Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

Completed · Phase 1/Phase 2

Conditions studied: Allergic Rhinitis

In brief

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.

Key facts

Study ID

NCT01647633

Run by

Drexel University

People needed

17

Starts

2012-05-01

Expected to finish

2015-05-01

Last updated by the study team

2015-05-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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