Cough in the context of acute bronchitis MedDRA version: 20.0 Level: PT Classification code 10006451 Term: Bronchitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Dextrometorfano
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE
Other descriptive name: dextrometorfano
Concentration unit: mg milligram(s)
Concentration t
Sponsors
IDIAP Jordi Gol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged 18 years or older, who come to the primary care physician with cough of up to 3 weeks of evolution in the context of acute bronchitis and who agree to participate in the clinical trial. - Patients who score =4 in daytime and / or nighttime on the Likert scale of 6 points. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 508 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
Exclusion criteria: - Suspected pneumonia. - Patient with criteria for hospital referral - Pregnancy or lactation. - Basic respiratory disease: chronic obstructive pulmonary disease, asthma, tuberculosis or bronchiectasis. - Associated significant comorbility: moderate-severe heart failure, dementia, acute myocardial infarction / recent stroke (<3 months), severe hepatic insufficiency, severe renal insufficiency. - Immunosuppression. - Active neoplasia - Terminal disease - History of intolerance or allergy to any of the study treatments. - Patients in whom, in the opinion of the researcher, treatment with dextromethorphan, ipratropium bromide or honey is contraindicated. - Institutionalized patients. - Difficulty making scheduled follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the clinical effectiveness of adding 3 symptomatic treatments to the usual practice compared to the usual clinical practice in: - The reduction of days until resolution of acute bronchitis - Reduction of days with moderate-severe diurnal cough - The reduction of days with moderate-severe nighttime cough - Duration in days of cough - The duration in days of severe symptoms - The duration in days of severe or moderate symptoms - According to the basal degree of bronchial hyperreactivity quantified by peak-flow - The use of antibiotics and different symptomatic treatments - The number of days of absenteeism - The number of times the patient returns to consult - The number of complications - Patient satisfaction Evaluate the adverse reactions in each of the test strategies;Main Objective: To evaluate the clinical effectiveness of adding 3 symptomatic treatments (dextromethorphan, ipratropium bromide or honey) to normal practice in the reduction of days with moderate-severe cough compared with usual practice;Primary end point(s): Day reduction in the duration of moderate-severe cough;Timepoint(s) of evaluation of this end point: Daily evaluation by the patient's diary, which is collected in the face-to-face visit on day 15 and, if necessary, on the 29th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration in days of: - symptomatology - moderate-severe diurnal cough - moderate-severe nighttime cough - cough - severe symptoms - severe or moderate symptoms Bronchial hyperreactivity degree difference Use of antibiotics and other symptomatic treatments Number of days of absenteeism Number of times the patient returns to consult Number of complications Degree of satisfaction Number of adverse reactions;Timepoint(s) of evaluation of this end point: The variables evaluated by reduction in days will be collected daily by the patient in the symptom diary, of 14 days and, if necessary, 28 days. The researcher will collect and review the diary in the face-to-face visits of the 15th and 29th. Difference degree bronchial hyperreactivity: day 15 Use of antibiotics and other symptomatic treatments: day 15 and day 29 Number of days of work absenteeism: day 15 Number of times the patient returns to consult: day 29 and call day 42 Number of complications: day 29 and call day 42 Degree of satisfaction: day 15 or day 29 Number of adverse reactions: day 15 and day 29 | — |
Countries
Spain
Contacts
Public ContactUnitat Estudis Medicament
IDIAP Jordi Gol
Outcome results
None listed