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

NCT03738917 | Completed Phase 4 DMC

• 1 other identifier: IJG-AB4T-2018
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 12

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.

Conditions

Acute Bronchitis

Keywords

Cough; Dextromethorphan; Ipratropium; Honey.

Outcome Measures

Primary Outcomes (1)

• Duration of moderate-severe cough in days in the four arms.

  Number of days until the last day the patient scores 3 in either daytime cough or nocturnal cough in the symptom diary. Each symptom will be scored by the patient on a 7-point Likert scale, which has been used in previous studies (0=not affected; 1=very little problem; 2=slight problem; 3=moderately bad; 4=bad; 5=very bad; 6=as bad as it could be).

  Day 29.

Secondary Outcomes (13)

• Duration of cough in days in the four arms.

  Days 15 and 29. If the patient continues to score 2 or more at day 29 will be called at day 43.

• Duration of moderate-severe daytime cough in days in the four arms.

  Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.

• Duration of moderate-severe nocturnal cough in days in the four arms.

  Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.

• Duration of moderate-severe symptoms in days in the four arms.

  Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.

• Duration of severe symptoms in days in the four arms.

  Days 15 and 29.

Study Arms (4)

Dextromethorphan

ACTIVE COMPARATOR

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

Drug: Dextromethorphan 15 milligrams

Ipratropium

ACTIVE COMPARATOR

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

Drug: Ipratropium Bromide 20Micrograms Inhaler

Honey

ACTIVE COMPARATOR

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.

Dietary Supplement: Honey 30 g (full tablespoon)

Usual clinical practice

PLACEBO COMPARATOR

Usual care.

Other: Usual clinical practice

Interventions

Dextromethorphan 15 milligrams 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.

Also known as: Antitussive

Dextromethorphan

Ipratropium Bromide 20Micrograms Inhaler 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.

Also known as: Anticholinergic

Ipratropium

Honey 30 g (full tablespoon) DIETARY_SUPPLEMENT

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

Also known as: Dietary supplement

Honey

Usual clinical practice 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.

Also known as: Usual care

Usual clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older, 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Spanish Clinical Research Network - SCReN: collaborator

Study Sites (12)

Nova Lloreda Health Center

Badalona, Catalonia, 08910, Spain

Location

Martí i Julià Health Center

Badalona, Catalonia, 08911, Spain

Location

Balaguer Health Center

Balaguer, Catalonia, 25600, Spain

Location

Via Roma Health Centre

Barcelona, Catalonia, 08015, Spain

Location

La Marina Health Center

Barcelona, Catalonia, 08027, Spain

Location

CAP Passeig Maragall (EAP Camp de l'Arpa)

Barcelona, Catalonia, 08041, Spain

Location

Cornellà - La Gavarra Health Center

Cornellà de Llobregat, Catalonia, 08940, Spain

Location

Pineda de Mar Health Center

Pineda de Mar, Catalonia, 08397, Spain

Location

Ca n'OriacHealth Center

Sabadell, Catalonia, 08027, Spain

Location

Molí Nou Health Center

Sant Boi de Llobregat, Catalonia, 08830, Spain

Location

Singuerlin Health Center

Santa Coloma de Gramenet, Catalonia, 08924, Spain

Location

CAP Jaume I

Tarragona, Catalonia, 43005, Spain

Location

Related Publications (2)

• 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.

  PMID: 36239199 DERIVED

• 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.

  PMID: 31101700 DERIVED

MeSH Terms

Conditions

Bronchitis; Cough

Interventions

Antitussive Agents; Cholinergic Antagonists; Honey; Dietary Supplements

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Respiratory System Agents; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ana Moragas, MD PhD

  Catalan Institute of Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, pragmatic, parallel group, open randomized trial.

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 13, 2018
• Study Start: February 1, 2019
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: August 30, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2021
• Access Criteria: Scientia

Locations

ES (12)