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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01007253 |
Purpose
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 too 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: Veramyst /Artificial tears Drug: Veramyst / Artificial tears lubricant eye drops Drug: Veramyst nasal spray and Olopatadine eye drops Other: Veramyst placebo and Olopatadine0.2% eye drops |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Effect of Veramyst and Olopadatine 0.2% Opthalmic Solution Alone and In Combination on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen. |
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo/placebo
1 week treatment with placebo nasal spray and placebo eyedrops prior to nasal challenge
|
Drug: Veramyst /Artificial tears
2 puffs of nasal spray in each nostril once a day for 1 week; 1 drop of eye drops in each eye once a day for 1 week
|
|
Veramyst nasal spray/placebo eye drops
1 week treatment with active nasal spray and placebo eye drops prior to nasal challenge
|
Drug: Veramyst / Artificial tears lubricant eye drops
2 puffs of nasal spray in each nostril once a day for 1 week; 1 drop of eye drops in each eye once a day for 1 week
|
|
Placebo spray/Olopatadine eye drops
1 week treatment with placebo nasal spray and active eye drops prior to nasal challenge
|
Other: Veramyst placebo and Olopatadine0.2% eye drops
2 puffs of nasal spray in each nostril once a day for 1 week; 1 drop of eye drops in each eye once a day for 1 week
|
|
Active Comparator: Veramyst /Olopatadine eye drops
1 week treatment with active nasal spray and active eye drops prior to nasal challenge
|
Drug: Veramyst nasal spray and Olopatadine eye drops
2 puffs of nasal spray in each nostril once a day for 1 week; 1 drop of eye drops in each eye once a day for 1 week
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, Illinois | |
| The University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: | Robert M Naclerio, MD | University of Chicago |
More Information
| Responsible Party: | Robert M. Naclerio, MD, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01007253 History of Changes |
| Other Study ID Numbers: | 09-287-B |
| Study First Received: | November 3, 2009 |
| Last Updated: | June 15, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Tetrahydrozoline Fluticasone Olopatadine Nasal Decongestants Vasoconstrictor Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Bronchodilator Agents Anti-Asthmatic Agents Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists |