Ragweed Observational Study

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01398137
First received: July 18, 2011
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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
Ragweed Allergy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Mean daily Combined Score during the site-specific ragweed pollen period [ Time Frame: Daily during ragweed season expected to last approximately 8 weeks ] [ Designated as safety issue: No ]
    Combined score is the Total Rhinoconjunctivitis Score(TRSS)/8 added to the Rescue Medication Score


Secondary Outcome Measures:
  • Mean Combined Score during the site-specific peak ragweed pollen period [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ] [ Designated as safety issue: No ]
  • Mean TRSS during the site-specific ragweed pollen period [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ] [ Designated as safety issue: No ]
  • Mean TRSS during the site-specific peak ragweed pollen period [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ] [ Designated as safety issue: No ]
  • Mean Rescue Medication Score during the site-specific ragweed pollen period [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ] [ Designated as safety issue: No ]
  • Mean Rescue Medication Score during the site-specific peak ragweed pollen period [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Weeks of partly controlled or uncontrolled asthma [ Time Frame: Through 2011 ragweed season expected to last approximately 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: July 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ragweed allergic subjects

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01398137     History of Changes
Other Study ID Numbers: TR003
Study First Received: July 18, 2011
Last Updated: October 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Circassia Limited:
Ragweed allergy

Additional relevant MeSH terms:
Hypersensitivity
Rhinitis, Allergic, Seasonal
Immune System Diseases
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 31, 2014