Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Acute Bronchitis. (AB4T)
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| ClinicalTrials.gov Identifier: NCT03738917 |
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Recruitment Status :
Recruiting
First Posted : November 13, 2018
Last Update Posted : August 31, 2021
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Sponsor:
Jordi Gol i Gurina Foundation
Collaborator:
Spanish Clinical Research Network - SCReN
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Bronchitis | Drug: Dextromethorphan 15 milligrams Drug: Ipratropium Bromide 20Micrograms Inhaler Dietary Supplement: Honey 30 g (full tablespoon) Other: Usual clinical practice | Phase 4 |
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 (Clinical Trial) |
| Estimated Enrollment : | 668 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Multicentre, pragmatic, parallel group, open randomized trial. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Uncomplicated Acute Bronchitis. |
| Actual Study Start Date : | February 1, 2019 |
| Estimated Primary Completion Date : | November 30, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Dextromethorphan
Usual clinical practice + dextromethorphan (15 milligrams unit), one 15 mg-tablet t.i.d. up to a maximum of 14 days.
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Drug: 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.
Other Name: Antitussive |
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Active Comparator: Ipratropium
Usual clinical practice + ipratropium bromide 20Micrograms Inhaler each puff), 2 puffs t.i.d. up to a maximum of 14 days.
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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.
Other Name: Anticholinergic |
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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.
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Dietary Supplement: Honey 30 g (full tablespoon)
This study product will be provided free to the participants by the sponsor.
Other Name: Dietary supplement |
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Placebo Comparator: Usual clinical practice
Usual care.
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Other: 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.
Other Name: Usual care |
Primary Outcome Measures :
- 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).
Secondary Outcome Measures :
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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.
- 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.
- Number of days of absence from work in the four arms. [ Time Frame: Day 15. ]Electronic records and sick leave certifications.
- 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.
- 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.
- 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.
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738917
Contacts
| Contact: Carl Llor, MD PhD | 693696644 | carles.llor@gmail.com | |
| Contact: Ana Garcia-Sangenis, MD | 0034934824124 | agarcia@idiapjgol.org |
Locations
| Spain | |
| Nova Lloreda Health Center | Recruiting |
| Badalona, Catalonia, Spain, 08910 | |
| Contact: Maria Vila Royo, MD 0034934603900 mvila.cp.ics@gencat.cat | |
| Martí i Julià Health Center | Recruiting |
| Badalona, Catalonia, Spain, 08911 | |
| Contact: Miquel Morales Guerra 0034931671840 mmorales.cp.ics@gencat.cat | |
| Balaguer Health Center | Recruiting |
| Balaguer, Catalonia, Spain, 25600 | |
| Contact: Jesus Pujol, MD PhD 0034973447714 dr.indomable@gmail.com | |
| Via Roma Health Centre | Not yet recruiting |
| Barcelona, Catalonia, Spain, 08015 | |
| Contact: Carl Llor, MD PhD 693696644 ext 693696644 carles.llor@gmail.com | |
| La Marina Health Center | Recruiting |
| Barcelona, Catalonia, Spain, 08027 | |
| Contact: Josep M. Cots, MD PhD 0034601381364 23465jcy@comb.cat | |
| Contact: Carolina A Bayona, MD PhD 0034680612162 31217cbf@comb.cat | |
| CAP Passeig Maragall (EAP Camp de l'Arpa) | Recruiting |
| Barcelona, Catalonia, Spain, 08041 | |
| Contact: Maite Tierno Ortega, MD 934462950 mtierno@gencat.cat | |
| Cornellà - La Gavarra Health Center | Recruiting |
| Cornellà De Llobregat, Catalonia, Spain, 08940 | |
| Contact: Silvia Cobo Guerrero 0034933768250 scobo.cp.ics@gencat.cat | |
| Pineda de Mar Health Center | Recruiting |
| Pineda De Mar, Catalonia, Spain, 08397 | |
| Contact: Esperança Almerich Latorre, MD 0034937671560 ealmerich.bnm.ics@gencat.cat | |
| Ca n'OriacHealth Center | Recruiting |
| Sabadell, Catalonia, Spain, 08027 | |
| Contact: Olga Bigas Aguilera, MD 937233713 obigas.bcn.ics@gencat.cat | |
| Molí Nou Health Center | Recruiting |
| Sant Boi De Llobregat, Catalonia, Spain, 08830 | |
| Contact: Carles Alvarado Montesdeoca, MD 0034936543300 calvarado.cp.ics@gencat.cat | |
| Singuerlin Health Center | Recruiting |
| Santa Coloma De Gramenet, Catalonia, Spain, 08924 | |
| Contact: José Manuel Escudero Ibáñez, MD 0034934685800 jmescudero.bnm.ics@gencat.cat | |
| CAP Jaume I | Recruiting |
| Tarragona, Catalonia, Spain, 43005 | |
| Contact: Ana Moragas, MD PhD 0034600072170 anamaria.moragas@urv.cat | |
| Contact: Silvia Hernandez, MD PhD 607811649 silviaha@comt.es | |
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Spanish Clinical Research Network - SCReN
Investigators
| Study Chair: | Ana Moragas, MD PhD | Catalan Institute of Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jordi Gol i Gurina Foundation |
| ClinicalTrials.gov Identifier: | NCT03738917 |
| Other Study ID Numbers: |
IJG-AB4T-2018 |
| First Posted: | November 13, 2018 Key Record Dates |
| Last Update Posted: | August 31, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Reposition of data in Scientia |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | 2021 |
| Access Criteria: | Scientia |
| URL: | http://scientiasalut.gencat.cat |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Jordi Gol i Gurina Foundation:
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Cough; Dextromethorphan; Ipratropium; Honey. |
Additional relevant MeSH terms:
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Bronchitis Acute Disease Respiratory Tract Infections Infections Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Disease Attributes Pathologic Processes Bromides Dextromethorphan Ipratropium Cholinergic Antagonists |
Anticonvulsants Antitussive Agents Respiratory System Agents Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Cholinergic Agents |