Allergic RhinitisPhase 2/3NCT00791102
Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)
A Phase 2/3 study testing ASP-1001 nasal spray in people with Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen. Read more about this study
- Who is it for?
- Ages 18 days to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- ASP-1001 nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 days to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males and females between 18 and 55 years of age.
- History of grass and/or ragweed allergic rhinitis.
- Positive skin test to grass and/or ragweed antigen.
- Positive response to screening nasal challenge.
Who cannot join
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection or sinusitis within 14 days of study start.
- Use of nasal steroids, antihistamines in the last 2 weeks.
- FEV1<80% of predicted at screening for subjects with history of mild asthma
- current smokers or recent ex-smokers
- Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical ASP-1001 (Contrast Media Formulation) in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (NAC)
The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.
- Conditions
- Allergic Rhinitis
- Being tested
- ASP-1001 nasal spray, Placebo for ASP-1001
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP-1001 nasal sprayDrug
2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Placebo for ASP-1001Drug
2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Topical ASP-1001 Receives: Drug: ASP-1001 nasal spray |
| 2 | Placebo comparator | Placebo for Topical ASP-1001 Receives: Drug: Placebo for ASP-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sneezing Symptom
Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.
Measured: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Change in Runny Nose Symptom
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.
Measured: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Change in Stuffy Nose Symptom
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.
Measured: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Change in Itching Symptom
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.
Measured: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Secondary outcomes (2)
Nasal Peak Inspiratory Flow Measurements
The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.
Measured: 15 minutes after diluent challenge and 15 minutes after each antigen challenge
Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment
Measured: 15 minutes prior to treatment and 15 minutes post antigen challenges
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Asphelia Pharmaceuticals
- Responsible party
- Principal investigator, Robert Naclerio, University of Chicago
- Investigators
- Robert Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791102
- Sponsor's protocol ID
- 16504B (ASP2002-AR-01)
- Status last verified
- Jul 2013
- First submitted
- 13 Nov 2008
- Last updated
- 10 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical ASP-1001 (Contrast Media Formulation) in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (NAC)
- ClinicalTrials.gov ID
- NCT00791102
- Acronym / sponsor ID
- 16504B (ASP2002-AR-01)
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Asphelia Pharmaceuticals
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Posted 10 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ASP-1001 nasal sprayTopical ASP-1001 |
| 2 | Placebo comparator | Drug: Placebo for ASP-1001Placebo for Topical ASP-1001 |
Who may qualify
- Ages
- 18 days to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Males and females between 18 and 55 years of age.
- History of grass and/or ragweed allergic rhinitis.
- Positive skin test to grass and/or ragweed antigen.
- Positive response to screening nasal challenge.
Key exclusion criteria (7 listed)
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection or sinusitis within 14 days of study start.
- Use of nasal steroids, antihistamines in the last 2 weeks.
- FEV1<80% of predicted at screening for subjects with history of mild asthma
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 |
|---|---|---|
| ASP-1001 nasal spray2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge. | Drug | 1 |
| Placebo for ASP-10012 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge. | Drug | 2 |
Primary outcome
Change in Sneezing Symptom
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.
Change in Runny Nose Symptom
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.
Change in Stuffy Nose Symptom
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.
Change in Itching Symptom
Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.
2 secondary outcomes
Nasal Peak Inspiratory Flow Measurements
Time frame: 15 minutes after diluent challenge and 15 minutes after each antigen challenge
Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment
Time frame: 15 minutes prior to treatment and 15 minutes post antigen challenges
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Naclerio, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ASP-1001 nasal spray in people with Allergic Rhinitis, run by University of Chicago 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 4 inclusion and 7 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 10 Jul 2013. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Sneezing Symptom (time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge). The study lists 4 primary outcomes in all. 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 10 Jul 2013.