NCT01398137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 27, 2011

Status Verified

October 1, 2011

Enrollment Period

3 months

First QC Date

July 18, 2011

Last Update Submit

October 26, 2011

Conditions

Ragweed Allergy

Keywords

Ragweed allergy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

Ragweed allergic subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Owensboro, Kentucky, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Plymouth, Minnesota, United States

Location

Unknown Facility

Rolla, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Warrensburg, Missouri, United States

Location

Unknown Facility

High Point, North Carolina, United States

Location

Unknown Facility

Canton, Ohio, United States

Location

Unknown Facility

Springfield, Virginia, United States

Location

Unknown Facility

Greenfield, Wisconsin, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 20, 2011

Study Start

July 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 27, 2011

Record last verified: 2011-10

Locations

US(10)