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

NCT ID: NCT03738917

Last Updated: 2022-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 668 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-12-31

Brief 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.

Detailed Description

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.

Conditions

Acute Bronchitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dextromethorphan

Usual clinical practice + dextromethorphan (15 milligrams unit), one 15 mg-tablet t.i.d. up to a maximum of 14 days.

Group Type: ACTIVE_COMPARATOR

Dextromethorphan 15 milligrams

Intervention Type: DRUG

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.

Ipratropium

Usual clinical practice + ipratropium bromide 20Micrograms Inhaler each puff), 2 puffs t.i.d. up to a maximum of 14 days.

Group Type: ACTIVE_COMPARATOR

Ipratropium Bromide 20Micrograms Inhaler

Intervention Type: DRUG

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.

Honey

Usual clinical practice + Honey 30 g (full tablespoon) t.i.d. up to a maximum of 14 days. Patients will be given two 750 milligram bottles of wildflower honey (the most frequent type of honey used in our country) and patients will be recommended to add the honey to a cup of lemon or thyme juice, milk herbal tea, yogurt, as a hot toddy, etc.

Group Type: ACTIVE_COMPARATOR

Honey 30 g (full tablespoon)

Intervention Type: DIETARY_SUPPLEMENT

This study product will be provided free to the participants by the sponsor.

Usual clinical practice

Usual care.

Group Type: PLACEBO_COMPARATOR

Usual clinical practice

Intervention Type: OTHER

Clinicians will not be allowed to prescribe antitussives, including codeine, anticholinergic inhalers and they will not be allowed to recommend the use of honey.

Interventions

Dextromethorphan 15 milligrams

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.

Intervention Type: DRUG

Ipratropium Bromide 20Micrograms Inhaler

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.

Intervention Type: DRUG

Honey 30 g (full tablespoon)

This study product will be provided free to the participants by the sponsor.

Intervention Type: DIETARY_SUPPLEMENT

Usual clinical practice

Clinicians will not be allowed to prescribe antitussives, including codeine, anticholinergic inhalers and they will not be allowed to recommend the use of honey.

Intervention Type: OTHER

Other Intervention Names

Antitussive; Anticholinergic; Dietary supplement; Usual care

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Clinical Research Network - SCReN

NETWORK

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Moragas, MD PhD

Role: STUDY_CHAIR

Catalan Institute of Health

Locations

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

Singuerlin Health Center

Santa Coloma de Gramenet, Catalonia, Spain

CAP Jaume I

Tarragona, Catalonia, Spain

Countries

Spain

References

Llor C, Moragas A, Ouchi D, Monfa R, Garcia-Sangenis A, Gomez-Lumbreras A, Pera H, Pujol J, Morros R. Effectiveness of antitussives, anticholinergics, and honey versus usual care in adults with uncomplicated acute bronchitis: a multiarm randomized clinical trial. Fam Pract. 2023 Mar 28;40(2):407-413. doi: 10.1093/fampra/cmac112.

Reference Type: DERIVED

PMID: 36239199 (View on PubMed)

Cots JM, Moragas A, Garcia-Sangenis A, Morros R, Gomez-Lumbreras A, Ouchi D, Monfa R, Pera H, Pujol J, Bayona C, de la Poza-Abad M, Llor C. Effectiveness of antitussives, anticholinergics or honey versus usual care in adults with uncomplicated acute bronchitis: a study protocol of an open randomised clinical trial in primary care. BMJ Open. 2019 May 16;9(5):e028159. doi: 10.1136/bmjopen-2018-028159.

Reference Type: DERIVED

PMID: 31101700 (View on PubMed)

Other Identifiers

IJG-AB4T-2018

Identifier Type: -

Identifier Source: org_study_id