CoughNCT01588249
A Novel Formulation of Pasteurized Maple Cough Syrup Compared With Placebo on Nocturnal Cough and Sleep Quality in Infants With Upper Respiratory Infection
A study testing Pasteurized maple syrup in people with Cough and Upper Respiratory Infection, run by Zarbee's Inc. at 3 sites 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 Up to 12 months
- Conditions the study is for
- Cough, Upper Respiratory Infection, Nocturnal Cough
- What is being tested?
- Pasteurized maple syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2012to Jun 2012
- 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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Otherwise healthy male or female infant who is between 0 and 12 months of age.
- Presents to clinic with a URI characterized by the presence of rhinorrhea and cough for 7 or fewer days' duration.
- Patient is an appropriate candidate, in the judgment of the investigator, to participate in the study.
- Parents/caregivers provide an answer of at least "somewhat" (3 points on a 7-point Likert scale) for a minimum of 2 of the 3 questions related to nocturnal cough frequency, effect on child's sleep, and effect on parental/caregiver sleep based on the previous night's symptoms (see Section 11.0).
- Parent/legal authorized representative provides written informed consent for child to participate in study.
- Parent/caregiver who is willing and able to comply with study requirements.
Who cannot join
- Signs or symptoms of a more treatable disease (eg, asthma, pneumonia, laryngotrachebronchitis, 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 to treat cough within 6 hours of bedtime on the evening prior to or on the day of enrollment. (Use of analgesic medications such as acetaminophen or ibuprofen is not exclusionary.)
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Willow Creek Pediatrics
Draper, Utah
Families First Pediatrics
South Jordan, Utah
Southwest Children's Clinic
West Jordan, Utah
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. A product that has been used in alternative medicine for cough is maple syrup. Although no studies have formally evaluated the use of maple syrup for nocturnal cough associated with URI, the demulcent effect of maple syrup may provide some relief from cough in children. A novel formulation of pasteurized maple cough syrup, when compared to placebo, should provide superior relief on nocturnal cough and the sleep difficulty associated with URI in children under 12 months and sleep difficulty of their parent/caregiver.
- Conditions
- Cough, Upper Respiratory Infection, Nocturnal Cough
- Being tested
- Pasteurized maple syrup, Placebo
- Medical subject headings
- Cough, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasteurized maple syrupDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Novel formulation of pasteurized maple cough syrup | Experimental | Not described Receives: Dietary Supplement: Pasteurized maple syrup |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cough frequency between the first night and the end of the second night.
Measured: baseline and day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Revisiting product options
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zarbee's Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588249
- Sponsor's protocol ID
- ZMCS-6441
- Status last verified
- Oct 2012
- First submitted
- 26 Apr 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Formulation of Pasteurized Maple Cough Syrup Compared With Placebo on Nocturnal Cough and Sleep Quality in Infants With Upper Respiratory Infection
- ClinicalTrials.gov ID
- NCT01588249
- Acronym / sponsor ID
- ZMCS-6441
- Conditions
- Cough, Upper Respiratory Infection, Nocturnal Cough
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Revisiting product options
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zarbee's Inc.Industry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Apr 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. A product that has been used in alternative medicine for cough is maple syrup. Although no studies have formally evaluated the use of maple syrup for nocturnal cough associated with URI, the demulcent effect of maple syrup may provide some relief from cough in children. A novel formulation of pasteurized maple cough syrup, when compared to placebo, should provide superior relief on nocturnal cough and the sleep difficulty associated with URI in children under 12 months and sleep difficulty of their parent/caregiver.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel formulation of pasteurized maple cough syrup | Experimental | Dietary Supplement: Pasteurized maple syrup |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Otherwise healthy male or female infant who is between 0 and 12 months of age.
- Presents to clinic with a URI characterized by the presence of rhinorrhea and cough for 7 or fewer days' duration.
- Patient is an appropriate candidate, in the judgment of the investigator, to participate in the study.
- Parents/caregivers provide an answer of at least "somewhat" (3 points on a 7-point Likert scale) for a minimum of 2 of the 3 questions related to nocturnal cough frequency, effect on child's sleep, and effect on parental/caregiver sleep based on the previous night's symptoms (see Section 11.0).
- Parent/legal authorized representative provides written informed consent for child to participate in study.
Key exclusion criteria (5 listed)
- Signs or symptoms of a more treatable disease (eg, asthma, pneumonia, laryngotrachebronchitis, 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 to treat cough within 6 hours of bedtime on the evening prior to or on the day of enrollment. (Use of analgesic medications such as acetaminophen or ibuprofen is not exclusionary.)
- 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.
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 |
|---|---|---|
| Pasteurized maple syrup | Dietary supplement | Novel formulation of pasteurized maple cough syrup |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Change from baseline in cough frequency between the first night and the end of the second night.
Time frame: baseline and day 2
Results and safety
The study was stopped early (reason given: Revisiting product options). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pasteurized maple syrup in people with Cough and Upper Respiratory Infection, run by Zarbee's Inc. at 3 sites 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Revisiting product options). Results are not available in the source record.
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?
Change from baseline in cough frequency between the first night and the end of the second night. (time frame: baseline and day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2012.