Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

This study is currently recruiting participants.

Verified July 2012 by Drexel University

Sponsor:

Collaborator:

AkPharma Inc.

Information provided by (Responsible Party):

Edward Schulman, Drexel University

ClinicalTrials.gov Identifier:

NCT01647633

First received: July 19, 2012

Last updated: July 20, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2012

Last Updated Date

July 20, 2012

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Nasal Symptom Diary [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Perceived improved comfort breathing is anticipated as primary outcome

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01647633 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Spirometry [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Anticipate change in spirometry

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Allergic Rhinitis

Intervention ^ICMJE

Other: Calcium Glycerophosphate Nasal Spray Wash

Nasal wash two to six times per day

Study Arm (s)

Experimental: Calcium Glycerophosphate Nasal Wash

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

Intervention: Other: Calcium Glycerophosphate Nasal Spray Wash

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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
Loratidine 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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Mary P Hendry, MS, RN	215 762 7499	mhendry@drexelmed.edu
Contact: Edward S Schulman, MD	215 762 7013	eschulma@drexelmed.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01647633

Other Study ID Numbers ^ICMJE

AkP 010112A

Has Data Monitoring Committee

Responsible Party

Edward Schulman, Drexel University

Study Sponsor ^ICMJE

Drexel University

Collaborators ^ICMJE

AkPharma Inc.

Investigators ^ICMJE

Principal Investigator:

Edward S Schulman, MD

Drexel University College of Medicine

Information Provided By

Drexel University

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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