Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Acute Bronchitis. (AB4T)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03738917
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

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

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.

Layout table for study information
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, 2020
Estimated Study Completion Date : December 31, 2020


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.
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

Active Comparator: Ipratropium
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
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

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.
Dietary Supplement: Honey 30 g (full tablespoon)
This study product will be provided free to the participants by the sponsor.
Other Name: Dietary supplement

Placebo Comparator: Usual clinical practice
Usual care.
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 :
  1. 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 :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. Number of days of absence from work in the four arms. [ Time Frame: Day 15. ]
    Electronic records and sick leave certifications.

  10. 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.

  11. 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.

  12. 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.

  13. 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location contacts
Contact: Carl Llor, MD PhD 693696644 carles.llor@gmail.com
Contact: Ana Garcia-Sangenis, MD 0034934824124 agarcia@idiapjgol.org

Locations
Layout table for location information
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 - CAIBER
Investigators
Layout table for investigator information
Study Chair: Ana Moragas, MD PhD Catalan Institute of Health

Layout table for additonal information
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03738917     History of Changes
Other Study ID Numbers: IJG-AB4T-2018
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: November 2018
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

Layout table for additional information
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:
Cough; Dextromethorphan; Ipratropium; Honey.

Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Asthmatic Agents
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Bromides
Dextromethorphan
Antitussive Agents
Ipratropium
Phenylpropanolamine
Guaifenesin
Cholinergic Antagonists
Chlorpheniramine, phenylpropanolamine drug combination
Anticonvulsants
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
Cholinergic Agents
Expectorants