Clinical trial NCT01007253: Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution on Allergy Symptoms
Official title: Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution Alone and In Combination on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-11-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
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.

Eligibility criteria: Inclusion Criteria:

1. Males and females between 18 and 45 years of age.
2. History of grass and/or ragweed allergic rhinitis.
3. Positive skin test to grass and/or ragweed antigen.
4. Positive response to screening nasal challenge.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection within 14 days of study start.
4. forced expiratory volume at one second (FEV1) \<80% of predicted at screening for subjects with history of mild asthma.

Primary outcomes:
measure: Total Eye Symptoms Score Difference
timeFrame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Secondary outcomes:
measure: Total Nasal Symptoms Score Difference
timeFrame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
measure: Total Number of Sneezes
timeFrame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
measure: Change in Histamine Level (Across Nasal Challenges)
timeFrame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
measure: Change in Tryptase Level (Across Nasal Challenges)
timeFrame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
measure: Total Number of Eosinophils
timeFrame: 50 minutes [duration of 3 nasal challenges and 2 washout periods]
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Robert M Naclerio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baroody FM, Logothetis H, Vishwanath S, Bashir M, Detineo M, Naclerio RM. Effect of intranasal fluticasone furoate and intraocular olopatadine on nasal and ocular allergen-induced symptoms. Am J Rhinol Allergy. 2013 Jan;27(1):48-53. doi: 10.2500/ajra.2013.27.3841.