Ragweed Observational Study

Completed

• Conditions: Ragweed Allergy

• Registration Number: NCT01398137
• Lead Sponsor: Circassia Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-26
• Last Update Posted: 2011-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean daily Combined Score during the site-specific ragweed pollen period	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 Outcome Measures

Name	Time	Method
Mean Combined Score during the site-specific peak ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
Mean TRSS during the site-specific ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
Mean TRSS during the site-specific peak ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
Mean Rescue Medication Score during the site-specific ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
Mean Rescue Medication Score during the site-specific peak ragweed pollen period	Through 2011 ragweed season expected to last approximately 8 weeks
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
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
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
Weeks of partly controlled or uncontrolled asthma	Through 2011 ragweed season expected to last approximately 8 weeks