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

NCT01588249 | Terminated

• 1 other identifier: ZMCS-6441
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Cough; Upper Respiratory Infection; Nocturnal Cough

Outcome Measures

Primary Outcomes (1)

• Change from baseline in cough frequency between the first night and the end of the second night.

  baseline and day 2

Study Arms (2)

Novel formulation of pasteurized maple cough syrup

EXPERIMENTAL

Dietary Supplement: Pasteurized maple syrup

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Pasteurized maple syrup DIETARY_SUPPLEMENT

Novel formulation of pasteurized maple cough syrup

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Otherwise healthy male or female infant who is between 0 and 12 months of age.
• Presents to clinic with a URI characterized by the presence of rhinorrhea and cough for 7 or fewer days' duration.
• Patient is an appropriate candidate, in the judgment of the investigator, to participate in the study.
• 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).
• Parent/legal authorized representative provides written informed consent for child to participate in study.
• Parent/caregiver who is willing and able to comply with study requirements.

You may not qualify if:

• Signs or symptoms of a more treatable disease (eg, asthma, pneumonia, laryngotrachebronchitis, sinusitis, allergic rhinitis).
• Diagnosis of influenza, bronchiolitis or respiratory syncytial virus (RSV).
• History of reactive airways disease, asthma, or chronic lung disease.
• 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.

Sponsors & Collaborators

• Zarbee's Inc.: lead
• Advanced Clinical Research Services, LLC: collaborator

Study Sites (3)

Willow Creek Pediatrics

Draper, Utah, United States

Location

Families First Pediatrics

South Jordan, Utah, United States

Location

Southwest Children's Clinic

West Jordan, Utah, United States

Location

MeSH Terms

Conditions

Cough; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

US (3)