Human Influenza
Conditions
Interventions
This is a randomized, controlled, multicenter, double-blind clinical trial with three treatment groups. A total of 330 participants who meet the eligibility criteria will be randomly assigned to an in
Sponsors
Scentryphar Pesquisa Clínica Ltda
Kley Hertz Farmacêutica S.A.
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients capable of understanding the nature of the study, willing to comply with all study procedures, and who agree to provide signed informed consent; Male or female, aged greater than or equal to 18 years and less than or equal to 65 years at the time of signing the informed consent; Patients must have a cold or flu-like illness diagnosed by a healthcare professional at the study center, with the following symptoms having started within 72 hours before the screening/baseline visit: nasal congestion, sneezing, and runny nose. The severity of general nasal symptoms must be at least moderate on a five-point Likert-type symptom severity scale (0 = no symptoms; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe); Patients must also have non-nasal cold symptoms (sore throat, headache, cough, myalgia, and fever). The severity of pain symptoms must be at least moderate on a five-point Likert-type symptom severity scale (0 = no symptoms; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe); Patients must have a sum of physician assessment of signs scores of at least 5
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women (lactating women); Women who do not agree to use temporary contraceptive methods; Men who do not agree to use temporary contraceptive methods (considering the short treatment time of this study), such as barrier methods, during the study, except for those who are surgically sterile (vasectomy), or who have female partners who use effective contraceptive methods, or surgically sterile partners, or partners who have been menopausal for at least 1 (one) year, or participants who declare that they do not engage in sexual practices or engage in them in a non-reproductive manner; History of or known hypersensitivity to any of the study medications, excipients, or medications of similar chemical classes; Rapid onset of symptoms that, in the investigator's opinion, are indicative of severe cases of influenza; Use of alcohol or illicit drugs; Use of monoamine oxidase (MAO) inhibitors or barbiturates; Perennial or seasonal allergic rhinitis confirmed at screening; History of or chronic respiratory disease (within the past 5 years); Presence of nasal polyps, significant nasal septum deviation, or any other anatomical abnormality affecting airflow; Any current acute illness or uncontrolled exacerbation of a chronic disease; Any evidence (within 2 years) of significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematologic, endocrinologic, metabolic, neurologic, psychiatric, or other disease at screening, including hypertension, cardiac arrhythmias, serious organic changes of the heart and blood vessels, uncontrolled thyroid disease, thyrotoxicosis, decompensated diabetes, or benign prostatic hypertrophy, based on the investigators' assessment; Long QT syndrome or QTc greater than 450 msec for men and greater than 470 msec for women at screening/baseline; Clinical evidence of immunosuppression; Clinically relevant chronic or acute infectious diseases or febrile infections within 2 weeks prior to study entry, including bacterial sinusitis within 2 weeks prior to the screening visit/baseline period; Influenza vaccination up to 1 week prior to enrollment; Need for antiviral therapy to treat influenza A or B infection; Need for antibacterial therapy to treat acute respiratory infection; Use of medication to treat conditions acquired prior to enrollment for a period shorter than two time intervals of administration of these medications; Patients using medications likely to interact with phenylephrine and chlorpheniramine (alcohol, opioid analgesics, anticonvulsants, antidepressants (tricyclic monoamine oxidase inhibitors), antihistamines, antiemetics, antipsychotics, anxiolytics and hypnotics, alpha and beta blockers, vasodilators, sympathomimetic agents) and paracetamol (for paracetamol alone: ??within 24 hours before study drug intake and during the study, also anticoagulants such as warfarin and coumarin, chloramphenicol, probenecid, rifampicin and isoniazid, cholestyramine, metoclopramide, domperidone, zidovudine, didanosine, propantheline) should be excluded; Use of another investigational drug in the period less than one year before enrollment; Any other changes in laboratory tests regarding complete blood count, blood glucose (pre- or postprandial), sodium, potassium, creatinine, total bilirubin, AST, AST, alkaline phosphatase, and ?-GT, which, in the investigator's discretion, are considered clinically significant; Patient reports consumption of any drug-metabolizing enzyme (e.g., C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in the intensity of nasal congestion and runny nose symptoms is expected, assessed using ordinal categorical scales with scores from 0 to 4, defined as: 0 – absent; 1 – mild; 2 – moderate; 3 – intense; and 4 – very intense. A clinical response will be considered a minimum reduction of one point in the scale score for both nasal symptoms after 72 hours of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in the overall score of nasal symptoms (nasal congestion, runny nose, sneezing, tearing, and itching) and extra-nasal symptoms (sore throat, headache, cough, muscle pain, and fever) is expected, assessed using ordinal categorical scales with scores from 0 to 4, defined as: 0 – absent; 1 – mild; 2 – moderate; 3 – intense; and 4 – very intense. The overall score will be calculated by summing the individual scores for each symptom. A clinical response will be considered a minimum reduction of one point in the overall score after 72 hours of treatment.;A reduction in the clinical score of upper airway compromise is expected, assessed by summing the scores related to turbinate color and edema, presence of secretion, and pharyngeal inflammation, using ordinal categorical scales with scores from 0 to 4, defined as: 0 – absent; 1 – mild; 2 – moderate; 3 – severe; and 4 – very severe. A clinical response will be considered a minimum reduction of one point in the overall score after 72 hours of treatment. | — |
Countries
Brazil
Contacts
Public ContactKley Hertz Farmacêutica S.A.
Kley Hertz Farmacêutica S.A.
Outcome results
None listed