Clinical trial NCT01398137: Ragweed Observational Study
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ragweed Allergy
Keywords: Ragweed allergy
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2011-07-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: Mean daily Combined Score during the site-specific ragweed pollen period
timeFrame: Daily during ragweed season expected to last approximately 8 weeks
Secondary outcomes:
measure: Mean Combined Score during the site-specific peak ragweed pollen period
timeFrame: Through 2011 ragweed season expected to last approximately 8 weeks
measure: Mean TRSS during the site-specific ragweed pollen period
timeFrame: Through 2011 ragweed season expected to last approximately 8 weeks
measure: Mean TRSS during the site-specific peak ragweed pollen period
timeFrame: Through 2011 ragweed season expected to last approximately 8 weeks
measure: Mean Rescue Medication Score during the site-specific ragweed pollen period
timeFrame: Through 2011 ragweed season expected to last approximately 8 weeks
measure: Mean Rescue Medication Score during the site-specific peak ragweed pollen period
timeFrame: Through 2011 ragweed season expected to last approximately 8 weeks
measure: Mean component scores of the TRSS (nasal and non nasal) during the site specific ragweed pollen period
timeFrame: Through 2011 ragweed season expected to last approximately 8 weeks
measure: Mean component scores of the TRSS (nasal and non nasal) during the site specific peak ragweed pollen period
timeFrame: Through 2011 ragweed season expected to last approximately 8 weeks
measure: Mean Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score during the site specific peak ragweed pollen period in a subset of the study population
timeFrame: Through 2011 ragweed season approximately 8 weeks
measure: Weeks of partly controlled or uncontrolled asthma
timeFrame: Through 2011 ragweed season expected to last approximately 8 weeks
Other outcomes:
Locations:
city: Owensboro
country: United States
state: Kentucky
city: Minneapolis
country: United States
state: Minnesota
city: Plymouth
country: United States
state: Minnesota
city: Rolla
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Warrensburg
country: United States
state: Missouri
city: High Point
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Springfield
country: United States
state: Virginia
city: Greenfield
country: United States
state: Wisconsin
Study officials:
References: