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Antihistamine

Chlor-Trimeton for Voice Disorder

Q: Is the recruitment phase of this clinical trial still ongoing?

According to the information available on clinicaltrials.gov, this trial is currently in search of eligible participants. The initial posting was made on June 13, 2023, and it has been updated most recently on January 29, 2024.

Q: What is the overall count of individuals involved in this research endeavor?

Indeed, the information on clinicaltrials.gov indicates that this trial is actively seeking eligible participants. The trial was first posted on June 13th, 2023 and last updated on January 29th, 2024. Currently, there is a need for a total of 10 participants who will be recruited from one designated site.

Q: Is the age criterion for participation in this medical study inclusive of individuals younger than 35 years?

To be eligible for this research study, participants must fall between the ages of 18 and 35.

Q: What specific criteria must individuals meet to be eligible for enrollment in this medical study?

To be eligible for this research study, candidates must possess a voice disorder and be aged between 18 and 35. The trial is currently accepting approximately 10 participants.

Phase < 1

Recruiting

Research Sponsored by Auburn University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ability to comfortably breathe through both their nose and mouth

have diagnosed allergies of the upper airway

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline fundamental frequency at 3 hours

Awards & highlights

Study Summary

This trial is studying the effects of a common over-the-counter antihistamine on voice function in individuals with allergies. The main question is whether taking this antihistamine makes voice function worse.

Who is the study for?

This trial is for individuals aged 18-35 with diagnosed upper airway allergies, who can match pitch vocally and have a SNOT-22 score of at least 20. They must be free from laryngeal pathologies, voice disorders, drying medications (except antihistamines), reflux, respiratory diseases, diabetes, neurological issues, hormone imbalances and not be pregnant or breastfeeding in the last 6 months. Active smokers are excluded.Check my eligibility

What is being tested?

The study tests if first-generation OTC antihistamine Chlor-Trimeton worsens voice function in allergy sufferers. Participants take one dose and undergo voice assessments before and three hours after to measure changes using clinical perceptual, acoustic, aerodynamic measures and laryngeal imaging.See study design

What are the potential side effects?

Chlor-Trimeton may cause lower sedation and fewer anticholinergic effects compared to similar drugs but could potentially lead to negative changes in vocal function as perceived by participants and researchers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can breathe easily through both my nose and mouth.

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I have allergies affecting my nose or throat.

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I have never had a voice disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline fundamental frequency at 3 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline fundamental frequency at 3 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline fundamental frequency at 3 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cepstral peak prominence (decibels, dB)

Fundamental frequency (Hertz)

Harmonic-to-Noise ratio (decibels, dB)

+6 more

Side effects data

From 1996 Phase 3 trial • 679 Patients • NCT03879772

18%

Headache

10%

Epistaxis

Asthma

Oropharyngeal pain

Cough

Pyrexia

Sneezing

Nausea

Abdominal pain upper

Vomiting

Pathological fracture

100%

80%

60%

40%

20%

Study treatment Arm

MFNS 25 mcg QD

MFNS 100 mcg QD

Placebo

MFNS 200 mcg QD

BDP 84 mcg BID

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chlor-TrimetonExperimental Treatment1 Intervention

Package recommended dose of over the counter Chlor-Trimeton will be administered to assess voice function before and 3 hours after taking it.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Auburn UniversityLead Sponsor

72 Previous Clinical Trials

14,395 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this clinical trial still ongoing?

"According to the information available on clinicaltrials.gov, this trial is currently in search of eligible participants. The initial posting was made on June 13, 2023, and it has been updated most recently on January 29, 2024."

Answered by AI

What is the overall count of individuals involved in this research endeavor?

"Indeed, the information on clinicaltrials.gov indicates that this trial is actively seeking eligible participants. The trial was first posted on June 13th, 2023 and last updated on January 29th, 2024. Currently, there is a need for a total of 10 participants who will be recruited from one designated site."

Answered by AI

Is the age criterion for participation in this medical study inclusive of individuals younger than 35 years?

"To be eligible for this research study, participants must fall between the ages of 18 and 35."

Answered by AI

What specific criteria must individuals meet to be eligible for enrollment in this medical study?

"To be eligible for this research study, candidates must possess a voice disorder and be aged between 18 and 35. The trial is currently accepting approximately 10 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-generation OTC Antihistamine Use and Voice Function: A Preliminary Study

Mary J. Sandage 2023. "First-generation OTC Antihistamine Use and Voice Function: A Preliminary Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05858216.