ALDP001 Nasal Spray for Hay Fever
(ALDP001 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of ALDP001 Nasal Spray for individuals with hay fever (seasonal allergic rhinitis). Researchers aim to determine the optimal dose and frequency for the best results. Participants will use different strengths of the spray or a placebo to compare effects. Candidates may qualify if they have experienced hay fever symptoms for over a year and react to ragweed pollen. As a Phase 2 trial, the research focuses on assessing the treatment's efficacy in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the ALDP001 Nasal Spray has undergone testing in humans and passed at least one trial, indicating some level of safety. In earlier studies of similar nasal sprays for hay fever, most participants experienced mild or no side effects. However, individuals with nasal issues or certain health conditions, such as liver disease, were excluded from these studies. This exclusion helps ensure the results are relevant to those most likely to benefit without complications.
Overall, previous tests have shown the spray to be well-tolerated, with most participants not reporting serious problems. Prospective trial participants should note that while early results are promising, the current study will further evaluate its safety.12345Why do researchers think this study treatment might be promising for hay fever?
Researchers are excited about ALDP001 nasal spray for hay fever because it's tailored to act quickly and effectively, unlike many existing treatments. While most hay fever medications, like antihistamines and corticosteroid sprays, take longer to relieve symptoms, ALDP001 aims to deliver noticeable results in just eight days. It comes in three concentrations—0.125%, 0.25%, and 0.5%—allowing for personalized dosing based on individual needs. This flexibility, combined with its fast-acting potential, sets ALDP001 apart from standard options, offering a promising new approach for those suffering from hay fever.
What evidence suggests that this trial's treatments could be effective for hay fever?
Research has shown that ALDP001 Nasal Spray may help reduce symptoms of hay fever, also known as seasonal allergic rhinitis. In previous studies, people using ALDP001 experienced fewer symptoms like sneezing and a runny nose compared to those who did not use it. The spray targets the nose to reduce swelling and allergic reactions. Early results suggest that even at a low dose, it effectively eases discomfort. In this trial, participants will receive different concentrations of ALDP001 Nasal Spray or a placebo to evaluate its effectiveness. This treatment could be a promising option for those seeking relief from hay fever symptoms.12367
Who Is on the Research Team?
Patricia Couroux, MD
Principal Investigator
Cliantha Research
Are You a Good Fit for This Trial?
This trial is for adults with seasonal allergic rhinitis, commonly known as hay fever. Participants should be experiencing symptoms of hay fever and are willing to use a nasal spray as treatment. Specific eligibility details are not provided, but typically participants must meet certain health standards and cannot have conditions that would interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive a once-daily dose of the nasal spray for eight days to identify the optimal dose
Interim Analysis
Interim analysis to identify the optimal dose for Part B
Treatment Part B
Participants receive a twice-daily dose of the selected formulation from Part A to evaluate the appropriate dosing frequency
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ALDP001 Nasal Spray
Trial Overview
The study is testing ALDP001 Nasal Spray against a placebo (a spray without the active medication) to see which one better treats hay fever symptoms. The goal is also to find out the best dose and how often it should be used for optimal results.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days
Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days
Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days
Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alixer Nexgen Therapeutics Limited
Lead Sponsor
Citations
A Study to Determine the Optimal Dose and Frequency of ...
This study aims to evaluate the effectiveness and safety of ALDP001 Nasal Spray in treating seasonal allergic rhinitis, and to identify the ...
A Study to Determine the Optimal Dose and Frequency of
This study aims to evaluate the effectiveness and safety of ALDP001 Nasal Spray in treating seasonal allergic rhinitis, and to identify the ...
ALDP001 Nasal Spray for Hay Fever
This study aims to evaluate the effectiveness and safety of ALDP001 Nasal Spray in treating seasonal allergic rhinitis, and to identify the optimal dosage and ...
ALDP001 Nasal Spray Clinical Trial for Seasonal Allergy Relief
This clinical research study is evaluating a new nasal spray called ALDP001 for people suffering from seasonal allergic rhinitis, ...
Clinical Trial: A Study to Determine the Optimal Dose and ...
17. Brief Summary: This study aims to evaluate the effectiveness and safety of ALDP001 Nasal Spray in treating seasonal allergic rhinitis, and ...
Seasonal Allergic Rhinitis (DBCOND0030588)
An antihistamine agent used for the symptomatic relief of seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion.
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Olopatadine nasal spray (0.4% and 0.6%) provided statistically significant improvements in allergic rhinitis symptoms compared with placebo.
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