Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study (NCT03682965) | Clinical Trial Compass
CompletedPhase 2
Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
United States21 participantsStarted 2018-09-28
Plain-language summary
TX-SMILE is an investigator-initiated, multi-center, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety, and tolerability of intra-lymphatic administration of an approved allergenic extract for the immunotherapy treatment of allergic rhinitis and conjunctivitis due to pollen from the conifer Mountain Cedar.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Both male and female adult patients with a history of Season Allergic Rhinitis (SAR) with bothersome symptoms due to Mountain Cedar pollinosis confirmed using the Modified Quantitate Test (MQT; defined as a wheal greater than or equal to 3 millimeters larger than the diluent control)
✓. Patients must be willing to provide written, informed consent
✓. Patients must be willing and able to comply with study procedures
✓. Women of childbearing potential must agree to use an acceptable form of contraception during the trial
Exclusion criteria
✕. Patients less than 18 years of age
✕. Clinically-significant chronic sinusitis, as determined by the investigator
✕. History of anaphylaxis during Mountain Cedar skin prick testing
✕. Participation in another clinical trial or use of an experimental medication within 30 days of enrollment
✕. Medically significant co-morbidities that, in the opinion of the investigator, place the subject at increased risk during the study, including but not limited to:
✕. Autoimmune diseases, other than allergic rhinitis (AR), stable allergic asthma, eczema and food sensitivities
✕. Pulmonary or respiratory diseases other than stable asthma