Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - 80
Updated:7/11/2015
Start Date:May 2012
End Date:June 2015
Contact:Mary P Hendry, MS, RN
Email:mhendry@drexelmed.edu
Phone:215 762 7499

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Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash on Patient-Perceived Breathing Comfort

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.

Inclusion Criteria:

- Male or Female 18-80 years of age

- Twelve months or more of allergic rhinitis symptoms

- Allergic antibodies to perennial aeroallergens to be confirmed by blood draw

Exclusion Criteria:

- Intranasal or systemic glucocorticosteroids within one month of study entry

- Intranasal cromolyn for 2 weeks prior to study

- Intranasal or systemic antihistamine for 3 days prior to the study

- Loratadine for ten days prior to study

- History of rhinitis medicamentosa

- 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

- Persons with Known sensitivity to Calcium or phosphorus supplements

- Persons taking antihistamine treatment intermittently. (Chronic steady use throughout
study is acceptable)

- Immunomodulatory or cytotoxic drugs

- Clinically significant uncontrolled disease that in the opinion of the investigator
would put the subject at risk or may confound the study interpretation

- Persons with hypercalcemia

- Persons whose nasal obstruction(s) would be significant to obstruct air flow

- Persons who are employees of Investigator or AkPharma or whose spouse, parent, child
or sibling is employee of investigator

- Pregnant persons or persons planning to conceive/inseminate partner during study or
for one month after
We found this trial at
1
site
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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Philadelphia, PA
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