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Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents

This study is currently recruiting participants.
Verified January 2013 by Penn State University
Sponsor:
Collaborator:
Zarbee's Inc.
Information provided by (Responsible Party):
Ian M. Paul, M.D., M.Sc., Penn State University
ClinicalTrials.gov Identifier:
NCT01721395
First received: October 26, 2012
Last updated: February 11, 2013
Last verified: January 2013
History of Changes
  Purpose

Cough is a frequent symptom in children and infants and is one of the most common reasons parents visit a healthcare provider for their child. The US Food and Drug Administration has issued a warning that over-the-counter cough and cold medicines including antihistamines, decongestants, anti-tussives, and expectorants should not be administered to children younger than 2 years of age due not only to lack of proven efficacy, but also because of important safety concerns. Honey, another method of soothing cough cannot be used in children <1 year due to concerns for infantile botulism. A preparation from agave syrup has been created to address the need for an infant cough syrup. Although no studies have formally evaluated the use of agave nectar for nocturnal cough associated with Upper Respiratory Infections, the demulcent effect and sweet taste of agave nectar may provide some relief from cough in children.


Condition Intervention
Cough
 Dietary Supplement: Agave Syrup

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents

Resource links provided by NLM:

MedlinePlus related topics: Cough
U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Efficacy:Change in Cough Frequency based on parent responses to the Pediatric Cough Questionnaire [ Time Frame: Baseline (night 1) and End of night 2 ] [ Designated as safety issue: No ]
    Change from baseline in cough frequency between the first night and the end of the second night. Parents/caregivers will complete a Pediatric Cough Questionnaire (a subjective parent report of cough) using a 0-6 point Likert scale with 0=not at all to 6=extremely often to assess frequency of cough. The same parent/caregiver that completed the questionnaire in the clinic will be asked to complete the questionnaire during the follow-up telephone call.


Secondary Outcome Measures:
  • Efficacy: Change in Response to Other symptom responses on the Pediatric Cough Questionnaire(parental report) [ Time Frame: Change from Baseline (night 1) to End of Second Night ] [ Designated as safety issue: No ]

    Change from baseline (night 1) and the end of the second night for each of the remaining questionnaire items pertaining to cough and cold symptoms and the symptoms affect on sleep.

    Parents/caregivers will complete a Pediatric Cough Questionnaire (a subjective parent report of cold symptoms) using a 0-6 point Likert scale with 0=not at all to 6=extremely often to assess cold symptoms.

    • severity of cough
    • bothersome nature of cough
    • how much the cough affected the child's and parent's/caregiver's ability to sleep
    • severity of stuffy nose
    • severity of runny nose The same parent/caregiver that completed the questionnaire in the clinic will be asked to complete the questionnaire during the follow-up telephone call.


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Colored, Flavored water
The placebo will be colored to approximate the reddish amber color of the agave syrup. The placebo will use the same flavoring used in the agave syrup. The placebo will be created in a GMP facility
Experimental: Agave Syrup
The formulation of pasteurized agave syrup consists of pasteurized agave syrup and natural flavoring.
 Dietary Supplement: Agave Syrup
Other Name: Zarbee's Naturals Agave Baby Cough Syrup
No Intervention: Air-filled oral syringe
Air-filled oral syringe to match experimental and placebo arm

  Eligibility

Ages Eligible for Study:   2 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Otherwise healthy male or female infant who is 2 to <48 months of age.
  • presents with a non-specific acute cough for 7 or fewer days' duration.
  • Parents/legal authorized representative reporting at least moderate cough and cold symptoms.
  • Parent/legal authorized representative was in the home with the child on the night prior to enrollment and plans to be in the home with the child on the night when study treatment will be administered
  • Parent/legal authorized representative who is willing and able to comply with study requirements.

Exclusion Criteria:

  • Previous participation in this clinical trial
  • Gestational age at birth <35 weeks.
  • Signs or symptoms of a more treatable disease (eg, asthma, pneumonia, laryngotracheobronchitis, sinusitis, allergic rhinitis).
  • Diagnosis of influenza, bronchiolitis or respiratory syncytial virus (RSV).
  • History of reactive airways disease, asthma, or chronic lung disease.
  • Use of any medication or honey to treat cough within 6 hours of bedtime on the evening prior to or on the day of enrollment.
  • Presence of any significant disease including immunodeficiency, hepatic, renal,cardiovascular, or hematologic disease or any other health condition that, in the opinion of the investigator, would preclude participation in the study.
  • Known allergy to agave nectar or grape flavoring
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721395

Contacts
Contact: Ian M Paul, MD, MSc 717-531-8006 ipaul@hmc.psu.edu
Contact: Jessica SB Beiler, MPH 717-531-5656 jbeiler@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Zarbee's Inc.
Investigators
Principal Investigator: Ian M Paul, MD, MSc Penn State University
  More Information

No publications provided

Responsible Party: Ian M. Paul, M.D., M.Sc., Professor of Pediatrics and Public Health Sciences, Penn State University
ClinicalTrials.gov Identifier: NCT01721395     History of Changes
Other Study ID Numbers: ZB001
Study First Received: October 26, 2012
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Cough
Nocturnal Cough
Agave
Sleep Quality
Childhood cough

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013