CompletedNot Applicable

Treatment of Adults With Acute Bronchitis in the Primary Healthcare Setting

Bulgaria310 participantsStarted 2024-01-30

Plain-language summary

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

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age of 18 to 60 years
✓. Clinical diagnosis of "Acute bronchitis" meeting the following criteria:
✓. 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.

✕. 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.
✕. 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:

Bronchitis severity assessment

Timeframe: Up to 14+2 days after starting treatment

NCT IDNCT06142994

SponsorNeopharm Bulgaria Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-20

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age of 18 to 60 years
✓. Clinical diagnosis of "Acute bronchitis" meeting the following criteria:
✓. 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.

✕. 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.
✕. 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: