Ragweed Observational Study

October 26, 2011 updated by: Circassia Limited

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Owensboro, Kentucky, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Plymouth, Minnesota, United States
    • Missouri
      • Rolla, Missouri, United States
      • St Louis, Missouri, United States
      • Warrensburg, Missouri, United States
    • North Carolina
      • High Point, North Carolina, United States
    • Ohio
      • Canton, Ohio, United States
    • Virginia
      • Springfield, Virginia, United States
    • Wisconsin
      • Greenfield, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with a history of ragweed allergy for at least 2 years and which required symptomatic treatment for at least 1 year

Description

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Ragweed allergic subjects

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Daily during ragweed season expected to last approximately 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean Combined Score during the site-specific peak ragweed pollen period
Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks
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
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
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
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
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
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
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
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
Through 2011 ragweed season expected to last approximately 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Circassia Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Quintiles, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TR003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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