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Treatment of Adults With Acute Bronchitis in the Primary Healthcare Setting | Clinical Trials | Clareo Health

COMPLETEDNA

Treatment of Adults With Acute Bronchitis in the Primary Healthcare Setting

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.

NCT06142994•Neopharm Bulgaria Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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;
+5 more criteria

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;
+21 more criteria

Locations (1)

University Hospital "St George"

Plovdiv, Bulgaria

Key Dates

Start Date

January 30, 2024

Primary Completion Date

June 20, 2024

Completion Date

June 20, 2024

Last Updated

October 30, 2024

Enrollment

310

ACTUAL participants

Conditions

Acute Bronchitis

Interventions

Atusin CAP

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

To Evaluate the Efficacy and Safety of ALC-2203 in Patients With Acute Bronchitis

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Acute Bronchitis

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COMPLETEDPHASE3

A Study to Evaluate the Efficacy and Safety of DW5121 Compared to DW51211 and DW51212

NCT07093697

Acute Bronchitis

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COMPLETEDPHASE4

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment of Adults With Acute Bronchitis in the Primary Healthcare Setting

Inclusion Criteria

Exclusion Criteria

To Evaluate the Efficacy and Safety of ALC-2203 in Patients With Acute Bronchitis

A Study to Evaluate the Efficacy and Safety of DW5121 Compared to DW51211 and DW51212

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

Efficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children

The Development and Testing of a Scaling Strategy for a Community-Based Primary Care Antimicrobial Stewardship Program

Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life