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

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Cough

Treatments: Dietary Supplement: Agave Syrup

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01721395

ZB001

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 2 to 48 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Colored, Flavored water

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Agave Syrup

Agave Syrup

Experimental group

Description:

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

Treatment:

Dietary Supplement: Agave Syrup

Air-filled oral syringe

Sham Comparator group

Description:

Air-filled oral syringe to match experimental and placebo arm

Treatment:

Dietary Supplement: Agave Syrup