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Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01647633
Recruitment Status : Completed
First Posted : July 23, 2012
Last Update Posted : May 25, 2015
Sponsor:
Collaborator:
AkPharma Inc.
Information provided by (Responsible Party):
Edward Schulman, Drexel University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Other: Calcium Glycerophosphate Nasal Spray Wash Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash on Patient-Perceived Breathing Comfort
Study Start Date : May 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Nasal Symptom Diary [ Time Frame: 28 days ]
    Perceived improved comfort breathing is anticipated as primary outcome


Secondary Outcome Measures :
  1. Spirometry [ Time Frame: 21 days ]
    Anticipate change in spirometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647633


Locations
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United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University
AkPharma Inc.
Investigators
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Principal Investigator: Edward S Schulman, MD Drexel University College of Medicine
More Information
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Responsible Party: Edward Schulman, MD, PI, Drexel University
ClinicalTrials.gov Identifier: NCT01647633    
Other Study ID Numbers: AkP 010112A
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2015
Keywords provided by Edward Schulman, Drexel University:
rhinitis
stuffy nose
congestion
Sneezing
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs