Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01721395
Recruitment Status : Completed
First Posted : November 4, 2012
Last Update Posted : October 23, 2015
Sponsor:
Collaborator:
Zarbee's Inc.
Information provided by (Responsible Party):
Ian M. Paul, M.D., M.Sc., Penn State University

Tracking Information
First Submitted Date  ICMJE October 26, 2012
First Posted Date  ICMJE November 4, 2012
Last Update Posted Date October 23, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2012)
Efficacy:Change in Cough Frequency based on parent responses to the Pediatric Cough Questionnaire [ Time Frame: Baseline (night 1) and End of night 2 ]
Change from baseline in cough frequency between the first night and the end of the second night. Parents/caregivers will complete a Pediatric Cough Questionnaire (a subjective parent report of cough) using a 0-6 point Likert scale with 0=not at all to 6=extremely often to assess frequency of cough. The same parent/caregiver that completed the questionnaire in the clinic will be asked to complete the questionnaire during the follow-up telephone call.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2012)
Efficacy: Change in Response to Other symptom responses on the Pediatric Cough Questionnaire(parental report) [ Time Frame: Change from Baseline (night 1) to End of Second Night ]
Change from baseline (night 1) and the end of the second night for each of the remaining questionnaire items pertaining to cough and cold symptoms and the symptoms affect on sleep. Parents/caregivers will complete a Pediatric Cough Questionnaire (a subjective parent report of cold symptoms) using a 0-6 point Likert scale with 0=not at all to 6=extremely often to assess cold symptoms.
  • severity of cough
  • bothersome nature of cough
  • how much the cough affected the child's and parent's/caregiver's ability to sleep
  • severity of stuffy nose
  • severity of runny nose The same parent/caregiver that completed the questionnaire in the clinic will be asked to complete the questionnaire during the follow-up telephone call.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents
Official Title  ICMJE Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents
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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cough
Intervention  ICMJE Dietary Supplement: Agave Syrup
Other Name: Zarbee's Naturals Agave Baby Cough Syrup
Study Arms  ICMJE
  • Placebo Comparator: Colored, Flavored water
    The placebo will be colored to approximate the reddish amber color of the agave syrup. The placebo will use the same flavoring used in the agave syrup. The placebo will be created in a GMP facility
    Intervention: Dietary Supplement: Agave Syrup
  • Experimental: Agave Syrup
    The formulation of pasteurized agave syrup consists of pasteurized agave syrup and natural flavoring.
    Intervention: Dietary Supplement: Agave Syrup
  • Sham Comparator: Air-filled oral syringe
    Air-filled oral syringe to match experimental and placebo arm
    Intervention: Dietary Supplement: Agave Syrup
Publications * Paul IM, Beiler JS, Vallati JR, Duda LM, King TS. Placebo effect in the treatment of acute cough in infants and toddlers: a randomized clinical trial. JAMA Pediatr. 2014 Dec;168(12):1107-13. doi: 10.1001/jamapediatrics.2014.1609.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2012)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 48 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01721395
Other Study ID Numbers  ICMJE ZB001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ian M. Paul, M.D., M.Sc., Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE Zarbee's Inc.
Investigators  ICMJE
Principal Investigator: Ian M Paul, MD, MSc Penn State University
PRS Account Penn State University
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP