Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Acute … (NCT03738917) | Clinical Trial Compass
CompletedPhase 4
Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Acute Bronchitis.
Spain668 participantsStarted 2019-02-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
* diffi…
What they're measuring
1
Duration of moderate-severe cough in days in the four arms.
Timeframe: Day 29.
Trial details
NCT IDNCT03738917
SponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina