CoughNCT01721395
Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents
A study testing Agave Syrup in people with Cough, run by Penn State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 to 48 months
- Conditions the study is for
- Cough
- What is being tested?
- Agave Syrup
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
- Conditions
- Cough
- Being tested
- Agave Syrup
- Keywords
- Cough, Nocturnal Cough, Agave, Sleep Quality, Childhood cough
- Medical subject headings
- Cough, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agave SyrupDietary supplement
Also called Zarbee's Naturals Agave Baby Cough Syrup
| Study group | Role | What they receive |
|---|---|---|
| Colored, Flavored water | Placebo comparator | 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 Receives: Dietary Supplement: Agave Syrup |
| Agave Syrup | Experimental | The formulation of pasteurized agave syrup consists of pasteurized agave syrup and natural flavoring. Receives: Dietary Supplement: Agave Syrup |
| Air-filled oral syringe | Sham comparator | Air-filled oral syringe to match experimental and placebo arm Receives: Dietary Supplement: Agave Syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (night 1) and End of night 2
Secondary outcomes (1)
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.
Measured: Change from Baseline (night 1) to End of Second Night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Zarbee's Inc.
- Responsible party
- Principal investigator, Ian M. Paul, M.D., M.Sc., Penn State University
- Investigators
- Ian M Paul, MD, MSc, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721395
- Sponsor's protocol ID
- ZB001
- Status last verified
- Oct 2015
- First submitted
- 26 Oct 2012
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25347696
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Agave Syrup, Placebo, and No Treatment on Nocturnal Cough and Sleep Quality for Coughing Infants/Toddlers and Their Parents
- ClinicalTrials.gov ID
- NCT01721395
- Acronym / sponsor ID
- ZB001
- Conditions
- Cough
- Keywords
- Cough, Nocturnal Cough, Agave, Sleep Quality, Childhood cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Zarbee's Inc.
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colored, Flavored water | Placebo comparator | Dietary Supplement: Agave SyrupThe 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 |
| Agave Syrup | Experimental | Dietary Supplement: Agave SyrupThe formulation of pasteurized agave syrup consists of pasteurized agave syrup and natural flavoring. |
| Air-filled oral syringe | Sham comparator | Dietary Supplement: Agave SyrupAir-filled oral syringe to match experimental and placebo arm |
Who may qualify
- Ages
- 2 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agave SyrupAlso: Zarbee's Naturals Agave Baby Cough Syrup | Dietary supplement | Agave Syrup, Air-filled oral syringe, Colored, Flavored water |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
- Derived from this study: PubMed 25347696Paul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian M Paul, MD, MSc principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agave Syrup in people with Cough, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy:Change in Cough Frequency based on parent responses to the Pediatric Cough Questionnaire (time frame: Baseline (night 1) and End of night 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01721395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.