BridgeMD
New treatment option for Hypersensitivity
Official title Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges
ClinicalTrials.gov ID: NCT07038746
What this study is testing
What is Inhaled Epinephrine?
Inhaled Epinephrine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hypersensitivity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this exploratory study is to evaluate the effects of inhaled epinephrine in subjects, who may not be eligible for the GHL-101 trial, and who are experiencing systemic allergic reaction (SAR) that occur following allergy testing, subcutaneous immunotherapy (SCIT), oral challenges (with food and/or drug) or oral immunotherapy (OIT).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Males or females, aged ≥ 12 years with known or suspected allergen sensitivity who can also have a clinical history of immunoglobulin E...
- Have undergone either a) allergy testing for suspected sensitivity/allergy, b) future oral challenge (food and/or drug) or future OIT to treat...
- For females of child-bearing potential, not pregnant or lactating, willing to use an acceptable contraception\ method between Screening and...
You likely can't join if
- Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
- Known history or presence of clinically disease/condition that could confound the results of the study or place the subject at undue or additional...
- Abnormal vital signs at screening (i.e., systolic blood pressure: \ 140 mmHg, diastolic blood pressure: \ 90 mmHg or, heart rate: \ 100 bpm)...
- Females who are pregnant, plan to become pregnant or lactating.
- Participation in another clinical study involving an investigational drug within 30 days prior to screening, an investigational biologic within 60...
- Previous treatment in this study.
See the full eligibility criteria
- Males or females, aged ≥ 12 years with known or suspected allergen sensitivity who can also have a clinical history of immunoglobulin E (IgE)-mediated allergy, including a documented sensitivity to allergens (i.e...
- Have undergone either a) allergy testing for suspected sensitivity/allergy, b) future oral challenge (food and/or drug) or future OIT to treat existing allergies or c) SCIT AND experienced a SAR Grade 2 or higher...
- For females of child-bearing potential, not pregnant or lactating, willing to use an acceptable contraception\ method between Screening and End-of-Study Visits.
- Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
- Known history or presence of clinically disease/condition that could confound the results of the study or place the subject at undue or additional risk per the judgment of the Investigator.
- Abnormal vital signs at screening (i.e., systolic blood pressure: \ 140 mmHg, diastolic blood pressure: \ 90 mmHg or, heart rate: \ 100 bpm), respiration rate \ 20 resp./min.
- Females who are pregnant, plan to become pregnant or lactating.
- Participation in another clinical study involving an investigational drug within 30 days prior to screening, an investigational biologic within 60 days prior to screening, or current/planned participation in another...
- Previous treatment in this study.
- Any other reason that, in the opinion of the Investigator, is likely to unfavorably alter subject risk-benefit, confound results, or make it difficult for the subject to fully comply with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.