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A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population

Primary Purpose

Upper Respiratory Tract Infections

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
North American ginseng
Placebo
Sponsored by
Afexa Life Sciences Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Respiratory Tract Infections focused on measuring URTI, Natural Health Products

Eligibility Criteria

3 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy individuals of both genders aged years 3 - 11
  2. Willing to adhere to the requirements of the protocol, including availability for follow-up visits
  3. Parent/guardian willing and able to sign written consent

Exclusion Criteria:

  1. Medical conditions:

    • Asthma requiring treatment in the last 3 months with oral steroids - prednisone greater than 10 mg/day
    • Received influenza vaccination for the winter season when the trial is run.
    • Active tuberculosis
    • Cystic fibrosis
    • Significant pulmonary disorders (chronic bronchitis, emphysema or other chronic respiratory illness)
    • Any ongoing allergen immunotherapy during study or for 6 months prior HIV/AIDS
    • Malignancy (under active observation or treatment)
    • Unstable cardiovascular disease (physician visit or hospitalization for unstable cardiovascular disease in the last 6 months)
    • Known renal abnormalities (serum creatinine known to be > upper limit for age group)
    • Acute or active chronic liver disease
    • Diabetes
    • Neurological or psychiatric disease (progressive or currently under treatment)
    • Bleeding disorders
    • Major surgery in the last 6 months or planned surgery over the course of the study
    • Crohn's disease, Juvenile arthritis, Ulcerative Colitis or any other autoimmune disease
    • Other serious medical conditions

  2. Medications:

    • Medications for allergic rhinitis/conjunctivitis, including: antihistamines; oral, parenteral, nasal, and ophthalmic corticosteroids; cromolyn sodium; nedocromil; and intranasal anticholinergics (If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.)
    • Oral or long-acting beta-agonists, theophylline, and leukotriene modifiers
    • Phenelzine
    • Pentobarbital
    • Haloperidol
    • Warfarin
    • Heparin

    • Immunosuppressants

      • Any other natural health products or dietary supplements, with the exception of vitamins and minerals with dose of <600 mg/day of vitamin E and containing no vitamin K. Natural health products or dietary supplements include products such as, but not limited to, Echinacea, Ginseng (beverages, foods, extracts, capsules, or tablets), St. John's Wort, Gingko, Glucosamine, Fish Oil supplements, Evening Primrose Oil, Green Tea or other herbal products consumed in the form of a pill or capsule. (If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.)
  3. Known allergy to any ingredient in the study product or placebo, including: ginseng, icing sugar, stevia leaf powder, mixed berries natural flavour (MC010946), grape natural flavour (MC010947) or caramel color liquid (DN700 caramelan 8-110).

Sites / Locations

  • Alberta Health Services
  • Saint John Regional Hospital
  • Canadian Center for Vaccinology, Dalhousie University
  • JDM Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The primary objective is to assess the efficacy of acute dosing of CVT-E002 in reducing the duration of URTI symptoms in children 3-11 years of age

Secondary Outcome Measures

To asses the efficacy of acute dosing of CVT-E002 in reducing: (1) symptom severity; (2) peak CARIFS scores and; (3) absenteeism for participant and/or parent/guardian.

Full Information

First Posted
August 25, 2009
Last Updated
August 30, 2012
Sponsor
Afexa Life Sciences Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00965822
Brief Title
A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population
Official Title
A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Afexa Life Sciences Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Parents with children aged 3-11 will participate in this study. About 500 children will take part in the study. We expect about half of those children will develop symptoms of a respiratory infection. Active participation in this study will last 14 days after a parent reports symptoms of a respiratory infection in a participant. Those children who do meet the study criteria of symptoms will then be randomly placed (like a flip of a coin) into one of 2 groups to take either COLD-FX® or placebo for 3 days. A placebo will look exactly like COLD-FX® but contains no active ingredients. The participant has an equal chance of being placed in either of the above groups. The study is double-blind, so neither the participant nor the study staff will know which study group the participant was placed in until the study is completed. If this information is needed in an emergency at any time throughout the study, it is quickly available from the sponsor. Participation in the study will be for 14 days after symptoms of a respiratory infection are reported to study staff. Your child will take the study product for 3 days, you will complete a daily diary, receive 4 phone calls and be seen for a final study visit to review the diary and complete a final health check of your child.
Detailed Description
The primary objective is to assess the efficacy of acute dosing of CVT-E002 in reducing the duration of URTI symptoms in children 3-11 years of age. The secondary objectives are to asses the efficacy of acute dosing of CVT-E002 in reducing: (1) symptom severity; (2) peak CARIFS scores and; (3) absenteeism for participant and/or parent/guardian. The ease of administration and the safety of acute dosing of CVT-E002 in children 3-11 years of age will also be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections
Keywords
URTI, Natural Health Products

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
North American ginseng
Other Intervention Name(s)
COLD-FX
Intervention Description
3 day, once daily, dosing
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
3 day, once daily dosing
Primary Outcome Measure Information:
Title
The primary objective is to assess the efficacy of acute dosing of CVT-E002 in reducing the duration of URTI symptoms in children 3-11 years of age
Time Frame
14 days
Secondary Outcome Measure Information:
Title
To asses the efficacy of acute dosing of CVT-E002 in reducing: (1) symptom severity; (2) peak CARIFS scores and; (3) absenteeism for participant and/or parent/guardian.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy individuals of both genders aged years 3 - 11 Willing to adhere to the requirements of the protocol, including availability for follow-up visits Parent/guardian willing and able to sign written consent Exclusion Criteria: Medical conditions: Asthma requiring treatment in the last 3 months with oral steroids - prednisone greater than 10 mg/day Received influenza vaccination for the winter season when the trial is run. Active tuberculosis Cystic fibrosis Significant pulmonary disorders (chronic bronchitis, emphysema or other chronic respiratory illness) Any ongoing allergen immunotherapy during study or for 6 months prior HIV/AIDS Malignancy (under active observation or treatment) Unstable cardiovascular disease (physician visit or hospitalization for unstable cardiovascular disease in the last 6 months) Known renal abnormalities (serum creatinine known to be > upper limit for age group) Acute or active chronic liver disease Diabetes Neurological or psychiatric disease (progressive or currently under treatment) Bleeding disorders Major surgery in the last 6 months or planned surgery over the course of the study Crohn's disease, Juvenile arthritis, Ulcerative Colitis or any other autoimmune disease Other serious medical conditions Medications: Medications for allergic rhinitis/conjunctivitis, including: antihistamines; oral, parenteral, nasal, and ophthalmic corticosteroids; cromolyn sodium; nedocromil; and intranasal anticholinergics (If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.) Oral or long-acting beta-agonists, theophylline, and leukotriene modifiers Phenelzine Pentobarbital Haloperidol Warfarin Heparin Immunosuppressants Any other natural health products or dietary supplements, with the exception of vitamins and minerals with dose of <600 mg/day of vitamin E and containing no vitamin K. Natural health products or dietary supplements include products such as, but not limited to, Echinacea, Ginseng (beverages, foods, extracts, capsules, or tablets), St. John's Wort, Gingko, Glucosamine, Fish Oil supplements, Evening Primrose Oil, Green Tea or other herbal products consumed in the form of a pill or capsule. (If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.) Known allergy to any ingredient in the study product or placebo, including: ginseng, icing sugar, stevia leaf powder, mixed berries natural flavour (MC010946), grape natural flavour (MC010947) or caramel color liquid (DN700 caramelan 8-110).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelly McNeil, FRCPC
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Health Services
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5N 4A3
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L4L2
Country
Canada
Facility Name
Canadian Center for Vaccinology, Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
JDM Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4P 1P2
Country
Canada

12. IPD Sharing Statement

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A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population

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