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Completed

NCT Number: NCT01353079

Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy

The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season.

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 7

Warrenton, Virginia, 20186, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • allergic to ragweed

Exclusion criteria

  • not allergic to ragweed
  • history of anaphylaxis
  • subject with chronic sinusitis, unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological disease
  • Asthmatic subjects with FEV1 or PEF less than or equal to 80% predicted
  • Subjects who have received experimental drug within 30 days prior to study admission
  • Subjects who have received anit-IgE medications in the last 12 months
  • Subjects who have received ragweed immunotherapy in the last 3 years
  • Subjects who are currently users of inhaled, intramuscular, or intravenous corticosteroids, tricyclic anti-depressants, beta blockers, and MAO inhibitors
  • Subjects refusing to sign epi-pen training form
  • Females who are pregnant or breast feeding

Treatment and study plan

Short Ragweed Pollen Allergenic Extract

Biological

Daily sublingual administration of Short Ragweed Pollen Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.

Placebo

Biological

Placebo: Glycero-COCAs sublingual

Primary outcomes

  1. Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores]

    Time frame: 2011 ragweed pollen season, 8/2011 -10/2011

    Change in baseline in avg combined daily RSS and medication scores during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Maximum medication score dependent on cumulative rescue medication use. Lower result is more favorable. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.

Secondary outcomes

  1. Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season)

    Time frame: 3 peak weeks of the 2011 ragweed pollen season

    Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, watery eyes/tears), nasal (sneezing, itching, runny, stuffy nose), and ears (itching). Avg daily RSS computed by summing 8 individual allergy symptoms recorded in AM and PM; forming daily RSS by summing AM and PM RSS for each day; averaging daily RSS for three peak weeks. Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Max medication score dependent on cumulative rescue medication use. Lower result, more favorable. Three peak weeks of ragweed pollen counts during entire ragweed season was contiguous and calculated using a moving average of ragweed pollen counts for each week. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.

  2. Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season)

    Time frame: 2011 ragweed pollen season; 8/2011 - 10/2011

    Change in baseline in avg daily RSS during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.

  3. Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of Ragweed Pollen Season)

    Time frame: 3 peak weeks of the 2011 ragweed pollen season

    Change from baseline in avg daily rhinoconjunctivitis symptom scores during the three peak weeks of ragweed pollen season for the ITT population (netpRSS).

    Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for three peak weeks of ragweed pollen season.

Sponsors and collaborators

Lead sponsor

Greer Laboratories

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled, Parallel Group Efficacy And Safety Trial Of Sublingual-Oral Immunotherapy (SLIT) In Adults With Allergic Rhinoconjunctivitis Caused By Ragweed Pollen

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 12, 2011
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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