This study, which is aimed at comparing the effectiveness of 3 symptomatic therapies (dextromethorphan, ipratropium and honey) associated with usual care and the usual care in adults with acute bronchitis, is a multicentre, pragmatic, parallel group, open randomised trial. Patients aged 18 or over with uncomplicated acute bronchitis, with cough \<3 weeks as the main symptom, scoring ≥ 4 in either daytime or nocturnal cough on a 7-point Likert scale, will be randomised to one of the 4 groups. Sample: 668 patients. The primary outcome will be the number of days with moderate-severe cough.
Despite the frequent use of therapies in acute bronchitis, encouraged by the over-the-counter availability in pharmacies, the evidence of their benefit is scarce, since only a few clinical trials have been published, with low sample sizes, poor methodological quality and mainly in children. The objective of this study is to compare the effectiveness of 3 symptomatic therapies (dextromethorphan, ipratropium and honey) associated with usual care and the usual care in adults with acute bronchitis. This will be a multicentre, pragmatic, parallel group, open randomised trial. Patients aged 18 or over with uncomplicated acute bronchitis, with cough for less than three weeks as the main symptom, scoring ≥ 4 in either daytime or nocturnal cough on a 7-point Likert scale, will be randomised to one of the following four groups: usual care, usual care + dextromethorphan 30 mg t.i.d., usual care + ipratropium bromide inhaler 20 µg 2 puffs t.i.d, or usual care + 30 mg (a spoonful) of honey t.i.d., all taken for up to 14 days. The exclusion criteria will be: pneumonia, criteria for hospital admission, pregnancy or lactation, concomitant pulmonary disease, associated significant comorbidity, allergy, intolerance or contraindication to any of the study drugs, admitted to a long-term residence, or inability to give informed consent. Sample: 668 patients. The primary outcome will be the number of days with moderate-severe cough in the intention-to-treat (ITT) population, i.e., the number of days from the randomisation visit until the last day the patient scores three or more in either daytime or nocturnal cough in the symptom diary. All patients will be given a symptom diary to be self-administered while symptoms are present. A second visit will be scheduled at day 2-3 for assessing evolution, with two more visits at days 15 and 29 for clinical assessment, evaluation of adverse effects, re-attendance and complications. Patients still with symptoms at day 29 will be called six weeks after the baseline visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
668
This drug is already marketed, and therefore, the manufacturer is responsible for the elaboration and control of samples. This study drug will be provided free to the participants by the sponsor.
This drug is already marketed, and therefore, the manufacturer is responsible for the elaboration and control of samples. This study drug will be provided free to the participants by the sponsor.
This study product will be provided free to the participants by the sponsor.
Clinicians will not be allowed to prescribe antitussives, including codeine, anticholinergic inhalers and they will not be allowed to recommend the use of honey.
Nova Lloreda Health Center
Badalona, Catalonia, Spain
Martí i Julià Health Center
Badalona, Catalonia, Spain
Balaguer Health Center
Balaguer, Catalonia, Spain
Via Roma Health Centre
Barcelona, Catalonia, Spain
La Marina Health Center
Barcelona, Catalonia, Spain
CAP Passeig Maragall (EAP Camp de l'Arpa)
Barcelona, Catalonia, Spain
Cornellà - La Gavarra Health Center
Cornellà de Llobregat, Catalonia, Spain
Pineda de Mar Health Center
Pineda de Mar, Catalonia, Spain
Ca n'OriacHealth Center
Sabadell, Catalonia, Spain
Molí Nou Health Center
Sant Boi de Llobregat, Catalonia, Spain
...and 2 more locations
Duration of moderate-severe cough in days in the four arms.
Number of days until the last day the patient scores 3 in either daytime cough or nocturnal cough in the symptom diary. Each symptom will be scored by the patient on a 7-point Likert scale, which has been used in previous studies (0=not affected; 1=very little problem; 2=slight problem; 3=moderately bad; 4=bad; 5=very bad; 6=as bad as it could be).
Time frame: Day 29.
Duration of cough in days in the four arms.
Number of days until the last day the patient scores 2 in either daytime cough or nocturnal cough in the symptom diary. Each symptom will be scored by the patient on a 7-point Likert scale, which has been used in previous studies (0=not affected; 1=very little problem; 2=slight problem; 3=moderately bad; 4=bad; 5=very bad; 6=as bad as it could be).
Time frame: Days 15 and 29. If the patient continues to score 2 or more at day 29 will be called at day 43.
Duration of moderate-severe daytime cough in days in the four arms.
Number of days until the last day the patient scores 3 in daytime cough in the symptom diary. This symptom will be scored by the patient on a 7-point Likert scale, which has been used in previous studies (0=not affected; 1=very little problem; 2=slight problem; 3=moderately bad; 4=bad; 5=very bad; 6=as bad as it could be).
Time frame: Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.
Duration of moderate-severe nocturnal cough in days in the four arms.
Number of days until the last day the patient scores 3 in nocturnal cough in the symptom diary. This symptom will be scored by the patient on a 7-point Likert scale, which has been used in previous studies (0=not affected; 1=very little problem; 2=slight problem; 3=moderately bad; 4=bad; 5=very bad; 6=as bad as it could be).
Time frame: Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.
Duration of moderate-severe symptoms in days in the four arms.
Number of days until the last day the patient scores 3 in any of the symptoms in the symptom diary. Each symptom will be scored by the patient on a 7-point Likert scale, which has been used in previous studies (0=not affected; 1=very little problem; 2=slight problem; 3=moderately bad; 4=bad; 5=very bad; 6=as bad as it could be).
Time frame: Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.
Duration of severe symptoms in days in the four arms.
Number of days until the last day the patient scores 5 in any of the symptoms in the symptom diary. Each symptom will be scored by the patient on a 7-point Likert scale, which has been used in previous studies (0=not affected; 1=very little problem; 2=slight problem; 3=moderately bad; 4=bad; 5=very bad; 6=as bad as it could be).
Time frame: Days 15 and 29.
Duration of symptoms in days in the four arms.
Number of days until the last day the patient scores 2 in any of the symptoms in the symptom diary. Each symptom will be scored by the patient on a 7-point Likert scale, which has been used in previous studies (0=not affected; 1=very little problem; 2=slight problem; 3=moderately bad; 4=bad; 5=very bad; 6=as bad as it could be).
Time frame: Days 15 and 29. If the patient continues to score 2 or more at day 29 will be called at day 43.
Duration of moderate-severe cough in days according to the basal degree of bronchial hyper-reactiveness in the four arms.
Number of days until the last day the patient scores 3 in either daytime cough or nocturnal cough in the symptom diary. Each symptom will be scored by the patient on a 7-point Likert scale, which has been used in previous studies (0=not affected; 1=very little problem; 2=slight problem; 3=moderately bad; 4=bad; 5=very bad; 6=as bad as it could be). Bronchial hyper-responsiveness will be determined with three peak-flow measurements at day 1 and the highest of three peak flow measurements will be collected.
Time frame: The peak-flow will be determined at day 1.
Percentage of antibiotics and different symptomatic treatments used in the four arms.
This information will be collected every day by the patients themselves.
Time frame: Days 2-4, 15 and 29.
Number of days of absence from work in the four arms.
Electronic records and sick leave certifications.
Time frame: Day 15.
Patients re-attendance for symptoms related to the episode of acute bronchitis within the first 42 days.
The number of re-attendances to any doctor regarding the episode of acute bronchitis will be collected from the electronic records.
Time frame: Day 29 and phone call at day 43.
Number of complications related to the episode of acute bronchitis within the first 28-42 days.
The number of complications will be collected through electronic records and hospital certifications.
Time frame: Day 29-43.
Patient satisfaction in the four arms.
Patient satisfaction will be collected in the same symptom diaries by the patients themselves by means of questions included in the symptom diary.
Time frame: Day 15 or 29.
Number of adverse events in the four arms.
The number of adverse events will be collected by the participating doctor by means of questions.
Time frame: Days 2-4, 15 and 29.
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