NCT05956691

AllerPops Reduce Nasal Symptoms in Adult Volunteers With Allergic Rhinitis

A Phase II, Randomized, Double-blind, Controlled, Single-centre 21-day Study to Investigate the Efficacy of AllerPops to Reduce Nasal Symptoms in Adult Volunteers With Seasonal/Year-long Nasal Allergies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: AllerPops Corp · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test AllerPops' effectiveness in people who suffer from allergic rhinitis. The main question\[s\]it aims to answer are: 1. To assess the effectiveness of AllerPops on relieving nasal symptoms compared to the control group in volunteers with seasonal/year-long allergies during the first 7 days of the 21-day intervention period. 2. To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period. Up to 30 days between Screening (V1) and Baseline (V2), and a 21-day intervention period, with dosing occurring every other day for a minimum of 3 doses, and thereafter until the participant is satisfied with the relief of the nasal allergy symptoms. The suitable season for the trial will be determined based on the seasonal variation measures. Researchers will compare slow and fast consuming groups to see if the way of use impact the effectiveness.

Detailed description

Duration: Up to 30 days between Screening (V1) and Baseline (V2), and a 21-day intervention period, with dosing occurring every other day for a minimum of 3 doses, and thereafter until the participant is satisfied with the relief of the nasal allergy symptoms. The suitable season for the trial will be determined based on the seasonal variation measures. Primary Objectives: To assess the effectiveness of AllerPops on relieving nasal symptoms compared to the control group in volunteers with seasonal/year-long allergies during the first 7 days of the 21-day intervention period. Secondary Objective: 1. To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period. 2. To assess the duration of effectiveness of AllerPops in relieving nasal symptoms compared to the control group in volunteers with seasonal/year-long allergies during a 21-day intervention period (exploratory). 3. To evaluate the effect of the AllerPops administration on the oral microbial presentation/microbiota using Amplicon Metagenomics Sequencing test through saliva samples during a 21-day intervention period (exploratory). 4. To evaluate the effect of the AllerPops administration on the IgE (total) blood level during a 21-day intervention period (exploratory). Study Population: Seventy-two participants with seasonal/year-long nasal allergies. Duration: Up to 30 days between Screening (V1) and Baseline (V2), and a 21-day intervention period, with dosing occurring every other day for a minimum of 3 doses, and thereafter until the participant is satisfied with the relief of the nasal allergy symptoms. The suitable season for the trial will be determined based on the seasonal variation measures. Primary Objectives: To assess the effectiveness of AllerPops on relieving nasal symptoms compared to the control group in volunteers with seasonal/year-long allergies during the first 7 days of the 21-day intervention period. Secondary Objective: 1. To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period. 2. To assess the duration of effectiveness of AllerPops in relieving nasal symptoms compared to the control group in volunteers with seasonal/year-long allergies during a 21-day intervention period (exploratory). 3. To evaluate the effect of the AllerPops administration on the oral microbial presentation/microbiota using Amplicon Metagenomics Sequencing test through saliva samples during a 21-day intervention period (exploratory). 4. To evaluate the effect of the AllerPops administration on the IgE (total) blood level during a 21-day intervention period (exploratory). Study Population: Seventy-two participants with seasonal/year-long nasal allergies.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AllerPops	Take AllerPops once every other day, as instructed, for a minimum of 3 doses. After each dose, wait at least 30 minutes before eating your next meal. After the 3rd dose, you may continue every other day until you are satisfied with the symptom relief up to and including Day 13.

Timeline

• Start date: 2022-04-05
• Primary completion: 2022-09-05
• Completion: 2022-09-21
• First posted: 2023-07-21
• Last updated: 2023-07-24

Locations

1 site across 1 country: Canada