Ragweed Observational Study
This study has been completed.
Sponsor:
Circassia Limited
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
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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
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 May 22, 2013