Clinical trial NCT01007253
Conditions: Seasonal Allergic Rhinitis
Sponsor: University of Chicago
Start date: 2009-11-01; Completion date: 2011-08-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Arms: arm 1: 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). arm 2: 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). arm 3: 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). arm 4: 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).
Interventions: intervention 1: PL nasal spray intervention 2: fluticasone furoate (FF) intervention 3: PL eye drops intervention 4: olopatadine (OLO)
Intervention descriptions: intervention 1: 2 puffs of PL nasal spray (from GlaxoSmithKline) in each nostril once a day for 1 week intervention 2: 2 puffs of FF nasal spray in each nostril once a day for 1 week intervention 3: 1 drop of placebo eye drops (lubricant eye drops with active ingredients 0.3% glycerin) in each eye once a day for 1 week intervention 4: 1 drop of OLO eye drops in each eye once a day for 1 week

Protocol documents: