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Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Calcium Glycerophosphate Nasal Spray Wash

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring rhinitis, stuffy nose, congestion, Sneezing

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Drexel University College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Calcium Glycerophosphate Nasal Wash

Arm Description

Nasal spray wash twice daily and up to four additional times per day as needed for nasal allergy symptoms

Outcomes

Primary Outcome Measures

Nasal Symptom Diary

Perceived improved comfort breathing is anticipated as primary outcome

Secondary Outcome Measures

Spirometry

Anticipate change in spirometry

Full Information

NCT ID

NCT01647633

First Posted

July 19, 2012

Last Updated

May 21, 2015

Sponsor

Drexel University

Collaborators

AkPharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01647633

Brief Title

Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Drexel University

Collaborators

AkPharma Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

rhinitis, stuffy nose, congestion, Sneezing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Calcium Glycerophosphate Nasal Wash

Arm Type

Experimental

Arm Description

Nasal spray wash twice daily and up to four additional times per day as needed for nasal allergy symptoms

Intervention Type

Other

Intervention Name(s)

Calcium Glycerophosphate Nasal Spray Wash

Intervention Description

Nasal wash two to six times per day

Primary Outcome Measure Information:

Title

Nasal Symptom Diary

Description

Perceived improved comfort breathing is anticipated as primary outcome

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Spirometry

Description

Anticipate change in spirometry

Time Frame

21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward S Schulman, MD

Organizational Affiliation

Drexel University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Drexel University College of Medicine

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102

Country

United States

12. IPD Sharing Statement

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Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

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