Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
July 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 25, 2015
May 1, 2015
2.9 years
July 19, 2012
May 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nasal Symptom Diary
Perceived improved comfort breathing is anticipated as primary outcome
28 days
Secondary Outcomes (1)
Spirometry
21 days
Study Arms (1)
Calcium Glycerophosphate Nasal Wash
EXPERIMENTALNasal spray wash twice daily and up to four additional times per day as needed for nasal allergy symptoms
Interventions
Nasal wash two to six times per day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Drexel Universitylead
- AkPharma Inc.collaborator
Study Sites (1)
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward S Schulman, MD
Drexel University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PI
Study Record Dates
First Submitted
July 19, 2012
First Posted
July 23, 2012
Study Start
May 1, 2012
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
May 25, 2015
Record last verified: 2015-05