Efficacy and Safety Assessment of an Anti-Cold Preparation in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome

Condition(s) targeted: Common Cold; Flu-like Syndrome

Intervention: Resfenol (Drug); Placebo (Drug); Co interventional acetaminophen (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hospital de Clinicas de Porto Alegre

Overall contact:
Paulo D Picon, MD, PhD, Phone: 55 xx 51 33598752, Email: paulopicon@gmail.com

The aim of this study is to assess the efficacy and safety of an anti-cold preparation compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.

Official title: Phase III Clinical Trial - Efficacy and Safety Assessment of a Compound Acetaminophen, Chlorpheniramine and Phenylephrine Combination in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome in Adults

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Symptom improval assessed by questionnaires concerning headache, muscle ache, rhinorrhea, nasal obstruction, sneezes, cough, sore or irritated throat, hoarseness and fever, rated by patient himself in a scale from 0 to 4, being 0-absence and 4-severe.

Secondary outcome:

Global duration of symptoms, assessed by the investigator through direct questioning at followup visits.

Time of return to usual activities, such as work or gym, assessed by the investigator through direct questioning at followup visits.

Use of co intervention for symptom relief during treatment, registered by the volunteer in patient diary, with day and hour of ingestion.

Improval of fever by reduction of axillary temperature to less than 38,1°C.

Adverse effect appearance during and until 7 days after treatment, assessed through patient's report in the diary or followup visit, through physical evaluation at followup and by laboratory exams.

Detailed description: Upper respiratory infections are rather frequent in the population, and their treatment consists, in most cases, in the use of symptomatic drugs. Acetaminophen is widely used as an analgesic and antipyretic, whereas chlorpheniramine is an antihistaminic and phenylephrine is a vasoconstrictor with decongestioning activity. The aim of this study is to assess the efficacy and safety of an anti-cold preparation, currently commercialized in Brazil by the name Resfenol, compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.

Healthy volunteers are recruited through panels fixated at Hospital de Clínicas de Porto Alegre, in Brazil, and must answer a screening questionnaire at first contact. One hundred and forty six patients who met the inclusion criteria were included and, after baseline clinical and laboratory evaluation, were randomized to receive either the active intervention or placebo, 5 times a day, at 4 hour intervals, during 48 to 72 hours, depending on patient availability to show up for re-evaluation. Patients also received acetaminophen as a co intervention, to be taken only in case of persisting symptoms.

Patients answered, during treatment, several symptom questionnaires contained in a diary, and followup was performed at days 3 or 4 (clinical and laboratory evaluation) and 10 or 11 (clinical followup). Axillary temperature was assessed along with every dose with a thermometer provided by the study and registered in the diary.

Primary endpoint consists in the mean symptom scores, assessed through questionnaires in patient diary, baseline and followup. Secondary endpoints are global duration of symptoms, time of return to usual activities, use of co intervention for symptom relief, improval of fever and adverse effect evaluation.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age between 18 to 60 years old;

- Presenting with at least 6 and at max 72 hours of common cold symptoms (headache,

muscle ache, rhinorrhea, nasal obstruction, sneezing, cough, sore or irritated throat, hoarseness, fever) or flu-like syndrome (high fever, muscle or articular ache, headache), with at least two symptoms rated by the patient as moderated to severe in an 0 to 4 scale;

- Proper anticonception, in the case of women in fertile age;

- Possibility to abstain from using any other drug for the treatment of the studied

condition, except in emergencies, in wich case the responsible party must be immediately notified;

- Cooperation and understanding skills;

- Agreement to informed consent form.

Exclusion Criteria:

- Pregnant or lactating women;

- Hypersensitivity to any of the drug's components;

- Alcohol or substance abuse;

- Use of MAO inhibitor or barbituric;

- Diagnosis of any acute disease in current activity or uncontrolled chronic disease;

- Clinical evidence of immunosuppression;

- Influenza vaccine less than a week prior to inclusion;

- Need for antibiotic treatment for the respiratory infection, in the opinion of the

investigator;

- Having participated in other clinical trial less than one year prior to inclusion.

Paulo D Picon, MD, PhD, Phone: 55 xx 51 33598752, Email: paulopicon@gmail.com

Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul 90035-903, Brazil; Recruiting
Paulo D Picon, MD, PhD, Principal Investigator
Indara C Saccilotto, Administration, Sub-Investigator
Jorge A Szymanski, Medicine, Sub-Investigator
Marisa B Costa, Pharmacy, Sub-Investigator
Lúcia C Fendt, Med Student, Sub-Investigator
Mauricio L Suksteris, Med Student, Sub-Investigator
Alicia D Dornelles, Med Student, Sub-Investigator
Carolina R Barone, Med Student, Sub-Investigator
Loise P Smaniotto, Med Student, Sub-Investigator
Juliana Azambuja, Med Student, Sub-Investigator
Juliana F Zampieri, Med Student, Sub-Investigator

Starting date: June 2009
Last updated: July 15, 2009