Allergic Conjunctivitis to Tree Pollen or Grass Pollen
Conditions
Brief summary
Rationale and objectives: Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when used for the treatment of seasonal allergic rhinitis during the ragweed pollen season. Although this is the only published report of an intranasal corticosteroid shown to effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the tears of patients with allergic conjunctivitis are known to have increased concentrations of cytokines and allergic mediators. The objective of this study is to determine if the positive effects of Veramyst nasal spray on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the amount of allergic mediators detected in their tears.
Interventions
2 sprays each nostril every morning for 2 weeks
DRUGPlacebo nasal spray
2 sprays each nostril every morning for 2 weeks
Sponsors
GlaxoSmithKline
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* a documented history of allergic rhinitis and conjunctivitis due to tree pollen and / or grass pollen for two allergy seasons * positive skin prick test to tree and / or grass
Exclusion criteria
* glaucoma * cataracts * acute or chronic sinusitis * asthma * chronic obstructive pulmonary disease * physical nasal obstruction * pregnant or breastfeeding * have had a viral or bacterial infections within 2 weeks of the study commencement * receiving allergen immunotherapy * have used inhaled corticosteroids within 14 days prior to the study * have used systemic corticosteroids within 30 days of the study * travel outside of the geographic area during the 2 week study period * use of contact lenses during the study period * use of artificial tears during the study period * use of eyewash irrigation during the study period * use of lubricants during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eosinophilic Cationic Protein (ECP) Levels | Samples taken at initial visit & 2 week follow-up | Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histamine Content in the Tears Was Measured. | Samples taken at initial visit & 2 week follow-up | Tear samples were assayed for histamine by ELISA |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited during the spring pollen season of 2009 at a large urban medcial center's allergy clinic.
Pre-assignment details
There was no run in period. All 20 participants that enrolled in this study were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Fluticasone Furoate Nasal Spray Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks | 10 |
| Placebo Nasal Spray Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Placebo Nasal Spray | Fluticasone Furoate Nasal Spray | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age Continuous | 29 years STANDARD_DEVIATION 8 | 32 years STANDARD_DEVIATION 7.3 | 30 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Eosinophilic Cationic Protein (ECP) Levels
Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.
Time frame: Samples taken at initial visit & 2 week follow-up
Population: Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.
Secondary
Histamine Content in the Tears Was Measured.
Tear samples were assayed for histamine by ELISA
Time frame: Samples taken at initial visit & 2 week follow-up
Population: All participants had tears measured for histamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Furoate Nasal Spray | Histamine Content in the Tears Was Measured. | 5.4 ng/ml | Standard Error 0.9 |
| Placebo Nasal Spray | Histamine Content in the Tears Was Measured. | 5.1 ng/ml | Standard Error 0.6 |
Comparison: paired t-test was used for the data analysisp-value: >0.1t-test, 2 sided
p-value: >0.1t-test, 2 sided