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Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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: October 27, 2014
Last verified: October 2014

July 19, 2012
October 27, 2014
May 2012
April 2015   (final data collection date for primary outcome measure)
Nasal Symptom Diary [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Perceived improved comfort breathing is anticipated as primary outcome
Same as current
Complete list of historical versions of study NCT01647633 on ClinicalTrials.gov Archive Site
Spirometry [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Anticipate change in spirometry
Same as current
Not Provided
Not Provided
 
Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash
Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash on Patient-Perceived Breathing Comfort

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Allergic Rhinitis
Other: Calcium Glycerophosphate Nasal Spray Wash
Nasal wash two to six times per day
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact: Mary P Hendry, MS, RN 215 762 7499 mhendry@drexelmed.edu
Contact: Edward S Schulman, MD 215 762 7013 eschulma@drexelmed.edu
United States
 
NCT01647633
AkP 010112A
No
Edward Schulman, Drexel University
Drexel University
AkPharma Inc.
Principal Investigator: Edward S Schulman, MD Drexel University College of Medicine
Drexel University
October 2014

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