Treatment of Adults With Acute Bronchitis in the Primary Healthcare Setting

NCT ID: NCT06142994

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-30
• Study Completion Date: 2024-06-20

Brief Summary

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

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.

Conditions

Acute Bronchitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Verum group

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)

Group Type: EXPERIMENTAL

Atusin CAP

Intervention Type: 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.

Placebo

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Atusin CAP

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Male and female ambulatory subjects

1. Age of 18 to 60 years

2. 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

3. Duration of symptoms ≤ 5 days before enrollment in the study;

4. Occurrence of initial symptoms (sputum production with impaired expectoration) within 2 days prior to initiation of study treatment;

5. Good physical and mental condition;

6. Non-smokers (Active smoking of < 5 cigarettes per day or subjects who stopped smoking at least six months before enrollment in the study).

7. BMI: 18,0 - 29,9 kg/m2

8. 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.

9. The subject has a smartphone and is capable of using it.

10. 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.

Exclusion Criteria

1. 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;

2. Concurrent bacterial infection;

3. Elevated body temperature (> 39,5°C rectal or ≥39,0°C axillary);

4. Subject administers antibiotics at the time of screening or for whom antibiotics are indicated, in the judgment of the Investigator;

5. History of cough lasting over 5 days;

6. Active smoking of ≥ 5 cigarettes per day;

7. Hypersensitivity to the study treatment;

8. 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);

9. 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;

10. Subjects in poor condition requiring urgent hospitalization, or planned hospitalization during the study;

11. Women who are pregnant or lactating;

12. Women who plan on getting pregnant during the study;

13. Participation in a clinical study within the last 8 weeks;

14. Evidence or suspicion of non-compliance;;

15. Risk of lost to follow-up;

16. Inability to give informed consent;

17. Alcohol or drug abuse in the last year;

18. Unstable medical conditions, as determined by the Investigator;

19. Inability to comply with the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neopharm Bulgaria Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir Hodzhev, Prof, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Diana Petkova, Prof, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Rossen Petkov, Prof, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Yavor Ivanov, Prof, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

University Hospital "St George"

Plovdiv, , Bulgaria

Countries

Bulgaria

References

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.

Reference Type: BACKGROUND

PMID: 25108123 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11119400 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16428698 (View on PubMed)

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/

Reference Type: BACKGROUND

PMID: 30422556 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23076965 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28837801 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32592670 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 41034950 (View on PubMed)

Other Identifiers

AАBA 2401-001

Identifier Type: -

Identifier Source: org_study_id