Track topics on Twitter Track topics that are important to you
Parents with children aged 3-11 will participate in this study. About 400 children will take part in the study. We expect about half of those children will develop symptoms of a respiratory infection. This study will last about 6 months, during which time parents will be instructed to contact study staff if their child has symptoms of a respiratory infection. 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 liquid COLD-fX® or placebo for 3 days. A placebo will look exactly like liquid COLD-fX® but contains no active ingredients. Your child has an equal chance of being placed in either of the above groups. Neither you nor the study staff will know which study group your child 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.
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Upper Respiratory Tract Infections
North American ginseng, Placebo
Alberta Health Services
Afexa Life Sciences Inc
Published on BioPortfolio: 2014-07-23T21:13:32-0400
This is a randomized double-blind three-arm trial to evaluate two dosages of CVT-E002 against placebo in pediatric upper respiratory tract infections (URTI). It is hypothesized that CVT-E...
This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. The study will investigate the effect of daily intake of a...
The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tr...
This randomized pilot trial studies how well North American ginseng extract AFX-2 (ginseng) works in decreasing cancer-related fatigue after treatment in cancer survivors. Ginseng may decr...
The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger...
Acute upper respiratory tract infections (URTIs) and their complications are the most frequent cause of antibiotic prescribing in primary care. With multi-resistant organisms proliferating, appropr...
Despite being a bedside technique under rapid development and diffusion, lung ultrasound has not been often used in the management of viral low respiratory tract infections, although these infections ...
The FilmArray Respiratory Panel (FA-RP) is an FDA certified multiplex PCR that can detect 17 viruses and 3 bacteria responsible for upper respiratory tract infections, thus it is potentially useful to...
In patients affected by severe primary antibody deficiencies, H. influenzae and S. pneumoniae airways colonization is a risk factor for upper tract respiratory infections. Recent antibiotic usage infl...
New molecular methods have revealed frequent and often polymicrobial respiratory infections in children in low-income settings. It is not known whether presence of multiple pathogens is due to prolong...
A second-generation cephalosporin administered intravenously or intramuscularly. Its bactericidal action results from inhibition of cell wall synthesis. It is used for urinary tract infections, lower respiratory tract infections, and soft tissue and bone infections.
A species of gram-negative, anaerobic, rod-shaped bacteria isolated from the gingival margin and sulcus and from infections of the upper respiratory tract and pleural cavity.
A species in the genus CORONAVIRUS causing upper and lower RESPIRATORY TRACT INFECTIONS. It shares the receptor used by the SARS VIRUS.
A genus of the family PICORNAVIRIDAE infecting mainly cloven-hoofed animals. They cause vesicular lesions and upper respiratory tract infections. FOOT AND MOUTH DISEASE VIRUS is the type species.
Individual members of North American ethnic groups with ancient historic ancestral origins in Asia.
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs. They're usually caused by viruses, but they can also ...
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...