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

This study has been terminated.
(Revisiting product options)
Sponsor:
Collaborator:
Advanced Clinical Research
Information provided by (Responsible Party):
Zarbee's Inc.
ClinicalTrials.gov Identifier:
NCT01588249
First received: April 26, 2012
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Cough
Upper Respiratory Infection
Nocturnal Cough
Dietary Supplement: Pasteurized maple syrup
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Zarbee's Inc.:

Primary Outcome Measures:
  • Change from baseline in cough frequency between the first night and the end of the second night. [ Time Frame: baseline and day 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Novel formulation of pasteurized maple cough syrup Dietary Supplement: Pasteurized maple syrup
Placebo Comparator: Placebo Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588249

Locations
United States, Utah
Willow Creek Pediatrics
Draper, Utah, United States
Families First Pediatrics
South Jordan, Utah, United States
Southwest Children's Clinic
West Jordan, Utah, United States
Sponsors and Collaborators
Zarbee's Inc.
Advanced Clinical Research
  More Information

No publications provided

Responsible Party: Zarbee's Inc.
ClinicalTrials.gov Identifier: NCT01588249     History of Changes
Other Study ID Numbers: ZMCS-6441
Study First Received: April 26, 2012
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cough
Respiratory Tract Infections
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Infection

ClinicalTrials.gov processed this record on August 28, 2014