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Completed

NCT Number: NCT01398137

Ragweed Observational Study

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Owensboro, Kentucky, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 20, 2011
Registry last updated
Oct 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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