Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00127686
Other study ID # 21163
Secondary ID
Status Completed
Phase Phase 1
First received August 4, 2005
Last updated November 21, 2017
Start date September 2005
Est. completion date December 2006

Study information

Verified date November 2017
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cough is the most common reason for an acute care doctor's visit in the United States. Cough can affect sleep for both coughing children and their parents. The American Academy of Pediatrics does not endorse the use of dextromethorphan (DM), the most common over-the-counter (OTC) cough medication because of a lack of efficacy data and some potential for toxicity, particularly when taken in excess. In fact, DM has previously been shown to be no better than a placebo for cough in children. Therefore, alternative, therapeutic agents are needed. Honey anecdotally provides relief for symptoms due to upper respiratory tract infection (URI). This study seeks to use a survey to evaluate whether a single dose of honey and/or DM is better than no treatment at all for controlling nocturnal cough in children with URI and the effect of the treatments on sleep quality for coughing children and their parents. A single dose of honey or DM will be superior to no treatment for control of nocturnal cough due to upper URI as rated by both parents and children and will improve the sleep quality for those children and parents. Compared to DM, honey will be superior for controlling nocturnal cough due to upper URI (also based on child and parental report).


Description:

Cough is one of the most common reasons for a doctor's visit in the United States and may be the most bothersome symptom for children with colds. It is particularly annoying at night because it can interrupt sleep for both coughing children and their parents. Dextromethorphan (DM), the most common over-the-counter (OTC) "cough medication," may not be as helpful for these symptoms as previously believed. Because of this, treatments are needed to better reduce the symptoms from a cold. Honey is a naturally occurring substance that may provide relief for cold symptoms. Children are being offered the opportunity to take part in this research because they have been diagnosed with a cold and have had difficulty sleeping due to their cough.

The purpose of this research is to use a survey to see if a single dose of honey or DM is better than no treatment at all for controlling nighttime cough in children, ages 2 to less than 18 years with a cold and if the medicine or honey helps the quality of sleep for the coughing children and their parents. DM has been approved by the Food and Drug Administration (FDA) and is available over the counter. The form of honey used in this study may also be purchased without a doctor's prescription.

About 125 male and female children from 2 to less than 18 years old will take part in this study at the Hershey Medical Center.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria:

- Ages 2 to <18 years

- Cough due to upper respiratory tract infection (URI), as determined by physical examination

- Sleep difficulty on the preceding night attributed to frequent cough

- Ability to swallow liquids

- Willingness of the child's guardian to participate in a survey

Exclusion Criteria:

- Signs/symptoms of more serious/treatable disease

- Itchy, watery eyes

- Frequent sneezing, tachypnea (respiratory rate >95th percentile) or labored breathing; symptoms for 8 or more days.

- History of asthma in the past 2 years

- Chronic lung disease, or seizure disorder

- Allergic reaction to honey or DM

- Selective serotonin reuptake inhibitors (SSRIs) or anti-malarial drugs

- Diabetes mellitus or signs/symptoms of insulin resistance

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dextromethorphan

Buckwheat Honey


Locations

Country Name City State
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Penn State University National Honey Board

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compared with no treatment, honey and DM will: improve the sleep quality for children with cough due to URI and improve the sleep quality for the parents of children with cough due to URI 1 year
See also
  Status Clinical Trial Phase
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04537663 - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults Phase 4
Terminated NCT04583280 - A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV) Phase 3
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Active, not recruiting NCT03251196 - TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
Completed NCT02561871 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers Phase 1
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Terminated NCT02032056 - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period N/A
Completed NCT01419262 - DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers Phase 3
Terminated NCT01432080 - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant Phase 2
Completed NCT00984945 - Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults Phase 1
Active, not recruiting NCT01107223 - Long Term Effect of General Practitioner Education on Antibiotic Prescribing N/A
Completed NCT03739112 - Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly Phase 3
Completed NCT04144491 - Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda N/A
Completed NCT05318235 - Virus Interactions in the Respiratory Tract; a Cohort Study With Children
Active, not recruiting NCT04170348 - Daily Vitamin D for Sickle-cell Respiratory Complications Phase 2
Completed NCT04525040 - ProbioKid as Prevention Among Kids With Frequent URTI N/A
Completed NCT05535777 - Patient Portal Flu Vaccine Reminders_RCT 5 (LADHS) N/A
Not yet recruiting NCT05914324 - Outpatient Pediatric Pulse Oximeters in Africa N/A
Completed NCT04533685 - Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- UCLA Portal R/R Influenza RCT 3 N/A