- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03738917
Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Acute Bronchitis. (AB4T)
August 29, 2022 updated by: Jordi Gol i Gurina Foundation
Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Uncomplicated Acute Bronchitis.
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
668
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Catalonia
-
Badalona, Catalonia, Spain, 08910
- Nova Lloreda Health Center
-
Badalona, Catalonia, Spain, 08911
- Martí i Julià Health Center
-
Balaguer, Catalonia, Spain, 25600
- Balaguer Health Center
-
Barcelona, Catalonia, Spain, 08015
- Via Roma Health Centre
-
Barcelona, Catalonia, Spain, 08027
- La Marina Health Center
-
Barcelona, Catalonia, Spain, 08041
- CAP Passeig Maragall (EAP Camp de l'Arpa)
-
Cornellà De Llobregat, Catalonia, Spain, 08940
- Cornellà - La Gavarra Health Center
-
Pineda De Mar, Catalonia, Spain, 08397
- Pineda de Mar Health Center
-
Sabadell, Catalonia, Spain, 08027
- Ca n'OriacHealth Center
-
Sant Boi De Llobregat, Catalonia, Spain, 08830
- Molí Nou Health Center
-
Santa Coloma De Gramenet, Catalonia, Spain, 08924
- Singuerlin Health Center
-
Tarragona, Catalonia, Spain, 43005
- CAP Jaume I
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dextromethorphan
Usual clinical practice + dextromethorphan (15 milligrams unit), one 15 mg-tablet t.i.d. up to a maximum of 14 days.
|
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.
Other Names:
|
Active Comparator: Ipratropium
Usual clinical practice + ipratropium bromide 20Micrograms Inhaler each puff), 2 puffs t.i.d. up to a maximum of 14 days.
|
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.
Other Names:
|
Active Comparator: 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.
|
This study product will be provided free to the participants by the sponsor.
Other Names:
|
Placebo Comparator: Usual clinical practice
Usual care.
|
Clinicians will not be allowed to prescribe antitussives, including codeine, anticholinergic inhalers and they will not be allowed to recommend the use of honey.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of moderate-severe cough in days in the four arms.
Time Frame: Day 29.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of cough in days in the four arms.
Time Frame: Days 15 and 29. If the patient continues to score 2 or more at day 29 will be called at day 43.
|
Number of days until the last day the patient scores 2 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).
|
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.
Time Frame: Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.
|
Number of days until the last day the patient scores 3 in daytime cough in the symptom diary.
This 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).
|
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.
Time Frame: Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.
|
Number of days until the last day the patient scores 3 in nocturnal cough in the symptom diary.
This 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).
|
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.
Time Frame: Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.
|
Number of days until the last day the patient scores 3 in any of the symptoms 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).
|
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.
Time Frame: Days 15 and 29.
|
Number of days until the last day the patient scores 5 in any of the symptoms 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).
|
Days 15 and 29.
|
Duration of symptoms in days in the four arms.
Time Frame: Days 15 and 29. If the patient continues to score 2 or more at day 29 will be called at day 43.
|
Number of days until the last day the patient scores 2 in any of the symptoms 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).
|
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 cough in days according to the basal degree of bronchial hyper-reactiveness in the four arms.
Time Frame: The peak-flow will be determined at day 1.
|
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).
Bronchial hyper-responsiveness will be determined with three peak-flow measurements at day 1 and the highest of three peak flow measurements will be collected.
|
The peak-flow will be determined at day 1.
|
Percentage of antibiotics and different symptomatic treatments used in the four arms.
Time Frame: Days 2-4, 15 and 29.
|
This information will be collected every day by the patients themselves.
|
Days 2-4, 15 and 29.
|
Number of days of absence from work in the four arms.
Time Frame: Day 15.
|
Electronic records and sick leave certifications.
|
Day 15.
|
Patients re-attendance for symptoms related to the episode of acute bronchitis within the first 42 days.
Time Frame: Day 29 and phone call at day 43.
|
The number of re-attendances to any doctor regarding the episode of acute bronchitis will be collected from the electronic records.
|
Day 29 and phone call at day 43.
|
Number of complications related to the episode of acute bronchitis within the first 28-42 days.
Time Frame: Day 29-43.
|
The number of complications will be collected through electronic records and hospital certifications.
|
Day 29-43.
|
Patient satisfaction in the four arms.
Time Frame: Day 15 or 29.
|
Patient satisfaction will be collected in the same symptom diaries by the patients themselves by means of questions included in the symptom diary.
|
Day 15 or 29.
|
Number of adverse events in the four arms.
Time Frame: Days 2-4, 15 and 29.
|
The number of adverse events will be collected by the participating doctor by means of questions.
|
Days 2-4, 15 and 29.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Ana Moragas, MD PhD, Catalan Institute of Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. 2022 Oct 14:cmac112. doi: 10.1093/fampra/cmac112. Online ahead of print.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
November 30, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
November 5, 2018
First Submitted That Met QC Criteria
November 8, 2018
First Posted (Actual)
November 13, 2018
Study Record Updates
Last Update Posted (Actual)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 29, 2022
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Bronchial Diseases
- Lung Diseases, Obstructive
- Acute Disease
- Bronchitis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antitussive Agents
- Dextromethorphan
- Bromides
- Ipratropium
- Cholinergic Antagonists
Other Study ID Numbers
- IJG-AB4T-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Reposition of data in Scientia
IPD Sharing Time Frame
2021
IPD Sharing Access Criteria
Scientia
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Bronchitis
-
Hanlim Pharm. Co., Ltd.CompletedAcute Exacerbations of Chronic Bronchitis | Acute BronchitisKorea, Republic of
-
Jiangxi Qingfeng Pharmaceutical Co. Ltd.Not yet recruiting
-
Yuhan CorporationCompletedChronic Bronchitis | Acute BronchitisKorea, Republic of
-
Jiangxi Qingfeng Pharmaceutical Co. Ltd.UnknownAcute Exacerbation of Chronic BronchitisChina
-
PharmaKingCompletedAcute Exacerbation of Chronic BronchitisKorea, Republic of
-
AbbottCompletedAcute Bacterial Exacerbation of Chronic Bronchitis (ABECB).United States, Canada, Puerto Rico
-
Technische Universität DresdenUnknownAcute Wheezy Bronchitis | Recurrent BronchitisGermany
-
Hospital Universitari Vall d'Hebron Research InstituteCompletedAcute Bronchitis | Upper Respiratory Tract Infection | Acute BronchiolitisSpain
-
Northumbria Healthcare NHS Foundation TrustNewcastle-upon-Tyne Hospitals NHS Trust; National Institute for Health Research... and other collaboratorsCompletedPulmonary Disease, Chronic Obstructive | Emphysema | Chronic Bronchitis | Pulmonary Disease, Obstructive | Chronic Bronchitis With Airways Obstruction | Chronic Bronchitis With Acute ExacerbationUnited Kingdom
-
Parc de Salut MarCompletedObstructive Chronic Bronchitis With Acute ExacerbationSpain
Clinical Trials on Dextromethorphan 15 milligrams
-
PfizerActive, not recruitingTransthyretin Amyloid CardiomyopathyKorea, Republic of
-
University of Roma La SapienzaNot yet recruiting
-
Mayo ClinicCompleted
-
Neuralstem Inc.Unknown
-
Boehringer IngelheimCompleted
-
University Hospital, Strasbourg, FranceCompletedSurgical Intervention | MinorFrance
-
PfizerCompletedHealthy VolunteersBelgium
-
University of MiamiUnited States Department of DefenseRecruitingInfertility, MaleUnited States
-
National Cancer Institute (NCI)CompletedHead and Neck Squamous Cell Carcinoma | Recurrent Head and Neck Carcinoma | Recurrent Renal Cell Carcinoma | Recurrent Skin Carcinoma | Stage III Renal Cell Cancer | Stage IV Cutaneous Melanoma AJCC v6 and v7 | Recurrent Non-Small Cell Lung Carcinoma | Stage IIIC Cutaneous Melanoma AJCC v7 | Stage IV... and other conditionsUnited States