Clinical trial NCT01588249: A Novel Formulation of Pasteurized Maple Cough Syrup Compared With Placebo on Nocturnal Cough and Sleep Quality in Infants With Upper Respiratory Infection
Official title: A Novel Formulation of Pasteurized Maple Cough Syrup Compared With Placebo on Nocturnal Cough and Sleep Quality in Infants With Upper Respiratory Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cough
Upper Respiratory Infection
Nocturnal Cough
Lead sponsor: Zarbee's Inc.
Sponsor class: INDUSTRY
Collaborators: name: Advanced Clinical Research Services, LLC
First posted: 2012-04-30
Enrollment: 80
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in cough frequency between the first night and the end of the second night.
timeFrame: baseline and day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Draper
country: United States
facility: Willow Creek Pediatrics
state: Utah
city: South Jordan
country: United States
facility: Families First Pediatrics
state: Utah
city: West Jordan
country: United States
facility: Southwest Children's Clinic
state: Utah
Study officials:
References: