A Phase 1/2 interventional study of Calcium Glycerophosphate Nasal Spray Wash in Allergic Rhinitis, sponsored by Drexel University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-25.
Sponsored by Drexel University · Phase 1/2, Interventional, and Treatment
Over 20 million Americans have allergic nasal symptoms including stuffiness, sneezing and a "runny" nose. AkPharma's Calcium Glycerophosphate used as a nasal spray wash is believed to improve these symptoms without side effects common to over the counter and prescription medication. It is hypothesized that Calcium Glycerophosphate will have a perceived improvement in breathing comfort.
Subjects will be screened for inclusion and exclusion criteria and consented if they fit the same criteria. They will be instructed on keeping a nasal diary of symptoms "runny, itchy, congestion, sneezing, voice changes and throat clearing". They will have blood drawn for allergy testing. After a 1 week run-in, subjects will return their diary. If they still qualify based on the diary they will have baseline labs drawn and baseline breathing test (Spirometry) performed. They will also have a nasal wash and specimen collection performed. They will be instructed on use of the nasal wash. There will be three more weekly visits before study conclusion which will include diary submission, Spirometry and nasal wash and specimen collection. On the final visit blood will again be collected as well.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 17 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Drexel University is the lead sponsor of 110 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Planned travel outside the study area that will inhibit study follow-up visits
_Persons with Asthma with more than 2 episodes per week or month of nighttime awakenings
Nasal spray wash twice daily and up to four additional times per day as needed for nasal allergy symptoms
Other: Calcium Glycerophosphate Nasal Spray Wash
Nasal wash two to six times per day
Nasal Symptom Diary
Perceived improved comfort breathing is anticipated as primary outcome
Time frame: 28 days
Spirometry
Anticipate change in spirometry
Time frame: 21 days
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Drexel University