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

Allergy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353079
• Other study ID #: SLIT10-01
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2011
• Last updated: January 22, 2015
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: January 2015
• Source: Greer Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: April 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Biological:
• Short Ragweed Pollen Allergenic Extract
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
Placebo: Glycero-COCAs sublingual

Locations

Country	Name	City	State
United States	Site 7	Warrenton	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Greer Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores]	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.	2011 ragweed pollen season, 8/2011 -10/2011	No
Secondary	Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of 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.	3 peak weeks of the 2011 ragweed pollen season	No
Secondary	Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season)	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.	2011 ragweed pollen season; 8/2011 - 10/2011	No
Secondary	Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of 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.	3 peak weeks of the 2011 ragweed pollen season	No