Overview

Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Acute Bronchitis.

Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jordi Gol i Gurina Foundation
Collaborators:
Spanish Clinical Research Network - CAIBER
Spanish Clinical Research Network - SCReN
Treatments:
Antitussive Agents
Bromides
Chlorpheniramine, phenylpropanolamine drug combination
Cholinergic Antagonists
Dextromethorphan
Guaifenesin
Ipratropium
Phenylpropanolamine
Criteria
Inclusion Criteria:

- age 18 years or older, and

- symptoms of acute bronchitis with cough starting within 3 weeks before study
inclusion, and

- patients who score ≥ 4 in either the daytime and/or nocturnal cough on a 7-point
Likert scale, and

- patients who consent to participate.

Exclusion Criteria:

- suspected pneumonia; if the professional suspects pneumonia, a chest X-ray will be
recommended and the patient will be randomized if this diagnosis is discarded; or

- criteria for hospital admission (impaired consciousness, respiratory rate > 30
breaths/minute, pulse > 125 beats/minute, systolic blood pressure <90 mm Hg or
diastolic blood pressure <60 mm Hg, temperature > 104°F or oxygen saturation <92%)

- pregnancy or breast feeding

- baseline respiratory disease such as chronic obstructive pulmonary disease, asthma,
tuberculosis or bronchiectasis

- associated significant comorbidity, such as moderate-severe heart failure, dementia,
acute myocardial infarction/recent cerebral vascular accident (< 3 months), severe
liver failure, severe renal failure

- immunosuppression, such as chronic infection by HIV, transplanted, neutropenic, or
patients receiving immunosuppressive treatment

- active neoplasm

- terminal illness

- history of intolerance or allergy to any of the study treatments

- patients in whom, in the opinion of the investigator, treatment with dextromethorphan,
ipratropium bromide or honey is contraindicated

- patients living in long-term institutions

- difficulty in conducting scheduled follow-up visits