Allergic RhinitisPhase 1/2NCT01647633
Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash
A Phase 1/2 study testing Calcium Glycerophosphate Nasal Spray Wash in people with Allergic Rhinitis, run by Drexel University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Calcium Glycerophosphate Nasal Spray Wash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to May 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
About this study
Official title: 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.
Read the 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.
- Conditions
- Allergic Rhinitis
- Being tested
- Calcium Glycerophosphate Nasal Spray Wash
- Keywords
- rhinitis, stuffy nose, congestion, Sneezing
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Nasal Obstruction, Sneezing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Glycerophosphate Nasal Spray WashOther
Nasal wash two to six times per day
| Study group | Role | What they receive |
|---|---|---|
| Calcium Glycerophosphate Nasal Wash | Experimental | Nasal spray wash twice daily and up to four additional times per day as needed for nasal allergy symptoms Receives: Other: Calcium Glycerophosphate Nasal Spray Wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Symptom Diary
Perceived improved comfort breathing is anticipated as primary outcome
Measured: 28 days
Secondary outcomes (1)
Spirometry
Anticipate change in spirometry
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- AkPharma Inc.
- Responsible party
- Principal investigator, Edward Schulman, Drexel University
- Investigators
- Edward S Schulman, MD, Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647633
- Sponsor's protocol ID
- AkP 010112A
- Status last verified
- May 2015
- First submitted
- 19 Jul 2012
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash on Patient-Perceived Breathing Comfort
- ClinicalTrials.gov ID
- NCT01647633
- Acronym / sponsor ID
- AkP 010112A
- Conditions
- Allergic Rhinitis
- Keywords
- rhinitis, stuffy nose, congestion, Sneezing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- AkPharma Inc.
- Study start
- May 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcium Glycerophosphate Nasal Wash | Experimental | Other: Calcium Glycerophosphate Nasal Spray WashNasal spray wash twice daily and up to four additional times per day as needed for nasal allergy symptoms |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Glycerophosphate Nasal Spray WashNasal wash two to six times per day | Other | Calcium Glycerophosphate Nasal Wash |
Primary outcome
Nasal Symptom Diary
Time frame: 28 days
Perceived improved comfort breathing is anticipated as primary outcome
1 secondary outcome
Spirometry
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward S Schulman, MD principal investigator
Drexel University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Calcium Glycerophosphate Nasal Spray Wash in people with Allergic Rhinitis, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Symptom Diary (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2015.