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

NCT01721395 | Completed DMC

• 1 other identifier: ZB001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cough

Keywords

Cough; Nocturnal Cough; Agave; Sleep Quality; Childhood cough

Outcome Measures

Primary Outcomes (1)

• Efficacy:Change in Cough Frequency based on parent responses to the Pediatric Cough Questionnaire

  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.

  Baseline (night 1) and End of night 2

Secondary Outcomes (1)

• Efficacy: Change in Response to Other symptom responses on the Pediatric Cough Questionnaire(parental report)

  Change from Baseline (night 1) to End of Second Night

Study Arms (3)

Colored, Flavored water

PLACEBO COMPARATOR

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

Dietary Supplement: Agave Syrup

Agave Syrup

EXPERIMENTAL

The formulation of pasteurized agave syrup consists of pasteurized agave syrup and natural flavoring.

Dietary Supplement: Agave Syrup

Air-filled oral syringe

SHAM COMPARATOR

Air-filled oral syringe to match experimental and placebo arm

Dietary Supplement: Agave Syrup

Interventions

Agave Syrup DIETARY_SUPPLEMENT

Also known as: Zarbee's Naturals Agave Baby Cough Syrup

Agave Syrup; Air-filled oral syringe; Colored, Flavored water

Eligibility Criteria

• Age: 2 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• Zarbee's Inc.: collaborator

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• Paul IM, Beiler JS, Vallati JR, Duda LM, King TS. Placebo effect in the treatment of acute cough in infants and toddlers: a randomized clinical trial. JAMA Pediatr. 2014 Dec;168(12):1107-13. doi: 10.1001/jamapediatrics.2014.1609.

  PMID: 25347696 DERIVED

MeSH Terms

Conditions

Cough; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ian M Paul, MD, MSc

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Public Health Sciences

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: November 5, 2012
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 23, 2015

Record last verified: 2015-10

Locations

US (1)