Ragweed AllergyNCT01398137
Ragweed Observational Study
An observational study of Ragweed Allergy, run by Circassia Limited at 10 sites in United States.
Trial summary
This is an observational to evaluate Total Rhinoconjunctivitis Symptom Score and rescue medication usage (as measured by Rescue Medication Score as a Combined Score to inform the design of a phase III field study with ToleroMune Ragweed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ragweed Allergy
- How many people
- 90 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2011to Oct 2011
- Phase
- Observational
- 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
Study population: Subjects with a history of ragweed allergy for at least 2 years and which required symptomatic treatment for at least 1 year
Who may be able to join
- Male or female, aged 18-65 years.
- Reliable history of rhinoconjunctivitis and/or rhinoconjunctivitis plus controlled asthma on exposure to ragweed allergen for at least 2 years and required symptomatic treatment for at least 1 year.
- Positive skin prick test (SPT) to Ambrosia artemisiifolia
- Specific Immunoglobulin E (IgE) against Ambrosia artemisiifolia >0.35 kU/L
Who cannot join
- Positive skin test to any confounding, co-existing seasonal allergens likely to be present during the Pre-season baseline and ragweed pollen periods (grasses, miscellaneous weeds, fall trees) and who have received medication for these confounding seasonal allergies.
- Medical records of symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and have received medication for these perennial allergies
- Subjects with a history of severe drug allergy, severe angioedema or anaphylactic reaction to food or previous SPT for any allergen.
- Subjects with a history of any significant disease or disorder (e.g., cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, immunopathological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may influence the subject's ability to participate in this study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Canton, Ohio
Study site
Greenfield, Wisconsin
Study site
High Point, North Carolina
Study site
Minneapolis, Minnesota
Study site
Owensboro, Kentucky
Study site
Plymouth, Minnesota
Study site
Rolla, Missouri
Study site
Springfield, Virginia
Study site
St Louis, Missouri
Study site
Warrensburg, Missouri
About this study
Official title: An Observational Multi-Centre Field Study to Assess Symptom Scores and Rescue Medication Usage in Subjects With a History of Ragweed Allergen-Induced Rhinoconjunctivitis
This is an observational to evaluate Total Rhinoconjunctivitis Symptom Score and rescue medication usage (as measured by Rescue Medication Score as a Combined Score to inform the design of a phase III field study with ToleroMune Ragweed.
- Conditions
- Ragweed Allergy
- Keywords
- Ragweed allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ragweed allergic subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily Combined Score during the site-specific ragweed pollen period
Combined score is the Total Rhinoconjunctivitis Score(TRSS)/8 added to the Rescue Medication Score
Measured: Daily during ragweed season expected to last approximately 8 weeks
Secondary outcomes (9)
Mean Combined Score during the site-specific peak ragweed pollen period
Measured: Through 2011 ragweed season expected to last approximately 8 weeks
Mean TRSS during the site-specific ragweed pollen period
Measured: Through 2011 ragweed season expected to last approximately 8 weeks
Mean TRSS during the site-specific peak ragweed pollen period
Measured: Through 2011 ragweed season expected to last approximately 8 weeks
Mean Rescue Medication Score during the site-specific ragweed pollen period
Measured: Through 2011 ragweed season expected to last approximately 8 weeks
Mean Rescue Medication Score during the site-specific peak ragweed pollen period
Measured: Through 2011 ragweed season expected to last approximately 8 weeks
Mean component scores of the TRSS (nasal and non nasal) during the site specific ragweed pollen period
Measured: Through 2011 ragweed season expected to last approximately 8 weeks
Mean component scores of the TRSS (nasal and non nasal) during the site specific peak ragweed pollen period
Measured: Through 2011 ragweed season expected to last approximately 8 weeks
Mean Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score during the site specific peak ragweed pollen period in a subset of the study population
Measured: Through 2011 ragweed season approximately 8 weeks
Weeks of partly controlled or uncontrolled asthma
Measured: Through 2011 ragweed season expected to last approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ragweed AllergyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398137
- Sponsor's protocol ID
- TR003
- Status last verified
- Oct 2011
- First submitted
- 18 Jul 2011
- Last updated
- 27 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Multi-Centre Field Study to Assess Symptom Scores and Rescue Medication Usage in Subjects With a History of Ragweed Allergen-Induced Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT01398137
- Acronym / sponsor ID
- TR003
- Conditions
- Ragweed Allergy
- Keywords
- Ragweed allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Jul 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.
This is an observational to evaluate Total Rhinoconjunctivitis Symptom Score and rescue medication usage (as measured by Rescue Medication Score as a Combined Score to inform the design of a phase III field study with ToleroMune Ragweed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ragweed allergic subjects | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a history of ragweed allergy for at least 2 years and which required symptomatic treatment for at least 1 year
Key inclusion criteria (4 listed)
- Male or female, aged 18-65 years.
- Reliable history of rhinoconjunctivitis and/or rhinoconjunctivitis plus controlled asthma on exposure to ragweed allergen for at least 2 years and required symptomatic treatment for at least 1 year.
- Positive skin prick test (SPT) to Ambrosia artemisiifolia
- Specific Immunoglobulin E (IgE) against Ambrosia artemisiifolia >0.35 kU/L
Key exclusion criteria (4 listed)
- Positive skin test to any confounding, co-existing seasonal allergens likely to be present during the Pre-season baseline and ragweed pollen periods (grasses, miscellaneous weeds, fall trees) and who have received medication for these confounding seasonal allergies.
- Medical records of symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and have received medication for these perennial allergies
- Subjects with a history of severe drug allergy, severe angioedema or anaphylactic reaction to food or previous SPT for any allergen.
- Subjects with a history of any significant disease or disorder (e.g., cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, immunopathological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may influence the subject's ability to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean daily Combined Score during the site-specific ragweed pollen period
Time frame: Daily during ragweed season expected to last approximately 8 weeks
Combined score is the Total Rhinoconjunctivitis Score(TRSS)/8 added to the Rescue Medication Score
9 secondary outcomes
Mean Combined Score during the site-specific peak ragweed pollen period
Time frame: Through 2011 ragweed season expected to last approximately 8 weeks
Mean TRSS during the site-specific ragweed pollen period
Time frame: Through 2011 ragweed season expected to last approximately 8 weeks
Mean TRSS during the site-specific peak ragweed pollen period
Time frame: Through 2011 ragweed season expected to last approximately 8 weeks
Mean Rescue Medication Score during the site-specific ragweed pollen period
Time frame: Through 2011 ragweed season expected to last approximately 8 weeks
Mean Rescue Medication Score during the site-specific peak ragweed pollen period
Time frame: Through 2011 ragweed season expected to last approximately 8 weeks
Mean component scores of the TRSS (nasal and non nasal) during the site specific ragweed pollen period
Time frame: Through 2011 ragweed season expected to last approximately 8 weeks
Mean component scores of the TRSS (nasal and non nasal) during the site specific peak ragweed pollen period
Time frame: Through 2011 ragweed season expected to last approximately 8 weeks
Mean Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score during the site specific peak ragweed pollen period in a subset of the study population
Time frame: Through 2011 ragweed season approximately 8 weeks
Weeks of partly controlled or uncontrolled asthma
Time frame: Through 2011 ragweed season expected to last approximately 8 weeks
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 27 Oct 2011.
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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ragweed Allergy, run by Circassia Limited at 10 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 4 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 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Mean daily Combined Score during the site-specific ragweed pollen period (time frame: Daily during ragweed season expected to last approximately 8 weeks). 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 27 Oct 2011.