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Acute BronchitisAАBANCT06142994

Treatment of Adults With Acute Bronchitis in the Primary Healthcare Setting

A study testing Atusin CAP in people with Acute Bronchitis, run by Neopharm Bulgaria Ltd. at 1 site in Bulgaria.

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

The study aims to evaluate the effectiveness and safety of Atusin® CAP in reducing the severity of acute bronchitis. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acute Bronchitis
What is being tested?
Atusin CAP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
310 participants
Where
1 siteBulgaria
Study dates
30 Jan 2024to 20 Jun 2024
Phase
Interventional
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male and female ambulatory subjects
  • Age of 18 to 60 years
  • Clinical diagnosis of "Acute bronchitis" meeting the following criteria:
  • ≥6 cough attacks in the day preceding the screening visit;
  • Bronchitis Severity Scale (BSS) ≥ 5 point at screening (out of 20 points maximum);
  • Cough severity of ≥4 on the Visual Analogue Scale (VAS) at screening
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  • Body temperature < 39.0°C
  • Duration of symptoms ≤ 5 days before enrollment in the study;
  • Occurrence of initial symptoms (sputum production with impaired expectoration) within 2 days prior to initiation of study treatment;
  • Good physical and mental condition;
  • Non-smokers (Active smoking of < 5 cigarettes per day or subjects who stopped smoking at least six months before enrollment in the study).
  • BMI: 18,0 - 29,9 kg/m2
  • In the judgement of the Investigator, the subject is capable of adhere with the visit schedule, complying with study treatment regimen and completing the study.
  • The subject has a smartphone and is capable of using it.
  • The subject must sign an informed consent form approved by an Ethics Committee and must agree to carry out the necessary visits to the site.

Who cannot join

  • History of or current confounding respiratory disease (for example, COPD, allergic rhinitis, chronic sinusitis or chronic bronchitis - including acute exacerbations, emphysema, bronchiectasias, asthma, cystic fibrosis, tuberculosis, lung cancer, etc.); lung radiogram revealing pulmonary inflammatory lesions; suspected pneumonia - imaging diagnostics is used mainly to rule out pneumonia.
  • ACCP 2006 Guidelines point out that an imaging assessment is not indicated in patients with symptoms of acute bronchitis, who have normal vital signs and normal pulmonary evaluation.33 Absence of the following findings reduces the likelihood of pneumonia sufficiently to eliminate the need of chest radiogram or hospital admission:
  • heart rate > 100 beats/min;
  • respiratory rate > 24 breaths/min;
  • oral body temperature > 39,0 C;
  • blood pressure: systolic < 90 mmHg, diastolic < 60 mmHg;
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  • SaO2 < 92%; If Investigator suspect pneumonia, the subject will not be enrolled in the study until the diagnosis of "Pneumonia" is ruled out;
  • Concurrent bacterial infection;
  • Elevated body temperature (> 39,5°C rectal or ≥39,0°C axillary);
  • Subject administers antibiotics at the time of screening or for whom antibiotics are indicated, in the judgment of the Investigator;
  • History of cough lasting over 5 days;
  • Active smoking of ≥ 5 cigarettes per day;
  • Hypersensitivity to the study treatment;
  • Active concurrent disease which may interfere with subject's ability to participate in the study, in the judgement of Investigator:
  • Sleep apnea;
  • Elevated liver enzymes (≥ 3 times the upper limit of normal (ULN));
  • Severe kidney dysfunction (glomerular filtration rate < 30 mL/min);
  • Uncontrolled diabetes mellitus (plasma glucose ≥ 250 mg/dL);
  • Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);
  • Active peptic ulcer and gastrointestinal bleeding; coagulopathy; cataract(s); advanced malignant disease; significant cardiac disease (for example heart failure class III/IV, pulmonary hypertension, peripheral artery disease);
  • Antibiotics, antivirals, steroids, anticoagulants; treatment with antitussives or expectorants in the 7 days prior to enrollment in the study; monoamine oxidase (MAO) inhibitors (for example, antidepressants, antipsychotics, or medications for Parkinson's disease) within 2 weeks prior to randomization;
  • Subjects in poor condition requiring urgent hospitalization, or planned hospitalization during the study;
  • Women who are pregnant or lactating;
  • Women who plan on getting pregnant during the study;
  • Participation in a clinical study within the last 8 weeks;
  • Evidence or suspicion of non-compliance;;
  • Risk of lost to follow-up;
  • Inability to give informed consent;
  • Alcohol or drug abuse in the last year;
  • Unstable medical conditions, as determined by the Investigator;
  • Inability to comply with the study protocol.

Trial locations and contacts

1 site in 1 country.

Bulgaria1 site

  • University Hospital "St George"

    Plovdiv

Other trials in Bulgaria

About this study

Official title: Phase 4, Efficacy and Safety of Atusin CAP in the Treatment of Subjects With Acute Bronchitis in the Primary Healthcare Setting: Prospective, Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-arm Clinical Study.

The study aims to evaluate the effectiveness and safety of Atusin® CAP in reducing the severity of acute bronchitis.

Read the detailed description

A prospective, multicenter, double-blind, placebo-controlled, randomized, parallel study will be conducted to evaluate the effect of Atusin® CAP on the rapid relief of irritating cough in adults with acute bronchitis treated in actual clinical practices in primary healthcare, where patients seek help as a result of serious complaints.

The combination of the three extracts: a mix of essential oils, bromelain and green Brazilian propolis may represent a breakthrough in symptomatic treatment by blocking the triggering mechanisms of cough due to acute bronchitis.

Being tested
Atusin CAP, Placebo
Keywords
Cough, Sputum, Mix of essential oils, Bromelain, Green Brazilian propolis, Acute Bronchitis, Adults
Medical subject headings
Bronchitis, Cough

What participants receive

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

  • Atusin CAPDietary supplement

    This food supplement contains a distillate of 4 types of purified oils - eucalyptus, sweet orange, lemon and myrtle, rich in 1,8-cineol, limonene, alpha-pinene in the ratio: 66:32:1:1, bromelain and green Brazilian propolis in a gastro-resistant capsule. The product contains excipients: microcrystalline cellulose, silica dioxide, copovidone, magnesium stearate.

  • PlaceboDietary supplement

    The placebo product will be identical in shape, appearance and color to the active product and will have the same composition but without the active ingredients.

Study groups in NCT06142994
Study groupRoleWhat they receive
Verum groupExperimental10 days of treatment with 3 daily doses of 420 mg (available in an capsule of 210 mg), as recommended by the manufacturer. 6 capsules daily for 10 days: 2 capsules in the morning (30 minutes before breakfast), 2 capsules at noon (30 minutes before lunch), 2 capsules in the evening (30 minutes before dinner)
Receives: Dietary Supplement: Atusin CAP
PlaceboPlacebo comparator10 days treatment with a 3-day dose of 420 mg placebo capsules (available in an indistinguishable capsule of 210 mg). 6 capsules daily for 10 days: 2 capsules in the morning (30 minutes before breakfast), 2 capsules at noon (30 minutes before lunch), 2 capsules in the evening (30 minutes before dinner)
Receives: Dietary Supplement: Placebo

What is being measured

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

  1. Bronchitis severity assessment

    The bronchitis severity assessment will be performed using the Bronchitis Severity Scale by the Investigator. The intensity of symptoms - frequency of coughing attacks, sputum discharge, rales on auscultation, chest pain on coughing and dyspnea will be assessed using a 5-point Likert scale: 0=Absent (1-2 times/day), 1=mild (3-5 times/day), 2=moderate (6-10 times/day), 3=severe (11-20 times/day), 4=very severe (>20 times/day).

    Clinical cure is defined as ⩾75% reduction in baseline Bronchitis Severity Scale after 10 days.

    Measured: Up to 14+2 days after starting treatment

Secondary outcomes (7)

  1. Reduction in cough severity

    The severity of the cough by Visual Analogue Scale (VAS) is a single element measure of the subject's current perception of the severity of the cough. It is rated on a scale of 10 cm (100 mm), where "0" stands for "Absent" and "10" represents "The most severe possible cough".

    The decrease in cough severity per VAS by ⩾ 20 mm is assumed to be significant in this study.

    Measured: Up to 14+2 days after starting treatment

  2. Reduction of the duration (in days) of moderate to severe cough

    Number of continuous days with moderate to severe cough. The severity of cough is assessed by the subject every evening at bedtime on Day 1 through Day 10, using the Visual Analogue Scale (VAS). The duration of moderate to severe cough will be calculated taking into account the number of consecutive days (2, 3,..10) in which the subject noted severity of cough of ≥ 5.

    Measured: up to 14+2 days after start of treatment

  3. Frequency of daytime cough attacks

    An attack is defined as a single cough of 3 or more consecutive coughs. Evaluated by:

    • Investigator at subject enrollment, during screening at Visit 1 (V1) (Day 1), and the data will serve as a baseline, and on V2, V3 and V4 using the Bronchitis Severity Scale.
    • Subject every evening at bedtime on Day 1 through Day 10, using an Acute Bronchitis Severity Score.

    Measured: Up to 14+2 days after start of treatment

  4. Reduction in the frequency of nocturnal cough

    The baseline frequency of cough attacks is evaluated by the Investigator at subject enrollment during screening Visit 1 (V1; CRF record) Day 1, using the Bronchitis Severity Scale and by the subject every evening at bedtime on Day 1 through Day 10, using the Acute Bronchitis Severity Score.

    The frequency of nighttime cough will be assessed daily from Day 1 (enrollment) to Day 10 and changes in its frequency will be analyzed after 1-10 days from baseline (change in day/night cough frequency after k days of treatment = frequency of day/night cough after k days of treatment - frequency of cough at enrollment (Day 1), where k = 1, 2,…,10).

    Measured: Up to 10 days after the start of treatment

  5. Quality of life (QoL)

    Limitation of daily activity is assessed by the Investigator at trial entry and by subject every evening at bedtime on Day 1 through Day 10 using the Acute Bronchitis Severity Score (ABSS).

    Measured: Up to 10 days after start of treatment

  6. Adverse events

    Incidence of mild (e.g. self-resolving), moderate (e.g. those requiring medical evaluation) and severe (e.g. those requiring prolonged hospitalization) serious and non-serious adverse events.. Recorded daily by the subjects in ePD and by Investigators in eCRF

    Measured: Up to 14+2 days after starting treatment

  7. Response to treatment

    At each visit during/after treatment (V2, V3 and V4), response to treatment is assessed by the Investigator using a verbal rating scale (VRS): 0 = symptoms resolved [resolved], 1 = symptoms improved compared to baseline, 2 = symptoms unchanged compared to baseline, 3 = symptoms worsened compared to baseline. Subjects with points 0 or 1 are defined as "responders"; subjects with points 2 or 3 were defined as "non-responders".

    Measured: Up to 14+2 days after starting treatment

Timeline

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

  1. First posted22 Nov 2023
  2. Study start30 Jan 2024
  3. Primary completion20 Jun 2024
  4. Study completion20 Jun 2024

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, multicenter, double-blind, placebo-controlled, randomized, parallel-arm clinical study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06142994
Sponsor's protocol ID
AАBA 2401-001
Acronym
AАBA
Status last verified
Nov 2023
First submitted
8 Nov 2023
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Clark TW, Medina MJ, Batham S, Curran MD, Parmar S, Nicholson KG. Adults hospitalised with acute respiratory illness rarely have detectable bacteria in the absence of COPD or pneumonia; viral infection predominates in a large prospective UK sample. J Infect. 2014 Nov;69(5):507-15. doi: 10.1016/j.jinf.2014.07.023. Epub 2014 Aug 6.

    PubMed 25108123

  • Gonzales R, Sande MA. Uncomplicated acute bronchitis. Ann Intern Med. 2000 Dec 19;133(12):981-91. doi: 10.7326/0003-4819-133-12-200012190-00014.

    PubMed 11119400

  • Braman SS. Chronic cough due to acute bronchitis: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):95S-103S. doi: 10.1378/chest.129.1_suppl.95S.

    PubMed 16428698

  • Tobin EH, Thomas M, Bomar PA. Upper Respiratory Tract Infections With Focus on The Common Cold. 2025 May 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532961/

    PubMed 30422556

  • Tackett KL, Atkins A. Evidence-based acute bronchitis therapy. J Pharm Pract. 2012 Dec;25(6):586-90. doi: 10.1177/0897190012460826. Epub 2012 Oct 16.

    PubMed 23076965

  • Malesker MA, Callahan-Lyon P, Ireland B, Irwin RS; CHEST Expert Cough Panel. Pharmacologic and Nonpharmacologic Treatment for Acute Cough Associated With the Common Cold: CHEST Expert Panel Report. Chest. 2017 Nov;152(5):1021-1037. doi: 10.1016/j.chest.2017.08.009. Epub 2017 Aug 22.

    PubMed 28837801

  • Bagcchi S. Stigma during the COVID-19 pandemic. Lancet Infect Dis. 2020 Jul;20(7):782. doi: 10.1016/S1473-3099(20)30498-9. No abstract available.

    PubMed 32592670

  • Petkova D, Petkov R, Hodzhev V, Ivanov Y, Hadjiev V. Efficacy and safety of Atusin(R) CAP in the treatment of acute uncomplicated bronchitis in the primary care setting: a multi-center, randomized, double-blind, placebo-controlled study (AABA). BMC Pulm Med. 2025 Oct 1;25(1):443. doi: 10.1186/s12890-025-03912-6.

    PubMed 41034950

Questions about this trial

What is this clinical trial studying?

A study testing Atusin CAP in people with Acute Bronchitis, run by Neopharm Bulgaria Ltd. at 1 site in Bulgaria.

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 15 inclusion and 31 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bulgaria. 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.

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?

Bronchitis severity assessment (time frame: Up to 14+2 days after starting treatment). 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 NCT06142994, which also lists 8 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 Oct 2024.

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