Treatment of Adults With Acute Bronchitis in the Primary Healthcare Setting

NCT06142994 | Completed

• 1 other identifier: AАBA 2401-001
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Bronchitis

Keywords

Cough; Sputum; Mix of essential oils; Bromelain; Green Brazilian propolis; Acute Bronchitis; Adults

Outcome Measures

Primary Outcomes (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.

  Up to 14+2 days after starting treatment

Secondary Outcomes (7)

• Reduction in cough severity

  Up to 14+2 days after starting treatment

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

  up to 14+2 days after start of treatment

• Frequency of daytime cough attacks

  Up to 14+2 days after start of treatment

• Reduction in the frequency of nocturnal cough

  Up to 10 days after the start of treatment

• Quality of life (QoL)

  Up to 10 days after start of treatment

Study Arms (2)

Verum group

EXPERIMENTAL

10 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)

Dietary Supplement: Atusin CAP

Placebo

PLACEBO COMPARATOR

10 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)

Dietary Supplement: Placebo

Interventions

Atusin CAP DIETARY_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.

Verum group

Placebo DIETARY_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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Neopharm Bulgaria Ltd.: lead

Study Sites (1)

University Hospital "St George"

Plovdiv, Bulgaria

Location

Related Publications (8)

• 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.

  PMID: 25108123 BACKGROUND

• 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.

  PMID: 11119400 BACKGROUND

• 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.

  PMID: 16428698 BACKGROUND

• 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; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532961/

  PMID: 30422556 BACKGROUND

• 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.

  PMID: 23076965 BACKGROUND

• 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.

  PMID: 28837801 BACKGROUND

• 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.

  PMID: 32592670 BACKGROUND

• 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.

  PMID: 41034950 DERIVED

MeSH Terms

Conditions

Bronchitis; Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vladimir Hodzhev, Prof, PhD

  Head of Pulmonology clinic in the UMHAT "Sveti Georgi", Medical University-Plovdiv

  PRINCIPAL INVESTIGATOR

• Diana Petkova, Prof, PhD

  Clnic of Pneumology at UMHAT "St. Marina", Medical University - Varna

  PRINCIPAL INVESTIGATOR

• Rossen Petkov, Prof, PhD

  Head of Pulmonology clinic in the UMHAT St Ivan Rilski, Medical University of Sofia

  PRINCIPAL INVESTIGATOR

• Yavor Ivanov, Prof, PhD

  Head of Pneumology and Phthisiology clinic in the UMHAT "Dr. Georgi Stranski"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators will be provided with coded and identical products. Each individual involved in the study will be blinded to the assignment until study completion. Considering the established safety profile, emergency unblinding of treatment assignment will not be necessary, and no copies of the treatment assignments will be stored at the enrollment sites. If needed, the Investigators may receive information about the assignment of a particular subject only after review and approval by the Medical monitor. No information about the subjects will be shared with the company conducting the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, double-blind, placebo-controlled, randomized, parallel-arm clinical study

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 22, 2023
• Study Start: January 30, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: October 30, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)