Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647633
• Other study ID #: AkP 010112A
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 19, 2012
• Last updated: May 21, 2015
• Start date: May 2012
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Other:
• Calcium Glycerophosphate Nasal Spray Wash
Nasal wash two to six times per day

Locations

Country	Name	City	State
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	AkPharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Symptom Diary	Perceived improved comfort breathing is anticipated as primary outcome	28 days	No
Secondary	Spirometry	Anticipate change in spirometry	21 days	No