Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

Drexel University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Allergic Rhinitis

Treatments

Other: Calcium Glycerophosphate Nasal Spray Wash

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01647633

AkP 010112A

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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