Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Other: Calcium Glycerophosphate Nasal Spray Wash

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calcium Glycerophosphate Nasal Wash; 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

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

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: AkPharma Inc.
• Investigators: Principal Investigator: Edward S Schulman, MD, Drexel University College of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 23, 2012

Study Record Updates

• Last Update Posted (Estimate): May 25, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Sneezing; rhinitis; congestion; stuffy nose
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: AkP 010112A