Health TrialsbyHealthPanel

Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients

ConditionsBronchitisAcute Bronchitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorMateria Medica Holding

About this trial

The goal of this clinical trial is to learn if Raphamin works to treat acute bronchitis in adults. It will also learn about the efficacy and the safety of Raphamin. The main questions it aims to answer are:

Will treatment with Rafamine contribute to a faster resolution of acute bronchitis symptoms, reduce the severity of the disease, and prevent the development of complications requiring antibacterial therapy compared to placebo therapy? Investigators will compare Raphamin to a placebo (a look-alike substance that contains no drug) to see if Raphamin works to treat acute bronchitis.

Participants will:

Take Raphamin or a placebo for 5 days. On the first day of treatment 8 tablets of Raphamin or a placebo should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day.

Face-to-face visits are planned in the trial: Visit 1 (Day 1), Visit 2 (Day 4±1), Visit 3 (Day 7±1), and a phone Visit 4 (day 14±1). The study uses an electronic patient diary (EPD) in which symptoms of acute bronchitis (cough, sputum, chest pain during coughing) are assessed daily.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients aged 18 to 64 years, inclusive.

Confirmed diagnosis of acute bronchitis (AB) based on the presence of productive cough and one or more symptoms (wheezing in the lungs, chest "discomfort", shortness of breath, fever).

The BSS score of at least 5 and no more than 15 points.

Duration of AB symptoms does no more than 72 hours.

Disqualifiers

History of chronic obstructive pulmonary disease, chronic bronchitis, asthma, bronchiectasis, or pulmonary emphysema.

Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring antibiotics, starting on the first day of illness.

Suspected infiltrative pulmonary tuberculosis, pulmonary embolism, pulmonary infarction, drug-induced (toxic) pneumopathy, foreign body aspiration, sarcoidosis, pulmonary alveolar proteinosis, lipoid pneumonia, or atelectasis.

History of immunopathological diseases: systemic vasculitis, lupus pneumonitis, allergic bronchopulmonary aspergillosis, obliterating bronchiolitis, idiopathic pulmonary fibrosis, eosinophilic pneumonia, bronchocentric granulomatosis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Raphamin

    Drug

    Oral administration

  • Placebo

    Drug

    Oral administration

Treatment groups

308 Participants
are divided into 2 treatment groups
Group A: RaphaminExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with the Bronchitis Severity Scale, (BSS) score of 4 points or less

To evaluate and compare the proportion of patients with the Bronchitis Severity Scale (BSS) score of 4 points or less in two groups (Raphamin and Placebo) on day 4 of treatment. Minimum and maximum values: 0 to 20 points. Higher scores mean a worse outcome (greater clinical severity of acute bronchitis), while lower scores indicate milder symptoms or improvement.

Time frame
On day 4

Secondary outcomes

1

Change in the total Bronchitis Severity Scale, (BSS) score

To assess and compare the change in the total BSS score in two groups (Raphamin and Placebo) compared to baseline over 7 days. Minimum and maximum values: 0 to 20 points. Higher scores mean a worse outcome (greater clinical severity of acute bronchitis), while lower scores indicate milder symptoms or improvement.

Time frame
7 days
2

Proportion of patients with the BSS score of 4 points or less

To evaluate and compare the proportion of patients with the BSS score of 4 points or less in two groups (Raphamin and Placebo) on observation day 7.

Time frame
On day 7
3

Proportion of patients with a decrease in the BSS score by 5 points or more

To evaluate and compare the proportion of patients with a decrease in the BSS score by 5 points or more in two groups (Raphamin and Placebo) as compared to baseline on observation days 4 and 7.

Time frame
On 4 and 7 days
4

Change in the severity of acute bronchitis symptoms (cough, sputum, and chest pain)

To evaluate and compare the change in the severity of acute bronchitis symptoms (cough, sputum, chest pain during cough) in two groups (Raphamin and Placebo) based on the EPD data as compared to baseline throughout the entire period of treatment and follow-up (14 days). Three key symptoms (cough, sputum, and chest pain) are each assessed on a scale from 0 to 4 points.Outcome Interpretation: higher scores mean a worse outcome (greater severity of the symptom), where 0 represents the absence of the symptom and 4 represents the maximum severity.

Time frame
14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Materia Medica Holding

Lead sponsor

Source ClinicalTrials.gov
Apply now