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New treatment option for Mild or Moderate Asthma With Allergic Sensitization
Official title 5HTP Regulation Of Asthma In Children
ClinicalTrials.gov ID: NCT04160910
What this study is testing
What is 5-Hydroxytryptophan?
5-Hydroxytryptophan is an investigational medicine, being studied as a potential treatment for mild or moderate asthma with allergic sensitization.
Also referred to as 5HTP.
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 purpose of this study is to learn more about if taking a supplement called 5-hydroxytryptophan (5HTP) can improve breathing and anxiety symptoms related to asthma. To help learn more subjects will either be assigned to a group that is taking the supplement (5HTP) or a group that is taking a placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 18
You may be able to join if
- Age 8-18 Years of Age
- Mild to Moderate Asthma based on ATS guidelines
- Positive Allergy Test (positive skin or serum IgE)
- Weight ≥ 70 lbs (32 kg)
- CES-DC cut-off ≥ 15 (total score range is 0 to 60) or SCARED cut-off
You likely can't join if
- Currently taking a SSRI
- Taking a leukotriene inhibitor (montelukast, Zileuton)
- Severe Asthma Based on ATS Guidelines
- Taking a biologic medication (omalizumab, mepolizumab, benralizumab, dupilumab)
- Medical History of Adverse Reaction to 5HTP
- Physical findings that would compromise the safety of the study or the quality of the study data
See the full eligibility criteria
- Age 8-18 Years of Age
- Mild to Moderate Asthma based on ATS guidelines
- Positive Allergy Test (positive skin or serum IgE)
- Weight ≥ 70 lbs (32 kg)
- CES-DC cut-off ≥ 15 (total score range is 0 to 60) or SCARED cut-off
- 25 (total score range is 0 to 142)
- Ability to comply with study visits and study procedures
- Informed Consent by participant and if applicable the parent or legal guardian
- Currently taking a SSRI
- Taking a leukotriene inhibitor (montelukast, Zileuton)
- Severe Asthma Based on ATS Guidelines
- Taking a biologic medication (omalizumab, mepolizumab, benralizumab, dupilumab)
- Medical History of Adverse Reaction to 5HTP
- Physical findings that would compromise the safety of the study or the quality of the study data
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
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, 8 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. 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.