Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of TOLAMBA™ in the Control of Symptoms of Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
NCT number | NCT00537355 |
Other study ID # | DV1-SAR-11 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | September 2007 |
Est. completion date | May 2008 |
Verified date | April 2019 |
Source | Dynavax Technologies Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter
study. After passing the initial Screening Visit, subjects will be in the environmental
exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each
day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total
Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo
treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the
study drug. About three weeks after the last injection, subjects will be asked to be in the
EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after
Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits
13-16, Days 82-85).
During all EEC visits, the subjects will be exposed to ragweed pollen at an average
concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours.
During each EEC visit, patients will be asked to record symptom scores for nasal and
non-nasal symptoms at scheduled time points.
The total duration of a subject's participation in this study is expected to be a minimum of
85 days.
Status | Completed |
Enrollment | 271 |
Est. completion date | May 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Is willing and able to give signed informed consent, and must have provided this consent. - Has a clinical history of seasonal allergic rhinitis with seasonal nasal allergy symptoms during each of the last 2 ragweed allergy seasons. - Has documentation of a positive skin test to ragweed allergen within 12 months of screening. - Has minimum qualifying symptom scores at the last visit of the Pre-Treatment EEC sessions (Visit 5, Day 4). - If female of childbearing potential, is not pregnant and is consistently using an acceptable birth control method. - Is normally active and otherwise judged to be in good health on the basis of medical history, physical examination and routine laboratory tests. Exclusion Criteria: - A woman who is pregnant, breastfeeding, or planning a pregnancy. - Has a history of more than mild asthma that requires the use of a daily inhaled or oral corticosteroid, leukotriene inhibitor, or cromolyn; or a daily inhaled short or long acting ß-agonist. - Has had any hospital admissions for asthma, a recent (within the past 12 months)asthma exacerbation that required either oral or inhaled corticosteroids, or a prior history of unstable asthma. - Has received immunotherapy within the last 2 years that has contained ragweed pollen extract. - Has previously participated in a clinical trial with TOLAMBA or another ragweed-based immunotherapy. - Has received immunotherapy for any allergens within 30 days prior to Visit 1. - Has the need for use of antihistamines or corticosteroids on a regular basis (systemic or topical). - Has received anti-immunoglobulin E (IgE) antibody (Xolair®) within the past 12 months. - Is currently taking monoamine oxidase (MAO) inhibitors. - Has taken any systemic corticosteroids, immunomodulators, or immune suppressive medications within 4 weeks prior to Visit 1. - Has taken any antihistamine within 7 days prior to Visit 1 skin testing. - Requires use of ß-adrenergic blockers or other agents that may interfere with the use of adrenaline. - Known current alcohol or drug abuse. - Current participation in another clinical study involving an investigational drug or device, or participation in such a study within 30 days prior to Visit 1. - Has a history of generalized anaphylaxis requiring medical attention. - Has moderate or severe allergy symptoms at Visit 1. |
Country | Name | City | State |
---|---|---|---|
Canada | Allied Research International Inc. | Mississauga | Ontario |
Canada | Alpha Medical Research Inc. | Mississauga | Ontario |
Canada | Anapharm | Montreal | Quebec |
Canada | Division of Clinical Immunology and Allergy, The McGill University Health Centre | Montreal | Quebec |
Canada | Allergy & Asthma Research Centre | Ottawa | Ontario |
Canada | Centre De Recherche Appliquée en Allergie De Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Dynavax Technologies Corporation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Nasal Symptom Score (TNSS) | 3 months | ||
Secondary | Total Non-Nasal Symptom Score (TNNSS) | 3 months | ||
Secondary | Total Symptom Score (TSS) | 3 months | ||
Secondary | quality of life questionnaire | 3 months |
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