Seasonal Allergic RhinitisPhase 1/2NCT02377895
Allergen Biocube Study Evaluating Efficacy and Safety of Nasapaque Nasal Solution in Adult Subjects With Allergic Rhinitis
A Phase 1/2 study testing Nasapaque Nasal Solution in people with Seasonal Allergic Rhinitis, run by 3E Therapeutics Corporation.
Trial summary
Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Nasapaque Nasal Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years of age and provide written informed consent and sign the HIPAA form
- Must have history of allergic rhinitis
- Must have positive response to Allergen BioCube
Who cannot join
- Must not have a significant illness such as moderate to severe allergic asthmatic reactions
- Must not have compromised lung function
- Must not use any disallowed medications
- Must not have been in an investigational study in the last 30 days
About this study
Official title: A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Parallel-Group Allergen BioCube Study Evaluating the Efficacy and Safety of Nasapaque Nasal Solution in a Population of Adult Subjects With Seasonal Allergic Rhinitis
Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Nasapaque Nasal Solution, Placebo Saline Nasal Solution
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasapaque Nasal SolutionDrug
Placebo Saline Nasal SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Nasapaque Nasal Solution | Experimental | 250 ul in each nostril at Day 1 and Day 8 Receives: Drug: Nasapaque Nasal Solution |
| Placebo Saline Nasal Solution | Active comparator | 250 ul in each nostril at Day 1 and Day 8 Receives: Drug: Placebo Saline Nasal Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNSS Total Nasal Symptom Score
Measured: Day 1 and Day 8
Secondary outcomes (2)
Nasal Inspiratory Flow
Measured: Day 1 and Day 8
Nasal Inflammation Score
Measured: Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3E Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377895
- Sponsor's protocol ID
- 14-100-0008
- Status last verified
- Jan 2017
- First submitted
- 27 Feb 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gomes PJ, Abelson MB, Stein L, Viirre E, Villafranca JE, Lasser EC. Iodixanol nasal solution reduces allergic rhinoconjunctivitis signs and symptoms in Allergen BioCube(R): a randomized clinical trial. J Asthma Allergy. 2019 Mar 1;12:71-81. doi: 10.2147/JAA.S150251. eCollection 2019.
PubMed 30881050
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Parallel-Group Allergen BioCube Study Evaluating the Efficacy and Safety of Nasapaque Nasal Solution in a Population of Adult Subjects With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02377895
- Acronym / sponsor ID
- 14-100-0008
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- 3E Therapeutics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Mar 2015 (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.
Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasapaque Nasal Solution | Experimental | Drug: Nasapaque Nasal Solution250 ul in each nostril at Day 1 and Day 8 |
| Placebo Saline Nasal Solution | Active comparator | Drug: Placebo Saline Nasal Solution250 ul in each nostril at Day 1 and Day 8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be 18 years of age and provide written informed consent and sign the HIPAA form
- Must have history of allergic rhinitis
- Must have positive response to Allergen BioCube
Key exclusion criteria (4 listed)
- Must not have a significant illness such as moderate to severe allergic asthmatic reactions
- Must not have compromised lung function
- Must not use any disallowed medications
- Must not have been in an investigational study in the last 30 days
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 |
|---|---|---|
| Nasapaque Nasal Solution | Drug | Nasapaque Nasal Solution |
| Placebo Saline Nasal Solution | Drug | Placebo Saline Nasal Solution |
Primary outcome
TNSS Total Nasal Symptom Score
Time frame: Day 1 and Day 8
2 secondary outcomes
Nasal Inspiratory Flow
Time frame: Day 1 and Day 8
Nasal Inflammation Score
Time frame: Day 1 and Day 8
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 26 Jan 2017.
- Derived from this study: PubMed 30881050Gomes PJ, Abelson MB, Stein L, Viirre E, Villafranca JE, Lasser EC. Iodixanol nasal solution reduces allergic rhinoconjunctivitis signs and symptoms in Allergen BioCube(R): a randomized clinical trial. J Asthma Allergy. 2019 Mar 1;12:71-81. doi: 10.2147/JAA.S150251. eCollection 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nasapaque Nasal Solution in people with Seasonal Allergic Rhinitis, run by 3E Therapeutics Corporation.
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 4 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
TNSS Total Nasal Symptom Score (time frame: Day 1 and Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377895, which also lists 1 linked publication.
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 26 Jan 2017.