Ragweed Observational Study

Ragweed Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398137
• Other study ID #: TR003
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: October 26, 2011
• Start date: July 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ragweed Allergy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean daily Combined Score during the site-specific ragweed pollen period	Combined score is the Total Rhinoconjunctivitis Score(TRSS)/8 added to the Rescue Medication Score	Daily during ragweed season expected to last approximately 8 weeks	No
Secondary	Mean Combined Score during the site-specific peak ragweed pollen period		Through 2011 ragweed season expected to last approximately 8 weeks	No
Secondary	Mean TRSS during the site-specific ragweed pollen period		Through 2011 ragweed season expected to last approximately 8 weeks	No
Secondary	Mean TRSS during the site-specific peak ragweed pollen period		Through 2011 ragweed season expected to last approximately 8 weeks	No
Secondary	Mean Rescue Medication Score during the site-specific ragweed pollen period		Through 2011 ragweed season expected to last approximately 8 weeks	No
Secondary	Mean Rescue Medication Score during the site-specific peak ragweed pollen period		Through 2011 ragweed season expected to last approximately 8 weeks	No
Secondary	Mean component scores of the TRSS (nasal and non nasal) during the site specific ragweed pollen period		Through 2011 ragweed season expected to last approximately 8 weeks	No
Secondary	Mean component scores of the TRSS (nasal and non nasal) during the site specific peak ragweed pollen period		Through 2011 ragweed season expected to last approximately 8 weeks	No
Secondary	Mean Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score during the site specific peak ragweed pollen period in a subset of the study population		Through 2011 ragweed season approximately 8 weeks	No
Secondary	Weeks of partly controlled or uncontrolled asthma		Through 2011 ragweed season expected to last approximately 8 weeks	No