total of 110 micrograms delivered in
      each nostril. After a week of each of the treatments, the subjects returned to the Nasal
      Physiology Laboratory to undergo a nasal challenge. The subjects then returned the next day
      while still receiving treatment for another nasal challenge to augment the nasal ocular
      reflex. Next, the patients had a 2-week washout period and then switched over to the next
      randomized treatment arm. This sequence was repeated until subjects completed all four arms
      of the trial.
    

Intervention name(s): PL nasal spray; fluticasone furoate (FF); PL eye drops; olopatadine (OLO)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 puffs of PL nasal spray (from GlaxoSmithKline) in each nostril once a day for 1 week; 2 puffs of FF nasal spray in each nostril once a day for 1 week; 1 drop of placebo eye drops (lubricant eye drops with active ingredients 0.3% glycerin) in each eye once a day for 1 week; 1 drop of OLO eye drops in each eye once a day for 1 week
Other intervention name(s): Veramyst; Olopatadine 0.2% ophthalmic solution
Intervention MeSH terms: Fluticasone; Xhance; Olopatadine Hydrochloride; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)