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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
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
 Other: Calcium Glycerophosphate Nasal Spray Wash
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash on Patient-Perceived Breathing Comfort

Resource links provided by NLM:

MedlinePlus related topics: Calcium
U.S. FDA Resources

Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Nasal Symptom Diary [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Perceived improved comfort breathing is anticipated as primary outcome


Secondary Outcome Measures:
  • Spirometry [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Anticipate change in spirometry


Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647633

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

Locations
United States, Pennsylvania
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Mary P Hendry, MS, RN     215-762-7499     mhendry@drexelmed.edu    
Contact: Edward S Schulman, MD     215 762 7013     eschulma@drexelmed.edu    
Principal Investigator: Edward S Schulman, MD            
Sponsors and Collaborators
Drexel University
AkPharma Inc.
Investigators
Principal Investigator: Edward S Schulman, MD Drexel University College of Medicine
  More Information

No publications provided

Responsible Party: Edward Schulman, MD, PI, Drexel University
ClinicalTrials.gov Identifier: NCT01647633     History of Changes
Other Study ID Numbers: AkP 010112A
Study First Received: July 19, 2012
Last Updated: July 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
rhinitis
stuffy nose
congestion
Sneezing

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
 Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013