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Ragweed Observational Study

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ClinicalTrials.gov Identifier: NCT01398137
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : October 27, 2011
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Circassia Limited

Brief 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.

Condition or disease
Ragweed Allergy

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : July 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Group/Cohort
Ragweed allergic subjects



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mean Combined Score during the site-specific peak ragweed pollen period [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ]
  2. Mean TRSS during the site-specific ragweed pollen period [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ]
  3. Mean TRSS during the site-specific peak ragweed pollen period [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ]
  4. Mean Rescue Medication Score during the site-specific ragweed pollen period [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ]
  5. Mean Rescue Medication Score during the site-specific peak ragweed pollen period [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. Weeks of partly controlled or uncontrolled asthma [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398137


Locations
United States, Kentucky
Owensboro, Kentucky, United States
United States, Minnesota
Minneapolis, Minnesota, United States
Plymouth, Minnesota, United States
United States, Missouri
Rolla, Missouri, United States
St Louis, Missouri, United States
Warrensburg, Missouri, United States
United States, North Carolina
High Point, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
United States, Virginia
Springfield, Virginia, United States
United States, Wisconsin
Greenfield, Wisconsin, United States
Sponsors and Collaborators
Circassia Limited
Quintiles, Inc.

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01398137     History of Changes
Other Study ID Numbers: TR003
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: October 27, 2011
Last Verified: October 2011

Keywords provided by Circassia Limited:
Ragweed allergy