Effectiveness of antitussive, anticholinergic and honey therapy versus usual practice in adults with uncomplicated acute bronchitis [AB4T study]

Phase 1

• Conditions: Cough in the context of acute bronchitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; MedDRA version: 20.0Level: PTClassification code 10006451Term: BronchitisSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2018-002563-25-ES
• Lead Sponsor: IDIAP Jordi Gol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-10
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 668

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified