Clinical trial NCT00940836: Efficacy and Safety Assessment of an Anti-Cold Preparation in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Common Cold
Flu-like Syndrome
Keywords: Anti-cold
Cold preparation
RCT
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2009-07-16
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Questionnaires were answered at baseline and 1st followup to the investigator and during treatment at every dose, 5 times a day, from day 1 to 3/4, through patient's diary.
Secondary outcomes:
measure: Global duration of symptoms, assessed by the investigator through direct questioning at followup visits.
timeFrame: Day 3/4 and, if no relief yet, day 10/11.
measure: Time of return to usual activities, such as work or gym, assessed by the investigator through direct questioning at followup visits.
timeFrame: Day 3/4 and, if no relief yet, day 10/11.
measure: Use of co intervention for symptom relief during treatment, registered by the volunteer in patient diary, with day and hour of ingestion.
timeFrame: Assessed during treatment (day 1 to 3/4) by patient diary and questioned by investigator at 1st followup visit.
measure: Improval of fever by reduction of axillary temperature to less than 38,1°C.
timeFrame: Assessed by investigator at baseline and 1st followup visit and by patient (with termometer provided by the study) along with every dose, 5 times a day, from day 1 to 3/4, registered in patient diary.
measure: 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.
timeFrame: Days 1 to 3/4 through patient diary, and followup at days 3/4 an 10/11.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
References: