Seasonal Allergic RhinitisPhase 1NCT01280149
Reduction of IgE Antibody in Human Allergic Subjects
A Phase 1 study testing substance P and substance P injections in people with Seasonal Allergic Rhinitis, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a neuropeptide, substance P, when injected along with an allergen, such as ragweed, can reduce allergic reactivity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- substance P and substance P injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 20 Jun 2017
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- positive immediate type skin test to ragweed or grass pollen or a third (standardized) allergen if both ragweed and grass pollen allergen are not positive
- volunteers should be available for allergen injections and then cutaneous titrations for approximately 1 year from the start of the enrollment period
Who cannot join
- volunteer is pregnant or lactating
- abnormal electrocardiogram for subjects over 50 years of age
- use of beta adrenergic antagonists or tricyclic antidepressants
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
The purpose of this study is to determine whether a neuropeptide, substance P, when injected along with an allergen, such as ragweed, can reduce allergic reactivity.
Read the detailed description
Allergic Rhinitis (Hay fever) affects many children and adults and is a risk factor for development of asthma. This study utilizes the neurotransmitter, substance P, a small molecule which is present in nerve endings, the brain, skin, lungs and the gastrointestinal tract. Subjects will receive substance P and a low dosage of an allergen, such as ragweed in an attempt to reduce allergic reactivity.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- substance P, substance P injections
- Keywords
- substance P, allergic rhinitis, allergen immunotherapy
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
substance PBiological
injections of substance P and low dose allergen or placebo
substance P injectionsBiological
injections of substance P for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| substance P-low dose allergen | Experimental | Substance P injections with 8 sequential, increasing doses of allergen Receives: Biological: substance P; Biological: substance P injections |
| substance P-moderate dose allergen | Experimental | Substance P with sequential, increasing doses of allergen Receives: Biological: substance P; Biological: substance P injections |
| substance P-low/moderate dose allergen | Experimental | substance P with 16 sequential increasing doses of allergen Receives: Biological: substance P; Biological: substance P injections |
| substance P-placebo | Active comparator | Placebo injections of substance P and placebo Receives: Biological: substance P; Biological: substance P injections |
| placebo-low dose allergen | Experimental | Placebo injections with 8 sequential increasing low dose allergen injections Receives: Biological: substance P; Biological: substance P injections |
| placebo-placebo | Placebo comparator | substance P placebo and allergen placebo (weekly) Receives: Biological: substance P; Biological: substance P injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBER ID50 skin test result
The ID50 skin test result utilizes FDA CBER methodology to determine the change in allergic skin reactivity to ragweed and grass pollen allergens.
Measured: 1 to 6 months after completing injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startJan 2011
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Greenberger, Northwestern University
- Investigators
- Paul A Greenberger, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280149
- Sponsor's protocol ID
- BB-IND 4458
- Status last verified
- Aug 2018
- First submitted
- 18 Jan 2011
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of IgE Antibody in Human Allergic Subjects
- ClinicalTrials.gov ID
- NCT01280149
- Acronym / sponsor ID
- BB-IND 4458
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- substance P, allergic rhinitis, allergen immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 20 Jan 2011 (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.
The purpose of this study is to determine whether a neuropeptide, substance P, when injected along with an allergen, such as ragweed, can reduce allergic reactivity.
Detailed description
Allergic Rhinitis (Hay fever) affects many children and adults and is a risk factor for development of asthma. This study utilizes the neurotransmitter, substance P, a small molecule which is present in nerve endings, the brain, skin, lungs and the gastrointestinal tract. Subjects will receive substance P and a low dosage of an allergen, such as ragweed in an attempt to reduce allergic reactivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| substance P-low dose allergen | Experimental | Biological: substance P, Biological: substance P injectionsSubstance P injections with 8 sequential, increasing doses of allergen |
| substance P-moderate dose allergen | Experimental | Biological: substance P, Biological: substance P injectionsSubstance P with sequential, increasing doses of allergen |
| substance P-low/moderate dose allergen | Experimental | Biological: substance P, Biological: substance P injectionssubstance P with 16 sequential increasing doses of allergen |
| substance P-placebo | Active comparator | Biological: substance P, Biological: substance P injectionsPlacebo injections of substance P and placebo |
| placebo-low dose allergen | Experimental | Biological: substance P, Biological: substance P injectionsPlacebo injections with 8 sequential increasing low dose allergen injections |
| placebo-placebo | Placebo comparator | Biological: substance P, Biological: substance P injectionssubstance P placebo and allergen placebo (weekly) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- positive immediate type skin test to ragweed or grass pollen or a third (standardized) allergen if both ragweed and grass pollen allergen are not positive
- volunteers should be available for allergen injections and then cutaneous titrations for approximately 1 year from the start of the enrollment period
Key exclusion criteria (3 listed)
- volunteer is pregnant or lactating
- abnormal electrocardiogram for subjects over 50 years of age
- use of beta adrenergic antagonists or tricyclic antidepressants
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 |
|---|---|---|
| substance Pinjections of substance P and low dose allergen or placebo | Biological | placebo-low dose allergen, placebo-placebo, substance P-low dose allergen, substance P-low/moderate dose allergen, substance P-moderate dose allergen, substance P-placebo |
| substance P injectionsinjections of substance P for 8 weeks | Biological | placebo-low dose allergen, placebo-placebo, substance P-low dose allergen, substance P-low/moderate dose allergen, substance P-moderate dose allergen, substance P-placebo |
Primary outcome
CBER ID50 skin test result
Time frame: 1 to 6 months after completing injections
The ID50 skin test result utilizes FDA CBER methodology to determine the change in allergic skin reactivity to ragweed and grass pollen allergens.
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 21 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Seasonal Allergic Rhinitis
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
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.
Paul A Greenberger, M.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing substance P and substance P injections in people with Seasonal Allergic Rhinitis, run by Northwestern 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 2 inclusion and 3 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 21 Aug 2018. 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 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.
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?
CBER ID50 skin test result (time frame: 1 to 6 months after completing injections). 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 21 Aug 2018.