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Study Summary
This trial tests the effectiveness of a medication, PQ Grass, to help with symptoms of seasonal allergies.
- Hay Fever
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have a history of severe allergic reactions that can be life-threatening, such as reactions to certain foods, insect bites, exercise, medications, or unknown causes.You have had a moderate to severe respiratory infection within the past 14 days that required medication.You have any other medical condition that could make it unsafe for you to participate in the study or could affect how well the treatment works. This includes conditions like heart problems, digestive issues, liver or kidney problems, blood disorders, neurological disorders, hormonal imbalances, or lung problems. The doctor will decide if it's safe for you to join the study based on your specific condition.You have a condition called non-allergic rhinitis or sinusitis, with or without polyps in your nose.You have had an allergic reaction or intolerance to the ingredients in the study drug or placebo.You have had a bad reaction or intolerance to the medications used to relieve allergy symptoms in this study.You have an ongoing cancer, serious heart or lung problems, severe mental illness, or weakened immune system.Your asthma is not well-controlled according to the current asthma guidelines.You have very severe asthma according to the latest guidelines from GINA (Global Initiative for Asthma).You have any skin conditions or tattoos that could make it harder to understand the results of a skin test.You have Type I diabetes or Type II diabetes that is not well controlled.You have very severe or uncontrolled asthma that is not well managed.Your asthma is severe and requires a high dose of inhaled medication every day.You have been previously put on a breathing machine for asthma.You have had a severe asthma attack that put your life in immediate danger.You have nasal polyps or chronic sinusitis.You have had a strong allergic reaction to allergen immunotherapy in the past.You have a medical history of hereditary angioedema.You have any eye problem, except for allergic conjunctivitis.You have a medical condition that could make it harder for you to recover from a severe allergic reaction.
- Group 1: Placebo
- Group 2: PQ Grass
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research endeavor recruiting participants who are 30 years of age and older?
"The qualifications to enroll in this clinical trial stipulate that participants must be aged 18-65."
Has PQ Grass been sanctioned by the FDA?
"Our experts at Power assigned a rating of 3 to PQ Grass due to the clinical evidence backing its efficacy and safety, which is expected with Phase 3 trials."
At how many venues is the clinical trials program administered?
"Currently, recruitment efforts for this medical trial are taking place at Allergy and Asthma Associates of Bluegrass in Lexington (KY), Family Allergy Asthma Research Institute in Louisville (ME), and Allergy & Asthma Specialists PSC in Owensboro (MD) as well as 89 other healthcare facilities."
Are there any openings for participation in this experiment at the moment?
"According to the list on clinicaltrials.gov, this experiment has concluded its recruitment phase and is not searching for patients anymore. Initially posted in October 11th 2022, the trial was last updated on July 31st 2023. Nonetheless, there are 87 other trials presently registering volunteers."
Is participation in this research endeavor open to me?
"The current trial is looking to recruit 1204 individuals aged 18-65 who suffer from hay fever, and adhere to the following criteria: 1) Capable of providing legally binding consent as outlined in Appendix 1; 2) Signed/dated Informed Consent Form; 3) Male or Female (with females meeting contraceptive requirements); 4) Generally healthy; 5) Experiences moderate-severe SAR/rhinoconjunctivitis symptoms for at least two seasons prior despite receiving allergy medication during said period; 6 ) Asthma must be well managed according to GINA Guidelines 2021 if present ; 7 ) Positive Skin Prick Test result to histamine"
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