A Phase 4 interventional study of Fluticasone furoate nasal spray and Placebo nasal spray in Allergic Conjunctivitis to Tree Pollen or Grass Pollen, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-03.
Sponsored by Rush University Medical Center · Phase 4, Interventional, and Treatment
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.
361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 299 interventional studies indexed under Conjunctivitis.
Browse Conjunctivitis studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
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Exclusion Criteria:
Drug: Placebo nasal spray
Drug: Fluticasone furoate nasal spray
2 sprays each nostril every morning for 2 weeks
Also known as: Veramyst
2 sprays each nostril every morning for 2 weeks
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
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
Subjects were recruited during the spring pollen season of 2009 at a large urban medcial center's allergy clinic.
| Milestone | Fluticasone Furoate Nasal Spray | Placebo Nasal Spray |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
Tear samples were assayed for histamine by ELISA
| ng/ml | Fluticasone Furoate Nasal Spray | Placebo Nasal Spray |
|---|---|---|
| Histamine Content in the Tears Was Measured. | 5.4 ± 0.9 | 5.1 ± 0.6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluticasone Furoate Nasal Spray | — | 0/10 (0%) | — |
| Placebo Nasal Spray | — | 0/10 (0%) | — |
| Age, Categorical(Participants) | Fluticasone Furoate Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Fluticasone Furoate Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|
| Mean | 32 ± 7.3 | 29 ± 8.0 | 30 ± 7.6 |
| Sex: Female, Male(Participants) | Fluticasone Furoate Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 4 | 6 | 10 |
| Region of Enrollment(participants) | Fluticasone Furoate Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Rush University Medical Center