Back to results

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

Primary Purpose

Cough

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Agave Syrup

About this trial

This is an interventional treatment trial for Cough focused on measuring Cough, Nocturnal Cough, Agave, Sleep Quality, Childhood cough

Eligibility Criteria

2 Months - 48 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Sham Comparator

Arm Label

Colored, Flavored water

Agave Syrup

Air-filled oral syringe

Arm Description

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

The formulation of pasteurized agave syrup consists of pasteurized agave syrup and natural flavoring.

Air-filled oral syringe to match experimental and placebo arm

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01721395

First Posted

October 26, 2012

Last Updated

October 22, 2015

Sponsor

Penn State University

Collaborators

Zarbee's Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01721395

Brief Title

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

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Penn State University

Collaborators

Zarbee's Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cough

Keywords

Cough, Nocturnal Cough, Agave, Sleep Quality, Childhood cough

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Colored, Flavored water

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Agave Syrup

Arm Type

Experimental

Arm Description

The formulation of pasteurized agave syrup consists of pasteurized agave syrup and natural flavoring.

Arm Title

Air-filled oral syringe

Arm Type

Sham Comparator

Arm Description

Air-filled oral syringe to match experimental and placebo arm

Intervention Type

Dietary Supplement

Intervention Name(s)

Agave Syrup

Other Intervention Name(s)

Zarbee's Naturals Agave Baby Cough Syrup

Primary Outcome Measure Information:

Title

Efficacy:Change in Cough Frequency based on parent responses to the Pediatric Cough Questionnaire

Description

Time Frame

Baseline (night 1) and End of night 2

Secondary Outcome Measure Information:

Title

Efficacy: Change in Response to Other symptom responses on the Pediatric Cough Questionnaire(parental report)

Description

Time Frame

Change from Baseline (night 1) to End of Second Night

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

48 Months

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ian M Paul, MD, MSc

Organizational Affiliation

Penn State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25347696

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs