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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bronchitis severity assessment

Timeframe: Up to 14+2 days after starting treatment

Trial details

NCT IDNCT06142994

SponsorNeopharm Bulgaria Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-20

View on ClinicalTrials.gov More Acute Bronchitis trials