Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | March 2014 |
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.
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.
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
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