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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Upper Respiratory Tract Infections
- Sponsor
- Afexa Life Sciences Inc
- Enrollment
- 293
- Locations
- 4
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
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 Outcomes
- 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.(14 days)