Allergic RhinitisPhase 1/2SCITNCT01878929
The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions
A Phase 1/2 study testing Allergen(Tree, Grass, Weeds) in people with Allergic Rhinitis and Asthma, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which a patient receives frequent, escalating doses of the allergens they are allergic to until they reach a predetermined maintenance dose. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis, Asthma, Allergic Conjunctivitis
- What is being tested?
- Allergen(Tree, Grass, Weeds)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2014
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- include individuals ages 5 and greater at Allergy/Immunology Associates, Inc., who are receiving build-up SCIT to tree, grass, and/or weed pollens for allergic rhinitis, allergic conjunctivitis, and/or asthma
Who cannot join
- are in maintenance phase of SCIT
- are on beta-blockers
- have a forced expiratory volume in 1 second (FEV1) of less than 70% of predicted
- have a history of anaphylaxis with previous SCIT to aeroallergens (as defined by the requirement of intramuscular or subcutaneous epinephrine for treatment of a SCIT-induced reaction)
- have any uncontrolled cardiac or pulmonary disease as determined by their treating allergist/immunologist
- are pregnant, due to risk of harm to fetus if anaphylaxis occurs.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Allergy/Immunology Associates Inc.
South Euclid, Ohio, 44121
Haig Tcheurekdjian, M.D., 216-381-3333, haig.tcheurekdjian@gmail.com
Devi Jhaveri, D.O., 2163813333, devi.jhaveri@uhhospitals.org
About this study
Official title: The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions: A Double Blind Randomized Control Trial.
Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which a patient receives frequent, escalating doses of the allergens they are allergic to until they reach a predetermined maintenance dose. This is followed by a maintenance phase during which the allergen dose is kept constant and administered at greater intervals. Maximum clinical improvement is generally not seen until a patient is in the maintenance phase. Anecdotal evidence of possible reactions to SCIT administered during a patient's pollen season has led to dosage freezes during a patient's pollen season which extends the length of the build-up phase by many months. Prolonging the buildup phase increases the time required to obtain maximal benefit from SCIT, and at the same time, can decrease patient compliance with therapy due to the prolonged period of time when frequent injections are required.
The aims of this study are to determine if adverse reactions to pollen SCIT are increased if doses are increased during pollen season.
Read the detailed description
Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which a patient receives frequent, escalating doses of the allergens they are allergic to until they reach a predetermined maintenance dose. This is followed by a maintenance phase during which the allergen dose is kept constant and administered at greater intervals. Maximum clinical improvement is generally not seen until a patient is in the maintenance phase. Anecdotal evidence of possible reactions to SCIT administered during a patient's pollen season has led to dosage freezes during a patient's pollen season which extends the length of the build-up phase by many months. Prolonging the buildup phase increases the time required to obtain maximal benefit from SCIT, and at the same time, can decrease patient compliance with therapy due to the prolonged period of time when frequent injections are required.
The aims of this study are to determine if adverse reactions to pollen SCIT are increased if doses are increased during pollen season.
Specific Aim 1: To determine if escalating pollen SCIT doses during the pollen season is associated with an increased rate of immediate reactions in comparison to holding SCIT doses constant.
Hypothesis: There will not be an increased rate of immediate reactions to SCIT in build up phase received during the pollen season in comparison to SCIT held for pollen season.
Strategy: In a prospective trial, 245 subjects will be randomized to receive monthly (doses held constant) or weekly (doses built up) injections. Rate of immediate local and systemic reactions per injection will be compared between the two groups.
Specific Aim 2: To determine if escalating pollen SCIT doses during the pollen season is associated with an increased rate of delayed reactions in comparison to holding SCIT doses constant.
Hypothesis: There will not be an increased rate of delayed reactions to SCIT in build up phase received during the pollen season in comparison to SCIT held for pollen season.
Strategy: In a prospective trial, 245 subjects will be randomized to receive monthly (doses held constant) or weekly (doses built up) injections. Rate of delayed reactions per injection will be compared between the two groups.
BACKGROUND AND SIGNIFICANCE
Immunotherapy is one of the most effective therapies for allergic rhinoconjunctivitis, but the protocol dosing during pollen season is based on limited data. Immunotherapy is given in increasing dosage during the build up phase in order to build tolerance. After the build up phase, there is a maintenance phase that is used for the remainder of therapy. At this time, there is little data to support the common practice of not increasing the dosage of immunotherapy during pollen seasons.
The recent allergen immunotherapy practice parameter references 2 articles that have noted no increased systemic reactions to SCIT during pollen season. , In one prospective study, it was concluded that there was no direct correlation of reactions to SCIT and pollen season.3 They did note a correlation between the mean monthly mold counts in August to October and the rate of systemic reactions. The other study referenced is a prospective study which did not observe a statistically significant difference in the rate of systemic reactions to grass or ragweed pollen during their respective pollen seasons.4 However, the conclusions of these studies are conflicted by another study which consists of surveys retrospectively sent to members of the American Academy of Allergy Asthma and Immunology. The surveys in this study identified 46% of near fatal reactions to SCIT as occurring during peak allergy season. Though the immunotherapy standard parameters are not defining pollen season as a contraindication, we will consider it more that minimal risk for this study.
It is still common practice to stop the buildup phase and not escalate SCIT dosing during pollen season due to the conflicting available data and limitations in study design of many of the studies (retrospective, questionnaire based). A further look into SCIT dosing during pollen season will allow for more standardized practice and potentially improved patient outcomes.
- Conditions
- Allergic Rhinitis, Asthma, Allergic Conjunctivitis
- Being tested
- Allergen(Tree, Grass, Weeds)
- Keywords
- pollen, allergen immunotherapy, subcutaneous allergen immunotherapy, SCIT
- Medical subject headings
- Rhinitis, Allergic, Asthma, Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen(Tree, Grass, Weeds)Drug
Also called "Greer Grass Extract", "Greer Tree Extract", "Greer Ragweed Extract", "Greer Weed Extract"
Greer is manufacture of all allergen extract used in this study.
| Study group | Role | What they receive |
|---|---|---|
| Allergen(Tree, Grass, Weeds) -Held | Active comparator | Allergen(Tree, Grass, Weeds)-Held
Weekly administration of Greer manufactured allergen extract at same dose and concentration patient was on prior to allergen season for the duration of patients allergen season. Receives: Drug: Allergen(Tree, Grass, Weeds) |
| Allergen(Tree, Grass, Weeds) -Build-up | Active comparator | Allergen(Tree, Grass, Weeds) -Build-up
Weekly administration of Greer manufactured allergen extract at escalating dose and concentration patient for the duration of patients allergen season. Receives: Drug: Allergen(Tree, Grass, Weeds) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Reaction Rate of Build-Up Phase in Pollen Season
To determine if escalating pollen SCIT doses during the pollen season is associated with an increased rate of immediate reactions in comparison to holding SCIT doses constant.
Measured: 1 year
Secondary outcomes (1)
Delayed Reaction Rate of Build-Up Phase during Pollen Season
To determine if escalating pollen SCIT doses during the pollen season is associated with an increased rate of delayed reactions in comparison to holding SCIT doses constant.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
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.
- More trials run by University Hospitals Cleveland Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devi Jhaveri, University Hospitals Cleveland Medical Center
- Investigators
- Devi K Jhaveri, D.O., Principal investigator, University Hospitals Cleveland Medical CenterHaig Tcheurekdjian, M.D., Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878929
- Sponsor's protocol ID
- 02-13-06
- Acronym
- SCIT
- Status last verified
- Jun 2013
- First submitted
- 28 May 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions: A Double Blind Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT01878929
- Acronym / sponsor ID
- SCIT / 02-13-06
- Conditions
- Allergic Rhinitis, Asthma, Allergic Conjunctivitis
- Keywords
- pollen, allergen immunotherapy, subcutaneous allergen immunotherapy, SCIT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 17 Jun 2013 (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.
Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which a patient receives frequent, escalating doses of the allergens they are allergic to until they reach a predetermined maintenance dose. This is followed by a maintenance phase during which the allergen dose is kept constant and administered at greater intervals. Maximum clinical improvement is generally not seen until a patient is in the maintenance phase. Anecdotal evidence of possible reactions to SCIT administered during a patient's pollen season has led to dosage freezes during a patient's pollen season which extends the length of the build-up phase by many months. Prolonging the buildup phase increases the time required to obtain maximal benefit from SCIT, and at the same time, can decrease patient compliance with therapy due to the prolonged period of time when frequent injections are required.
The aims of this study are to determine if adverse reactions to pollen SCIT are increased if doses are increased during pollen season.
Detailed description
Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which a patient receives frequent, escalating doses of the allergens they are allergic to until they reach a predetermined maintenance dose. This is followed by a maintenance phase during which the allergen dose is kept constant and administered at greater intervals. Maximum clinical improvement is generally not seen until a patient is in the maintenance phase. Anecdotal evidence of possible reactions to SCIT administered during a patient's pollen season has led to dosage freezes during a patient's pollen season which extends the length of the build-up phase by many months. Prolonging the buildup phase increases the time required to obtain maximal benefit from SCIT, and at the same time, can decrease patient compliance with therapy due to the prolonged period of time when frequent injections are required.
The aims of this study are to determine if adverse reactions to pollen SCIT are increased if doses are increased during pollen season.
Specific Aim 1: To determine if escalating pollen SCIT doses during the pollen season is associated with an increased rate of immediate reactions in comparison to holding SCIT doses constant.
Hypothesis: There will not be an increased rate of immediate reactions to SCIT in build up phase received during the pollen season in comparison to SCIT held for pollen season.
Strategy: In a prospective trial, 245 subjects will be randomized to receive monthly (doses held constant) or weekly (doses built up) injections. Rate of immediate local and systemic reactions per injection will be compared between the two groups.
Specific Aim 2: To determine if escalating pollen SCIT doses during the pollen season is associated with an increased rate of delayed reactions in comparison to holding SCIT doses constant.
Hypothesis: There will not be an increased rate of delayed reactions to SCIT in build up phase received during the pollen season in comparison to SCIT held for pollen season.
Strategy: In a prospective trial, 245 subjects will be randomized to receive monthly (doses held constant) or weekly (doses built up) injections. Rate of delayed reactions per injection will be compared between the two groups.
BACKGROUND AND SIGNIFICANCE
Immunotherapy is one of the most effective therapies for allergic rhinoconjunctivitis, but the protocol dosing during pollen season is based on limited data. Immunotherapy is given in increasing dosage during the build up phase in order to build tolerance. After the build up phase, there is a maintenance phase that is used for the remainder of therapy. At this time, there is little data to support the common practice of not increasing the dosage of immunotherapy during pollen seasons.
The recent allergen immunotherapy practice parameter references 2 articles that have noted no increased systemic reactions to SCIT during pollen season. , In one prospective study, it was concluded that there was no direct correlation of reactions to SCIT and pollen season.3 They did note a correlation between the mean monthly mold counts in August to October and the rate of systemic reactions. The other study referenced is a prospective study which did not observe a statistically significant difference in the rate of systemic reactions to grass or ragweed pollen during their respective pollen seasons.4 However, the conclusions of these studies are conflicted by another study which consists of surveys retrospectively sent to members of the American Academy of Allergy Asthma and Immunology. The surveys in this study identified 46% of near fatal reactions to SCIT as occurring during peak allergy season. Though the immunotherapy standard parameters are not defining pollen season as a contraindication, we will consider it more that minimal risk for this study.
It is still common practice to stop the buildup phase and not escalate SCIT dosing during pollen season due to the conflicting available data and limitations in study design of many of the studies (retrospective, questionnaire based). A further look into SCIT dosing during pollen season will allow for more standardized practice and potentially improved patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergen(Tree, Grass, Weeds) -Held | Active comparator | Drug: Allergen(Tree, Grass, Weeds)Allergen(Tree, Grass, Weeds)-Held Weekly administration of Greer manufactured allergen extract at same dose and concentration patient was on prior to allergen season for the duration of patients allergen season. |
| Allergen(Tree, Grass, Weeds) -Build-up | Active comparator | Drug: Allergen(Tree, Grass, Weeds)Allergen(Tree, Grass, Weeds) -Build-up Weekly administration of Greer manufactured allergen extract at escalating dose and concentration patient for the duration of patients allergen season. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- include individuals ages 5 and greater at Allergy/Immunology Associates, Inc., who are receiving build-up SCIT to tree, grass, and/or weed pollens for allergic rhinitis, allergic conjunctivitis, and/or asthma
Key exclusion criteria (6 listed)
- are in maintenance phase of SCIT
- are on beta-blockers
- have a forced expiratory volume in 1 second (FEV1) of less than 70% of predicted
- have a history of anaphylaxis with previous SCIT to aeroallergens (as defined by the requirement of intramuscular or subcutaneous epinephrine for treatment of a SCIT-induced reaction)
- have any uncontrolled cardiac or pulmonary disease as determined by their treating allergist/immunologist
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 |
|---|---|---|
| Allergen(Tree, Grass, Weeds)Also: "Greer Grass Extract", "Greer Tree Extract", "Greer Ragweed Extract", "Greer Weed Extract"Greer is manufacture of all allergen extract used in this study. | Drug | Allergen(Tree, Grass, Weeds) -Build-up, Allergen(Tree, Grass, Weeds) -Held |
Primary outcome
Immediate Reaction Rate of Build-Up Phase in Pollen Season
Time frame: 1 year
To determine if escalating pollen SCIT doses during the pollen season is associated with an increased rate of immediate reactions in comparison to holding SCIT doses constant.
1 secondary outcome
Delayed Reaction Rate of Build-Up Phase during Pollen Season
Time frame: 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
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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.
Devi K Jhaveri, D.O. principal investigator
University Hospitals Cleveland Medical Center
Haig Tcheurekdjian, M.D. principal investigator
University Hospitals Cleveland Medical Center
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 Allergen(Tree, Grass, Weeds) in people with Allergic Rhinitis and Asthma, run by University Hospitals Cleveland Medical Center 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Jun 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Devi K Jhaveri, D.O. (2163813333, devi.jhaveri@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Reaction Rate of Build-Up Phase in Pollen Season (time frame: 1 year). 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 17 Jun 2013.