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Acute BronchitisPhase 4AB4TNCT03738917

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

A Phase 4 study testing Dextromethorphan 15 milligrams, Ipratropium Bromide 20Micrograms Inhaler and Honey 30 g (full tablespoon) in people with Acute Bronchitis, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 12 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Bronchitis
What is being tested?
Dextromethorphan 15 milligrams, Ipratropium Bromide 20Micrograms Inhaler and Honey 30 g (full tablespoon)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
668 participants
Where
12 sitesSpain
Study dates
1 Feb 2019to 31 Dec 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Spain12 sites

  • Nova Lloreda Health Center

    Badalona, Catalonia, 08910

  • Martí i Julià Health Center

    Badalona, Catalonia, 08911

  • Balaguer Health Center

    Balaguer, Catalonia, 25600

  • Via Roma Health Centre

    Barcelona, Catalonia, 08015

  • La Marina Health Center

    Barcelona, Catalonia, 08027

  • CAP Passeig Maragall (EAP Camp de l'Arpa)

    Barcelona, Catalonia, 08041

  • Cornellà - La Gavarra Health Center

    Cornellà de Llobregat, Catalonia, 08940

  • Pineda de Mar Health Center

    Pineda de Mar, Catalonia, 08397

  • Ca n'OriacHealth Center

    Sabadell, Catalonia, 08027

  • Molí Nou Health Center

    Sant Boi de Llobregat, Catalonia, 08830

  • Singuerlin Health Center

    Santa Coloma de Gramenet, Catalonia, 08924

  • CAP Jaume I

    Tarragona, Catalonia, 43005

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Dextromethorphan 15 milligrams, Ipratropium Bromide 20Micrograms Inhaler, Honey 30 g (full tablespoon), Usual clinical practice
Keywords
Cough; Dextromethorphan; Ipratropium; Honey.
Medical subject headings
Bronchitis, Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dextromethorphan 15 milligramsDrug

    Also called Antitussive

    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 Bromide 20Micrograms InhalerDrug

    Also called Anticholinergic

    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 30 g (full tablespoon)Dietary supplement

    Also called Dietary supplement

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

  • Usual clinical practiceOther

    Also called 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.

Study groups in NCT03738917
Study groupRoleWhat they receive
DextromethorphanActive comparatorUsual clinical practice + dextromethorphan (15 milligrams unit), one 15 mg-tablet t.i.d. up to a maximum of 14 days.
Receives: Drug: Dextromethorphan 15 milligrams
IpratropiumActive comparatorUsual clinical practice + ipratropium bromide 20Micrograms Inhaler each puff), 2 puffs t.i.d. up to a maximum of 14 days.
Receives: Drug: Ipratropium Bromide 20Micrograms Inhaler
HoneyActive comparatorUsual 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.
Receives: Dietary Supplement: Honey 30 g (full tablespoon)
Usual clinical practicePlacebo comparatorUsual care.
Receives: Other: Usual clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Day 29.

Secondary outcomes (13)

  1. Duration of cough in days in the four arms.

    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).

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

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

    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).

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

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

    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).

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

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

    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).

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

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

    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).

    Measured: Days 15 and 29.

  6. Duration of symptoms in days in the four arms.

    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).

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

  7. Duration of moderate-severe cough in days according to the basal degree of bronchial hyper-reactiveness 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). 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.

    Measured: The peak-flow will be determined at day 1.

  8. Percentage of antibiotics and different symptomatic treatments used in the four arms.

    This information will be collected every day by the patients themselves.

    Measured: Days 2-4, 15 and 29.

  9. Number of days of absence from work in the four arms.

    Electronic records and sick leave certifications.

    Measured: Day 15.

  10. Patients re-attendance for symptoms related to the episode of acute bronchitis within the first 42 days.

    The number of re-attendances to any doctor regarding the episode of acute bronchitis will be collected from the electronic records.

    Measured: Day 29 and phone call at day 43.

  11. Number of complications related to the episode of acute bronchitis within the first 28-42 days.

    The number of complications will be collected through electronic records and hospital certifications.

    Measured: Day 29-43.

  12. Patient satisfaction in the four arms.

    Patient satisfaction will be collected in the same symptom diaries by the patients themselves by means of questions included in the symptom diary.

    Measured: Day 15 or 29.

  13. Number of adverse events in the four arms.

    The number of adverse events will be collected by the participating doctor by means of questions.

    Measured: Days 2-4, 15 and 29.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2018
  2. Study start1 Feb 2019
  3. Primary completion30 Nov 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicentre, pragmatic, parallel group, open randomized trial.
Masking
None (open label)
Enrolment
668 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03738917
Sponsor's protocol ID
IJG-AB4T-2018
Acronym
AB4T
Status last verified
Aug 2021
First submitted
5 Nov 2018
Last updated
30 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Reposition of data in Scientia

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. 2023 Mar 28;40(2):407-413. doi: 10.1093/fampra/cmac112.

    PubMed 36239199

  • 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.

    PubMed 31101700

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dextromethorphan 15 milligrams, Ipratropium Bromide 20Micrograms Inhaler and Honey 30 g (full tablespoon) in people with Acute Bronchitis, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 12 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of moderate-severe cough in days in the four arms. (time frame: Day 29.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03738917, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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