Clinical trial NCT01721395: Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents
Official title: Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cough
Keywords: Cough
Nocturnal Cough
Agave
Sleep Quality
Childhood cough
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Zarbee's Inc.
First posted: 2012-11-04
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 48
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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy:Change in Cough Frequency based on parent responses to the Pediatric Cough Questionnaire
timeFrame: Baseline (night 1) and End of night 2
Secondary outcomes:
measure: Efficacy: Change in Response to Other symptom responses on the Pediatric Cough Questionnaire(parental report)
timeFrame: Change from Baseline (night 1) to End of Second Night
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Ian M Paul, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.