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

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721395
• Other study ID #: ZB001
• Status: Completed
• Phase: N/A
• First received: October 26, 2012
• Last updated: October 22, 2015
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: October 2015
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 48 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cough

Intervention

Dietary Supplement:
• Agave Syrup

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Zarbee's Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy:Change in Cough Frequency based on parent responses to the Pediatric Cough Questionnaire	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.	Baseline (night 1) and End of night 2	No
Secondary	Efficacy: Change in Response to Other symptom responses on the Pediatric Cough Questionnaire(parental report)	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.	Change from Baseline (night 1) to End of Second Night	No