Allergic RhinitisPhase 3NCT00599872
Efficacy Study of Sublingual Immunotherapy to Treat Ragweed Allergies
A Phase 3 study testing Standardized Ragweed Allergenic Extract in people with Allergic Rhinitis, run by Greer Laboratories at 30 sites in United States.
Trial summary
The purpose of this study is to determine an effective dose range for the administration of ragweed allergenic extract via the sublingual route of administration Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Standardized Ragweed Allergenic Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 30 sitesUnited States
- Study dates
- Mar 2008to Dec 2008
- Phase
- Phase 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult ragweed-sensitive Subjects with allergic rhinoconjunctivitis with or without asthma during ragweed pollen season.
- Subjects must be 18 to 50 years of age.
- Test Subjects will have a history of moderate to severe isolated or unseasonal allergic rhinoconjunctivitis with or without mild intermittent asthma symptoms attributable to ragweed pollen for a minimum of 2 years before study entry.
- Subjects with or with out a history of asthma will possess FEV1 and PEF greater than or equal to 80% predicted at the beginning of the study established by spirometry and defined by the Knudson predicted set.
- Sensitivity to the relevant allergen will be documented by a positive skin prick test result performed along with negative (saline) and positive (histamine) control skin tests. A positive test will be defined as the skin reaction having the longest wheal diameter of 5mm or greater or the longest erythema diameter of 10 mm or greater at 15-20 minutes after application.
- All female Subjects of child-bearing potential will be required to provide a urine sample for pregnancy testing that must be negative before being allowed to participate in the study.
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- Subjects must be planning to remain in the study area during the trial (see exclusion criteria # 14).
- Subjects must be trained on the proper use of the EpiPen, and sign the EpiPenTraining Form before being allowed to enroll in the study.
- Subjects must be mentally and physically capable of self-administering oral drug.
Who cannot join
- Subjects having a history of anaphylaxis or history consistent with persistent asthma
- Subjects taking antihistamines or nasal steroids medications greater than twice a week in the months of January and/or February.
- Subjects with chronic sinusitis unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the test drug or pose additional risk to the Subject.
- Subjects having perennial or structurally related rhinitis or rhinitis medicamentosa (from excessive use of nasal decongestants) that will interfere with the evaluation of symptoms due to ragweed allergy.
- Subjects with an FEV1 or PEF less than 80% predicted (moderate persistent asthma) with or without controller medication.
- Subjects who have received an experimental drug in the 30 days prior to admission into this study or who plan to use an experimental drug during the study.
Show all 17Show fewer
- Subjects who have received Anti-IgE medications (Xolair) or similar compounds in the last 12 months.
- Subjects who have received ragweed allergen immunotherapy in the last 3 years prior to admission into this study.
- Subjects who are current users of inhaled, oral, intramuscular, intravenous corticosteroids, tricyclic antidepressants, beta blockers, or MAO inhibitors.
- Subjects using beta-agonist more than twice a month unless being taken prior to exercise.
- Subjects using medications that could induce adverse gastrointestinal reactions during the study. Subjects using such medications must prove stable with no side effects for at least 3 months prior to enrollment.
- Subjects refusing to sign the EpiPen Training Form will be excluded from the study.
- Pregnant or breast feeding females.
- Subjects who plan to leave the study area for more than 2 consecutive weeks during the study.
- Subjects with a positive skin prick test to cat and/or dog, and own the pet(s) to which they are allergic.
- Subjects who sleep during the day due to working third shift.
- Subjects unable to achieve dose #2 or higher during preliminary dosing will be excluded.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Valley Clinical Research Center
Bethlehem, Pennsylvania, 18020
Allergy and Asthma Specialists, PC
Blue Bell, Pennsylvania, 19422
Ocean Allergy and Respiratory Research Center
Brick, New Jersey, 08724
Allergy and Respiratory Center
Canton, Ohio, 44718
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
Cleveland Clinic
Cleveland, Ohio, 44195
Pharmaceutical Research & Consulting, Inc
Dallas, Texas, 75231
Welborn Clinic
Evansville, Indiana, 47713
Allergy, Asthma and Sinus Center, SC
Greenfield, Wisconsin, 53228
Iowa Clinical Research Corporation
Iowa City, Iowa, 52240
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Asthma, Immunology and Allergy Association, LLC
Lincoln, Nebraska, 68505
Family Allergy and Asthma Respiratory Institute
Louisville, Kentucky, 40215
University of Wisconsin
Madison, Wisconsin, 53792
Aurora Advanced Healthcare, Inc
Milwaukee, Wisconsin, 53209
Clinical Research Institute
Minneapolis, Minnesota, 55402
Vanderbilt ASAP Research
Nashville, Tennessee, 08724
Sneeze, Wheeze, & Itch Associates
Normal, Illinois, 61761
Oklahoma Allergy & Asthma Clinic, PC
Oklahoma City, Oklahoma, 73104
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120
Midwest Allergy and Asthma Clinic, PA
Omaha, Nebraska, 68130
Creighton University
Omaha, Nebraska, 68131
College Park Family Care Center
Overland Park, Kansas, 66210
Kansas City Allergy and Asthma
Overland Park, Kansas, 66210
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Clinical Research of the Ozarks
Rolla, Missouri, 64501
Midwest Clinical Research, LLC
St Louis, Missouri, 63141
Pulmonary and Allergy Associates, PA
Summit, New Jersey, 07901
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Asthma and Allergy Research Associates
Upland, Pennsylvania, 19013
About this study
Official title: Parallel, Randomized, Double-Blind, Placebo-Controlled Trial in Adults for the Sublingual-Oral Immunotherapy (SLIT) of Allergic Rhinoconjunctivitis With or Without Asthma Caused By Ragweed Pollen
The purpose of this study is to determine an effective dose range for the administration of ragweed allergenic extract via the sublingual route of administration
Read the detailed description
Specific allergen immunotherapy as currently practiced in the USA and described in product labeling comprises the subcutaneous injection of incrementally increasing doses to a targeted maintenance dose ("build-up") followed by maintenance injections of allergenic extract/vaccine. Up to 30-40 injections may be required during the build-up phase over a 3-6 month period. When adequate maintenance doses are reached, this form of immunotherapy (SCIT) has been shown to be highly effective and safe.
Standard practices recommend that the injections be given under the supervision of trained physicians and that the patient remain in the physician's office at least 20 to 30 minutes after an injection. The administration of immunotherapy injections are not recommended at home because of the risk of inadequate recognition and treatment of systemic reactions. The inconvenience and expense of traveling for allergy injections and the discomfort of the repeated injections is a disincentive to this form of treatment particularly in pediatric patients. For example, dropout rates exceeding 50% over a multi-year course of injection treatment have been reported.
Alternative routes for immunotherapy have been explored, especially in Europe in an attempt to improve patient compliance and to minimize the risk of serious adverse reactions. For example, sublingual-oral immunotherapy (SLIT), which is the administration of the allergenic extract/vaccine under the tongue for 1-2 minutes followed by swallowing, has been proven to be efficacious and safe in several double-blind, placebo-controlled studies. A recent Cochrane Review concluded, "SLIT is a safe treatment, which significantly reduces symptoms and medication requirements in allergic rhinitis."
Efficacy studies support the use of SLIT for the treatment of rhinitis or rhinitis and asthma. However, dosage schedules are highly variable and optimal maintenance doses have not yet been established. Thus, dosing studies should be designed to investigate not only the safety profile but to determine optimal doses for maintenance therapy of patients built-up by injection IT and for build-up regimens of previously untreated patients.
Much of the United States medical community's hesitation to embrace sublingual immunotherapy as a viable treatment option for allergy patients has stemmed from limited information using U.S. licensed allergenic extracts for this treatment route. Additionally, the cost-effectiveness of one form of therapy over the other has not been clearly evaluated and the third-party payers have not accepted SLIT for insurance coverage.
- Conditions
- Allergic Rhinitis
- Being tested
- Standardized Ragweed Allergenic Extract, Placebo
- Keywords
- Allergy, Sublingual Immunotherapy, Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Ragweed Allergenic ExtractBiological
Standardized Ragweed Allergenic Extract, sublingual oral
PlaceboBiological
Placebo, sublingual oral
| Study group | Role | What they receive |
|---|---|---|
| Ragweed Allergenic Extract | Active comparator | Standardized Ragweed Allergenic Extract administered via the sublingual oral route (27.6 to 77.3 Amb a 1 Units) Receives: Biological: Standardized Ragweed Allergenic Extract |
| Placebo | Placebo comparator | Standardized Ragweed Allergenic Extract Placebo via the sublingual oral route Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on a Scale (Average of Daily Rhinoconjunctivitis Symptom Score (RSS) Recorded During the Ragweed Season
Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.
The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season.
Measured: Ragweed pollen season, 08/01/08 to 10/30/08, approximately 3 months
Secondary outcomes (5)
Scores on a Scale (Average Daily RSS During the Highest Pollen Count Week)
Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.
The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season.
The highest pollen count week was defined as the 7 contiguous days from the series with the largest average pollen count, and in which the weekly average was computed using at least 4 non-missing daily RSS values (either AM or PM could be present to be considered a valid daily RSS value).
Measured: 09/01/2008-09/07/2008
Scores on a Scale (Average Daily AM RSS and the Average Daily PM RSS During the Ragweed Season)
Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.
The average daily RSS (the sum of the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS).
Measured: Ragweed pollen season 08/01/08 to 10/30/08
Scores on a Scale (Average Daily RSS During the Ragweed Season for Each of the Three Organ) Systems (Ocular, Nasal, Ears);
The average daily RSS during the ragweed season for each of the 3 organ systems (ocular, nasal, ears) were separately analyzed to evaluate these individual components of the RSS. Three separate baseline average daily RSS values were computed for this analysis. The modified ITT population was used for this analysis. The range for scores: 0 to 3 for each of eight symptom or a total of 0 to 24 daily RSS. A lower score was more favorable.
Measured: Ragweed pollen season 08/01/08 to 10/30/08
Scores on a Scale (Total Allergy Relief Medication Score During the Ragweed Season) for Each Subject
Total allergy relief medication score during the ragweed season for each subject. This score is computed for each subject by summing their individual medication scores (excluding beta-agonist use) for the entire ragweed season. High scores were indicative of poor symptom relief from the study medication. The associated relief medication scores assigned to medication are 0-if no medication taken; 3 for each one antihistamine tablet taken; 1 for each 2 antihistamine eye drop administrations, 1 for each 2 antihistamine nasal spray administrations and 1 for each puff of beta-agonist. The maximum medication score was dependent on the cumulative rescue medication use. The lower result the more favorable.
Measured: Ragweed pollen season 08/01/08 to 10/30/08
Scores on a Scale (The Average Combined Allergy Symptom and Medication Score During the Ragweed Season for Each Subject)
The average combined allergy symptom and medication score during the ragweed season for each subject. This score is computed for each subject by adding their daily relief medication scores (excluding beta-agonist use) and their daily RSS for the entire ragweed season, and then taking the average of the combined scores across days.
Measured: Ragweed pollen season 08/01/08 to 10/30/08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2008
- Study completionDec 2008
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greer Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert E. Esch, PhD, Study director, Greer Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599872
- Sponsor's protocol ID
- SLIT07-01
- Status last verified
- Dec 2014
- First submitted
- 20 Dec 2007
- Last updated
- 14 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel, Randomized, Double-Blind, Placebo-Controlled Trial in Adults for the Sublingual-Oral Immunotherapy (SLIT) of Allergic Rhinoconjunctivitis With or Without Asthma Caused By Ragweed Pollen
- ClinicalTrials.gov ID
- NCT00599872
- Acronym / sponsor ID
- SLIT07-01
- Conditions
- Allergic Rhinitis
- Keywords
- Allergy, Sublingual Immunotherapy, Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Greer LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Posted 14 Jan 2015
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 an effective dose range for the administration of ragweed allergenic extract via the sublingual route of administration
Detailed description
Specific allergen immunotherapy as currently practiced in the USA and described in product labeling comprises the subcutaneous injection of incrementally increasing doses to a targeted maintenance dose ("build-up") followed by maintenance injections of allergenic extract/vaccine. Up to 30-40 injections may be required during the build-up phase over a 3-6 month period. When adequate maintenance doses are reached, this form of immunotherapy (SCIT) has been shown to be highly effective and safe.
Standard practices recommend that the injections be given under the supervision of trained physicians and that the patient remain in the physician's office at least 20 to 30 minutes after an injection. The administration of immunotherapy injections are not recommended at home because of the risk of inadequate recognition and treatment of systemic reactions. The inconvenience and expense of traveling for allergy injections and the discomfort of the repeated injections is a disincentive to this form of treatment particularly in pediatric patients. For example, dropout rates exceeding 50% over a multi-year course of injection treatment have been reported.
Alternative routes for immunotherapy have been explored, especially in Europe in an attempt to improve patient compliance and to minimize the risk of serious adverse reactions. For example, sublingual-oral immunotherapy (SLIT), which is the administration of the allergenic extract/vaccine under the tongue for 1-2 minutes followed by swallowing, has been proven to be efficacious and safe in several double-blind, placebo-controlled studies. A recent Cochrane Review concluded, "SLIT is a safe treatment, which significantly reduces symptoms and medication requirements in allergic rhinitis."
Efficacy studies support the use of SLIT for the treatment of rhinitis or rhinitis and asthma. However, dosage schedules are highly variable and optimal maintenance doses have not yet been established. Thus, dosing studies should be designed to investigate not only the safety profile but to determine optimal doses for maintenance therapy of patients built-up by injection IT and for build-up regimens of previously untreated patients.
Much of the United States medical community's hesitation to embrace sublingual immunotherapy as a viable treatment option for allergy patients has stemmed from limited information using U.S. licensed allergenic extracts for this treatment route. Additionally, the cost-effectiveness of one form of therapy over the other has not been clearly evaluated and the third-party payers have not accepted SLIT for insurance coverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ragweed Allergenic Extract | Active comparator | Biological: Standardized Ragweed Allergenic ExtractStandardized Ragweed Allergenic Extract administered via the sublingual oral route (27.6 to 77.3 Amb a 1 Units) |
| Placebo | Placebo comparator | Biological: PlaceboStandardized Ragweed Allergenic Extract Placebo via the sublingual oral route |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adult ragweed-sensitive Subjects with allergic rhinoconjunctivitis with or without asthma during ragweed pollen season.
- Subjects must be 18 to 50 years of age.
- Test Subjects will have a history of moderate to severe isolated or unseasonal allergic rhinoconjunctivitis with or without mild intermittent asthma symptoms attributable to ragweed pollen for a minimum of 2 years before study entry.
- Subjects with or with out a history of asthma will possess FEV1 and PEF greater than or equal to 80% predicted at the beginning of the study established by spirometry and defined by the Knudson predicted set.
- Sensitivity to the relevant allergen will be documented by a positive skin prick test result performed along with negative (saline) and positive (histamine) control skin tests. A positive test will be defined as the skin reaction having the longest wheal diameter of 5mm or greater or the longest erythema diameter of 10 mm or greater at 15-20 minutes after application.
Key exclusion criteria (17 listed)
- Subjects having a history of anaphylaxis or history consistent with persistent asthma
- Subjects taking antihistamines or nasal steroids medications greater than twice a week in the months of January and/or February.
- Subjects with chronic sinusitis unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the test drug or pose additional risk to the Subject.
- Subjects having perennial or structurally related rhinitis or rhinitis medicamentosa (from excessive use of nasal decongestants) that will interfere with the evaluation of symptoms due to ragweed allergy.
- Subjects with an FEV1 or PEF less than 80% predicted (moderate persistent asthma) with or without controller medication.
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 |
|---|---|---|
| Standardized Ragweed Allergenic ExtractStandardized Ragweed Allergenic Extract, sublingual oral | Biological | Ragweed Allergenic Extract |
| PlaceboPlacebo, sublingual oral | Biological | Placebo |
Primary outcome
Scores on a Scale (Average of Daily Rhinoconjunctivitis Symptom Score (RSS) Recorded During the Ragweed Season
Time frame: Ragweed pollen season, 08/01/08 to 10/30/08, approximately 3 months
Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable. The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season.
5 secondary outcomes
Scores on a Scale (Average Daily RSS During the Highest Pollen Count Week)
Time frame: 09/01/2008-09/07/2008
Scores on a Scale (Average Daily AM RSS and the Average Daily PM RSS During the Ragweed Season)
Time frame: Ragweed pollen season 08/01/08 to 10/30/08
Scores on a Scale (Average Daily RSS During the Ragweed Season for Each of the Three Organ) Systems (Ocular, Nasal, Ears);
Time frame: Ragweed pollen season 08/01/08 to 10/30/08
Scores on a Scale (Total Allergy Relief Medication Score During the Ragweed Season) for Each Subject
Time frame: Ragweed pollen season 08/01/08 to 10/30/08
Scores on a Scale (The Average Combined Allergy Symptom and Medication Score During the Ragweed Season for Each Subject)
Time frame: Ragweed pollen season 08/01/08 to 10/30/08
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- 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 E. Esch, PhD study director
Greer Laboratories, Inc.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standardized Ragweed Allergenic Extract in people with Allergic Rhinitis, run by Greer Laboratories at 30 sites 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 9 inclusion and 17 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 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites 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 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 14 Jan 2015). 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?
Scores on a Scale (Average of Daily Rhinoconjunctivitis Symptom Score (RSS) Recorded During the Ragweed Season (time frame: Ragweed pollen season, 08/01/08 to 10/30/08, approximately 3 months). 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 14 Jan 2015.