A Novel Formulation of Pasteurized Maple Cough Syrup Compared With Placebo on Nocturnal Cough and Sleep Quality in Infants With Upper Respiratory Infection



Status:Recruiting
Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:April 2012
Contact:Jeremy Rigby
Email:jrigby@acr-research.com
Phone:801-542-8190

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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. A product that has been used in alternative medicine for cough is
maple syrup. Although no studies have formally evaluated the use of maple syrup for
nocturnal cough associated with URI, the demulcent effect of maple syrup may provide some
relief from cough in children. A novel formulation of pasteurized maple cough syrup, when
compared to placebo, should provide superior relief on nocturnal cough and the sleep
difficulty associated with URI in children under 12 months and sleep difficulty of their
parent/caregiver.


Inclusion Criteria

1. Otherwise healthy male or female infant who is between 0 and 12 months of age.

2. Presents to clinic with a URI characterized by the presence of rhinorrhea and cough
for 7 or fewer days' duration.

3. Patient is an appropriate candidate, in the judgment of the investigator, to
participate in the study.

4. Parents/caregivers provide an answer of at least "somewhat" (3 points on a 7-point
Likert scale) for a minimum of 2 of the 3 questions related to nocturnal cough
frequency, effect on child's sleep, and effect on parental/caregiver sleep based on
the previous night's symptoms (see Section 11.0).

5. Parent/legal authorized representative provides written informed consent for child to
participate in study.

6. Parent/caregiver who is willing and able to comply with study requirements.

Exclusion Criteria

1. Signs or symptoms of a more treatable disease (eg, asthma, pneumonia,
laryngotrachebronchitis, sinusitis, allergic rhinitis).

2. Diagnosis of influenza, bronchiolitis or respiratory syncytial virus (RSV).

3. History of reactive airways disease, asthma, or chronic lung disease.

4. Use of any medication to treat cough within 6 hours of bedtime on the evening prior
to or on the day of enrollment. (Use of analgesic medications such as acetaminophen
or ibuprofen is not exclusionary.)

5. 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.
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West Jordan, Utah
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