Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Other: Calcium Glycerophosphate Nasal Spray Wash


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium Glycerophosphate Nasal Wash<br>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<br>* Nasal wash two to six times per day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Symptom Diary | Perceived improved comfort breathing is anticipated as primary outcome | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry | Anticipate change in spirometry | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rhinitis, stuffy nose, congestion, Sneezing