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Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

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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

Tracking Information
First Submitted Date  ICMJE July 19, 2012
First Posted Date  ICMJE July 23, 2012
Last Update Posted Date May 25, 2015
Study Start Date  ICMJE May 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2012)
Nasal Symptom Diary [ Time Frame: 28 days ]
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
 (submitted: July 20, 2012)
Spirometry [ Time Frame: 21 days ]
Anticipate change in spirometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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 Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2015)
17
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2012)
40
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date April 2015   (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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01647633
Other Study ID Numbers  ICMJE AkP 010112A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account Drexel University
Verification Date May 2015

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