Clinical trial NCT01647633: Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash
Official title: Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash on Patient-Perceived Breathing Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Allergic Rhinitis
Keywords: rhinitis
stuffy nose
congestion
Sneezing
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: AkPharma Inc.
First posted: 2012-07-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Nasal Symptom Diary
timeFrame: 28 days
Secondary outcomes:
measure: Spirometry
timeFrame: 21 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Edward S Schulman, MD
role: PRINCIPAL_INVESTIGATOR
References: