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